ISO 9001:2000 Document Development Compliance Manual
A COMPLETE GUIDE and CD-ROM Syed Imtiaz Haider, Ph.D.
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ISO 9001:2000 Document Development Compliance Manual
A COMPLETE GUIDE and CD-ROM Syed Imtiaz Haider, Ph.D.
St. Lucie Press Boca Raton London New York Washington, D.C.
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Library of Congress Cataloging-in-Publication Data Haider, Syed Imtiaz. ISO 9001:2000 document development compliance manual : a complete guide and CD-ROM / Syed Imtiaz Haider. p. cm. Includes bibliographical references. ISBN 1-57444-308-9 (alk. paper) 1. ISO 9000 Series Standards—Handbooks, manuals, etc. I. Title. TS156.6 .H32 2001 658.5′62—dc21
2001019637
This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe.
Visit the CRC Press Web site at www.crcpress.com © 2001 by CRC Press LLC St. Lucie Press is an imprint of CRC Press LLC No claim to original U.S. Government works International Standard Book Number 1-57444-308-9 Library of Congress Card Number 2001019637 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper
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PREFACE The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM provides guidelines to those involved in the development of quality system manuals and applicable standard operating procedures (SOPs) to comply with the requirements of international standard ISO 9001:2000 and proceed with the registration/certification process. The quality manuals (models) and SOPs provided in the CD-ROM are also a valuable tool for the companies to transform their existing ISO 9001, ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards. The text provides explicit documentation packages to the end users globally, to develop documentation without spending a lot of money and resources. The information provided will serve as the first milestone to lead companies to ISO 9000 registration/certification. The CD-ROM is user-friendly and provides meaningful understanding of documentation requirements, which can be adopted by any company after minor changes suitable to their operations. The contents of the quality manuals and SOPs are written in simple and precise language to be in compliance with revised international standard ISO 9001:2000 and provide readers and front-line management with all the information they need to make a successfully documented quality system. The manual will ensure the minimization of documents, to avoid the nightmare of management representatives at the time of a registration/certification audit. The text refers to the elements of the standards, however, specific working formats are not included to ensure that the electronic package can be used by a diversified range of industries and organizations.
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ACKNOWLEDGMENTS The author would like to thank his friends and colleagues for their help and encouragement in this endeavor and for creating a professional environment that demanded the development of this manual. He would also like to thank the staff of CRC Press, particularly Drew Gierman, for his patience and diligence in the production of this work. Syed Imtiaz Haider
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THE AUTHOR Syed Imtiaz Haider has a Ph.D. in chemistry and is a quality assurance specialist with over 10 years of experience in aseptic and nonaseptic pharmaceutical processes and equipment validation, in-process control, and auditing. Dr. Haider is the author and co-author of more than 20 research publications in international journals dealing with products of pharmaceutical interest, their isolation, and structure development. He is a professional technical writer and author of more than 500 standard operating procedures based on FDA regulations, ISO 9000, and ISO 14000 standard. Dr. Haider is a certified auditor of IRCA and a registered provisional environmental auditor of EARA.
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ABOUT THE MANUAL This manual takes into account documentation of quality manuals and applicable procedures based on quality elements described in international standard ISO 9001:2000. No other manual in print deals exclusively with the key elements of quality and provides hands-on templates to be tailored to achieve ISO 9000 registration/certification. ISO 9001:2000 quality manuals, together with 20 standard operating procedures, provide explicit instructions on how to achieve the standard for anyone responsible for writing and executing quality manuals and applicable procedures. Included herein is the ready-to-use template on a CD-ROM that one can immediately use as his own without “reinventing the wheel,” thus saving time and money without missing any critical quality elements. This manual provides instant answers for quality professionals, quality assurance managers, auditors, and protocol writers regarding what should be made part of quality manual standards and ISO 9000 standard operating procedures to enhance productivity.
INTRODUCTION
Objective What is Quality? Correspondence between ISO 9001:1994 and ISO 9001:2000 The Basic Changes Documentation and Registration/Certification
QUALITY SYSTEMS MANUALS Model-1: Quality Manual ISO 9001:2000 Model-2: Quality Manual ISO 9001:2000 ix
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Model-3: Quality Manual ISO 9001:2000 Model-4: Quality Manual ISO 9001:2000
STANDARD OPERATING PROCEDURES
Management Responsibility Quality Systems Contract Review Design Control Document and Data Control Purchasing Customer-Supplied Product Product Identification and Traceability Process Control Inspection and Testing Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Nonconforming Product Corrective Action Handling, Storage, Packaging, and Delivery Quality Records Internal Quality Audits Training Servicing Statistical Techniques
APPENDICES Recommended Readings
INDEX The manual is designed especially for individuals involved in writing and executing quality manuals and applicable procedures. This manual provides a complete, single-source reference which details quality manuals and over 20 explicit procedures based on quality elements described in the ISO 9001:2000 international standard.
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CONTENTS 100.10
Objective 100.10.1 100.10.2 100.10.3 100.10.4
200.20
Quality Manuals 200.20.1 200.20.2 200.20.3 200.20.4
300.30
What is Quality? ................................................................... 8 Correspondence between ISO 9001:1994 and ISO 9001:2000............................................................. 12 The Basic Changes ............................................................ 22 Documentation and Registration/Certification................. 26 Model-1: Model-2: Model-3: Model-4:
Quality Quality Quality Quality
Manual Manual Manual Manual
ISO ISO ISO ISO
9001:2000 ......................... 32 9001:2000 ....................... 122 9001:2000 ....................... 186 9001:2000 ....................... 248
Standard Operating Procedures 300.30.1 300.30.2 300.30.3 300.30.4 300.30.5 300.30.6 300.30.7 300.30.8 300.30.9 300.30.10 300.30.11 300.30.12 300.30.13 300.30.14 300.30.15 300.30.16 300.30.17 300.30.18
Management Responsibility............................................. 308 Quality Systems................................................................ 314 Contract Review ............................................................... 324 Design Control ................................................................. 330 Document and Data Control .......................................... 340 Purchasing ........................................................................ 348 Control of Customer-Supplied Product.......................... 352 Product Identification and Traceability .......................... 356 Process Control ................................................................ 360 Inspection and Testing .................................................... 366 Inspection, Measuring, and Test Equipment ................. 372 Inspection and Test Status .............................................. 376 Control of Nonconforming Product ............................... 380 Corrective Action ............................................................. 384 Handling, Storage, Packaging, and Delivery ................. 388 Quality Records................................................................ 392 Internal Quality Audits .................................................... 396 Training............................................................................. 402
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300.30.19 300.30.20
Servicing ........................................................................... 406 Statistical Techniques....................................................... 410
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INTRODUCTION The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM is designed and written for the quality professionals, auditors, managers, supervisors, and management representatives who are responsible for writing and maintaining quality management systems for the successful operation of their companies. This document provides a set of three model ISO 9001:2000 quality manuals and applicable standard operating procedures (SOPs) revised on the basis of ISO 9001:2000 international standard. These can be used to manage and document critical elements in an organization in order to build quality into the products and services provided by the company. The numbering of the sections and the related quality manuals and SOPs begin with 100 and go through 300. In addition, the reader may add SOPs that are unique to his products and services. The term management representative is used extensively throughout the SOPs. It refers to the person who has been delegated the authority by organizational management and deemed responsible for performing the duties associated with management of the quality system. The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM is comprised of the following three sections. Objective: This section describes the meaning of quality correspondence between ISO 9001:1994 and international standard ISO 9001:2000 and basic changes in ISO 9001:2000 international standard. It also provides a time line chart and documentation, and describes the registration/certification process. Quality Manuals: Four template quality manuals are provided as models. Quality manual Model-1 can be directly adopted by a company planning for the first time for registration/certification to an international standard ISO 9001:2000. Model-2 will be useful for a xiii
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company in possession of ISO 9001 registration/certification that intends to revise its quality manual and quality system. Organizations already holding the ISO 9002 and ISO 9003 quality manuals may refer to Model-3 and Model-4, respectively, to incorporate changes in the existing ISO 9002 and ISO 9003 quality manuals in order to be in compliance with the requirements of the ISO 9001:2000 standard. Standard Operating Procedures: This provides 20 explicit template procedures that can be adopted after minor changes suitable to each company’s operations.
QUALITY MANUAL FORMAT Your Company Name: At the top of each page of the quality manual space is provided to enter your company name. Quality System Manual: The quality manual is assigned a space to indicate the standard used to document the quality management system. Manual Serial Number: Each quality manual is assigned a unique number that appears at the upper right hand corner of the page. Revision Number: At the right hand corner of each page is the revision number box, which is provided to document the revision number. Written by: The quality manual is assigned a space to provide the author name, title, and the department with signatures and the date. Checked by: The quality manual is assigned a space to provide the name of the person responsible for the verification of the contents of the manual, the title, and the department with signatures and the date. Approved by: Each page of the quality manual has a space to provide the name, title, and department of the person in the quality assurance unit or the management representative approving the manual with signatures and the date. Date Supersedes: Each page of the quality manual is assigned a space to indicate the issue date of the manual superseded. Date Issued: Each page of the quality manual is provided with a space to provide the manual’s issue date. Distributed to: Each top page of the quality manual is assigned a space to indicate the recipients of the manual. Controlled Copy Number: Each front page of the quality manual is assigned a space to provide the copy number assigned to the manual for distribution.
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Introduction
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Section, Clause: Each page of the quality manual has a box to indicate the section and the applicable clause. Reasons for Revision: On the top page of the quality manual, space is provided to describe the reasons for revision of the procedure with the date. Reference SOP Number: On the last page of each clause described in the quality manual, space is provided to write the applicable SOP number.
SOP FORMAT All SOPs have been designed and formatted to have the same look, and similar information is located in the same place on all SOPs. Information common to all SOPs is described below. Your Company Name: At the top of each page of an SOP, space is provided to enter your company name. Subject: The subject of each SOP appears at the upper left hand corner of the SOP and describes the quality element described in the SOP. SOP Number: Each SOP is assigned a unique number that appears at the upper right hand corner of the SOP, based on the reference clause of the ISO 9000 series of standard. Corresponding Clause: All SOPs are provided with a space in the second line of the SOP’s header to provide reference to the corresponding clause of an international standard ISO 9001:2000. Distributed to: Each SOP is assigned a space to list the recipients of the SOP. Based on: Each SOP is assigned a space to list the applicable ISO 9000:1994 series of standard. Revision Number: At the right hand corner of each page is the revision number box. The box is provided to document the revision number. Written by: Each SOP is assigned a space to provide the author name, title, and department with signatures and the date. Checked by: Each SOP is assigned a space to provide the name of the person responsible for the verification of the procedure, title, and department with signatures and the date. Approved by: Each page of the SOP has a space to provide the name, title, and department of the person in the quality assurance unit or the management representative approving the SOP with signatures and the date.
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Date Supersedes: Each page of the SOP is assigned a space to indicate the issue date of the SOP superseded. Date Issued: Each page of the SOP is provided with a space to provide the SOP issue date. Page Number: Each SOP page is numbered. Purpose: Each SOP is supported with reasons, describing the purpose of that SOP. Responsibility: Each SOP is supported with responsibility, describing the department and the employee responsible for implementing the procedure. Definition: Where necessary, definitions are provided in the SOP for better understanding. Procedure: Following the responsibility statement are the individual steps of the SOP. These are arranged in logical order and numbered sequentially to make the SOP easy to perform, and they are based on the ISO 9000:1994 series of standards. Reasons for Revision: At the end of each SOP, space is provided to describe the reasons for the revision of the procedure with the date. CD-ROM: An electronic copy of the quality manuals and SOPs are provided. See pg. 413 of this manual for the CD-ROM instructions.
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RECOMMENDED READINGS 1. ISO 9000-3:1997, Quality Management and Quality Assurance Standards — Part 3: Guidelines for the Application of ISO 9001:1994 to the Development, Supply, Installation, and Maintenance of Computer Software. 2. ISO 9004: Quality Management Systems — Guidelines for Performance Improvements. 3. ISO 10005:1995, Quality Management — Guidelines for Quality Plans. 4. ISO 10006:1997, Quality Management — Guidelines to Quality in Project Management. 5. ISO 10007:1995, Quality Management — Guidelines for Configuration Management. 6. ISO 10011-1:1990, Guidelines for Auditing Quality Systems — Part 1: Auditing. 7. ISO 10011-2:1991, Guidelines for Auditing Quality Systems — Part 2: Qualification Criteria for Quality Systems Auditing. 8. ISO 10011-3:1991, Guidelines for Auditing Quality Systems — Part 3: Management of Audit Programs. 9. ISO 10012-1:1992, Quality Assurance Requirements for Measuring Equipment — Part 1: Metrological Confirmation System for Measuring Equipment. 10. ISO 10012-2:1997, Quality Assurance for Measuring Equipment — Part 2: Guidelines for Control of Measurement Processes. 11. ISO 10013:1995, Guidelines for Developing Quality Manuals. 12. ISO/TR 10014:1998, Guidelines for Managing the Economics of Quality. 13. ISO 10015, Quality Management — Guidelines for Training. 14. ISO/TR 10017:1999, Guidance on Statistical Techniques for ISO 9001:1994. 15. ISO/TC 178/SC 2/N 378, Quality Management Principles and Guidelines on Their Application. 16. ISO 9001:2000, Quality Management Systems Requirements.
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OBJECTIVE This manual is written in general terms so that it can be used as a procedural guideline by the individual responsible for writing quality manuals and applicable standard operating procedures and programs. The format of this manual, these procedures, and the numbering system can easily be used by small to large companies and are acceptable to ISO certification bodies. The CD-ROM consists of manuals and procedures that should be useful to all companies. As the ISO 9000 series of quality standards becomes more widely adopted by organizations, both in the United States and elsewhere in the world, it is essential for compliant companies to create quality systems manuals and applicable standard operating procedures (SOPs) for their employees. These SOPs enable both new and experienced staff to understand the requirements of the ISO 9000 series of standards, along with the principles and practices of the company, and comply with these regulations to build the elements of quality into their products and services with a particular reference to customer satisfaction. For companies already in compliance with the ISO 9000 series of standards, and who are registered, certified, and have long since developed and adopted the quality manual and SOPs, this manual will help them have an easy transition to the new international standard ISO 9001:2000 requirements. This ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM will be of enormous value to recently emerged companies with a big investment in the slogan of quality. While these companies are few, if any, they will have the expertise to fully understand the elements of quality and achieve registration/certification. The ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM with an included CD-ROM provides an administrative solution for management both in text and software. The quality manuals and standard operating procedures on the CD-ROM are valuable tools, especially for those companies in the process of applying or planning to apply for registration in the future. The documentation package is especially relevant to quality management representatives, designers, internal auditors, and external auditors or to anyone interested in developing a documented quality system. The ISO 9000 series of standards (1994) was based on the “process approach.” The management organizations that have adopted the 1994 edition of the standards had to describe their business processes and develop quality manuals and procedures needed to support them. The revised ISO 9001:2000 international standard model is very clear; it encourages the adoption of the process approach as a means of readily identifying and managing opportunities for improvement. The present family of 21 standards in the ISO 9000 series is reduced to five.
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The development, implementation, and maintenance of a quality manual and key SOPs are essential for compliance with the ISO 9000 series of standards and are a requirement of the international standard ISO 9001:2000. Writing SOPs can be time consuming for those new to the system. Moreover, the standards do not specify how SOPs are to be written, what format they should be in, or how many procedures are enough. Those new to international standard ISO 9001:2000 compliance may have difficulty knowing the best route to take. Generally, companies new to applying for registration are allowed an adequate amount of time for remedial action and demonstration of their commitment and continuous improvement. Documentation management can, however, minimize the number of adverse findings for incomplete or missing SOPs and prevent repeated adverse findings by making the development of SOPs a top priority. The quality manuals and pr ocedures provided in an electronic form can be easily adapted to any facility’s needs and style. The text and CD-ROM provide end users with resource data to develop and improve their quality system without spending a lot of money on consultants or “reinventing the wheel.” The SOPs are made available in such a form that end users can input them into their computer and use their own Microsoft Word program to edit and print these documents. The contents of the quality manuals are written in simple, precise, and global text in order to be in compliance with the elements of international standard ISO 9001:2000, which r eplaces the second edition of ISO 9001:1994 together with ISO 9002 (1994) and ISO 9003 (1994). The quality manuals and procedures provide users and frontline managers with all the information they need to make a successful documented quality system based on the international standard ISO 9001:2000 series of standards. The contents of the manual are divided into three major sections: objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001:2000, and the process of documentation development and application for registration and certification. The second section contains four template quality manuals written in compliance with international standard ISO 9001:2000 to provide the statement of company approach and declaration of interest as to how the requirements of the ISO 9001:2001 quality management standard are to be addressed. This section is comprised of four sample quality manuals presented as Model-1, Model-2, Model-3, and Model-4, respectively.
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Model-1 The quality manual is prepared and maintained in accordance with ISO 9001:2000, without permissible exclusions.
Model-2 The ISO 9000 series of standards has been adopted by thousands of companies worldwide since the introduction of registration and certification. Considering the fact that transition to the r evised standard ISO 9001:2000 will take time, Model-2 can be used wher e quality manual ISO 9001 already exists and needs to be revised in accordance with the requirements of ISO 9001:2000. Reference is made to the applicable clauses of ISO 9001 and ISO 9001:2000. No exclusions are permitted in Model-2.
Model-3 This model was developed for companies already holding ISO 9002 registration/certification and intending to immediately comply with the changes recommended in international standard ISO 9001:2000. Model-3 represents the revision of the ISO 9002 quality manual in accordance with the applicable clauses of the ISO 9001:2000 standard. Sub-clause 7.3 of design and/or development is excluded from the Model-2 quality manual.
Model-4 The last model is the quality manual for companies already registered, certified and in compliance with the ISO 9003 (1994) standard. The adoption of Model-4 will facilitate effective transition to the requirements of international standard ISO 9001:2000. Following are the permissible exclusions: Sub-clause 7.1: planning of product realization Sub-clause 7.2.3: customer communication Sub-clause 7.3: design and development Sub-clause 7.4: purchasing Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of processes for production and service provision Sub-clause 7.5.3: identification and traceability The Model-1 quality manual can be directly adopted by companies planning to register/certify to international standard ISO 9001:2000 for the first time. Model-2 is useful for companies in possession of ISO 9001
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registration/certification who intend to revise their quality manual and system. Organizations already holding ISO 9002 and ISO 9003 quality manuals may refer to Model-3 and Model-4, respectively, to incorporate changes into their existing ISO 9002 and ISO 9003 quality manuals in order to be in compliance with the requirements of the ISO 9001:2000 standard. The last section of this book provides a set of 20 explicit standard operating procedures written in a global text to describe the elements of the revised standard. The contents of the procedures can be specifically tailored to an individual company’s operations, and reference can be made to specific documents and associated applicable procedures. Taking into consideration the fact that thousands of companies are already registered and certified in compliance with the ISO 9001 (1994) or ISO 9002 (1994) or ISO 9003 (1994) international standards, reference is made to the corresponding SOPs to indicate applicable clauses of both the second and the third revisions of the ISO 9000 series of standards.
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100.10.1
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WHAT IS QUALITY? The official definition of quality is, “the totality of features and characteristics of a product or service that bear upon its ability to satisfy stated or implied needs” (ISO 8402). Well-planned design is one of the major contributing factors to achieving quality within a product or service. It is therefore necessary to carefully control critical elements of a company’s documentation system with particular reference to each phase of design in order to ensure that the effects on the end products or services are not disastrous and are based on customer requirements. To be successful, an organization must offer services and products that meet a well-defined purpose or need. A company must satisfy its users, including delivery time scales. It should be ensured that applicable standards, statuary requirements, and specifications are in compliance. The offered product or services should be within budget and provide value. Companies should ensure that their total operations are carefully reviewed before implementation to reduce the occurrence of error and quickly correct any error inadvertently made. Control should be demonstrated on changes through proactive communication and feedback loops between the company and external interfaces. Training needs must be identified to promote efficiency and cost-effectiveness. Over the past decade, we have seen drastic changes in the world around us. There has been more competition in terms of quality, and companies have to do more work, accomplish targets, and be proactive rather than reactive. All this must be accomplished with fewer people. In addition, the quality must be better than ever, due to competitive forces and consumer demands. Since the beginning of the new millennium, it is evident that we are working in a global village where it is impossible for a company to survive without offering quality products and services. The quest to achieve excellence in products and services should be every company’s mission, which can only be achieved with a vision to implement a documented quality system based on a globally accepted standard (to overcome economic barriers). Compliance to global international standard ISO 9001:2000 will lead your company to: Supply products that are totally fit for use Satisfy its users’/customers’ expectations and contractual requirements Yield profits on the invested resources Achieve and sustain defined levels of quality Comply with applicable standards and specifications Prevent defectives, rather than detect them Provide value for money
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Supply products within delivery time scales agreed upon/required by the user/customer Comply with environmental requirements Work in harmony within an organization without productivity losses
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CORRESPONDENCE BETWEEN ISO 9001:1994 AND ISO 9001:2000 A number of quality systems standards are in operation worldwide. Their division into categories is based on the scope of their subject matter. ISO (International Standardization Organization) is a Geneva-based worldwide federation of national bodies that normally work together to prepare international standards through technical committees (TC). Each member body interested in a subject for which a TC has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with the ISO, also participate in the work. The U.S. representative to the ISO is the American National Standards Institute (ANSI). The International ISO 9000:1994 series of standards has been established and is based on the British Standard 5750:1987 series, European Standard EN 29000:1987 series, and Inter national Standard ISO 9000:1987 series. The third edition of ISO 9001 cancels and replaces the second edition (ISO 9000:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a revision of these documents. Those organizations that have used ISO 9002:1994 and ISO 9003:1994 in the past may use this revised international standard by excluding certain requirements in accordance with Clause 1.2 of ISO 9001:2000. It should be noted that where the exclusives in sub-clause 1.2 of ISO/FDIS 9001:2000 are exceeded, conformity to ISO/FDIS 9001:2000 shall not be cleared. All requirements of the revised standard are generic and are applicable to all organizations, regardless of type, size, and products offered. If any requirements of this international standard cannot be applied due to the nature of an organization, its products can be considered for exclusion. The publication of BS EN ISO 9001:2000 has implications for Council Decision 93/465/EEC of July 22, 1993 concerning the modules for the various phases of conformity assessment procedures and the rules for affixing and using the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the modules used in individual technical harmonization directives may vary in some respects compared to those described in Council Decision 93/465/ECC. In all cases, it is the annex of the applicable directive(s) that is legally binding. The principles set out in this foreword remain valid regardless of these variations. Three of the modules cited in the council decision, i.e., modules E, D, and H, require that “the manufacturer must operate an approved quality system.” The scope of the quality systems r equired by these modules addresses:
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Final product inspection and testing (module E) Production, final inspection, and testing (module D) Design manufacture, final product inspection, and testing (module H) Council Decision 93/465/EEC specifies that conformity to the harmonized standards EN 29001, EN 29002, or EN 29003 provides a presumption of conformity to the relevant requirements of modules H, D, and E. EN 29001, EN 29002, and EN 29003 were suspended by EN ISO 9001:1994, EN ISO 9002:1994, and EN ISO 9003:1994, respectively, which, in turn, are now superseded by EN ISO 9001:2000. Where organizations wish to implement quality management systems in conformance with modules E, D, or H, they may use EN ISO 9001:2000. In seeking compliance with modules D, E, or H, an organization may exclude specific requirements. Only those requirements in clause 7 of ISO 9001:2000 pertaining to the difference between modules E, D, and H may be excluded while retaining the presumption of conformity. Refer to Table 1. It should be noted that where the exclusions described in sub-clause 1.2 of EN ISO 9001:2000 are exceeded, conformity to EN ISO 9001:2000 shall not be claimed. Table 2 and Table 3 are provided below to help companies identify similarities and differences between ISO 9001 (1994) and international standard ISO 9001:2000, respectively. Table 2 is provided to help the readers of the manual understand the basic changes and the correspondence between ISO 9001:1994 and ISO 9001:2000. Table 3 provides correspondence between the ISO 9001:2000 and ISO 9001:1994.
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Table 1 Module D Permissible Exclusions
Module E Permissible Exclusions
Sub-clause 7.1: planning of product realization Sub-clause 7.2.3: customer communication Sub-clause 7.3: design and development Sub-clause 7.4: purchasing Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of processes for production and service provision Sub-clause 7.5.3: identification and traceability
Sub-clause 7.3: design and/or development
Module H Permissible Exclusions
No exclusions permitted
It should be noted that no explicit requirements in modules H, D, and E relate to the concepts of “customer satisfaction” and “continual improvement.” As a consequence, noncompliance with requirements of EN ISO 9001:2000, explicity related to these concepts, does not infringe upon the presumption of conformity to the appropriate module. Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI under licence number 2001SK/0060. Complete standards can be obtained by post from BSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0) 20 8996 9001).
Table 2 ISO 9001:1994
1.0 2.0 3.0 4.0 4.1 4.1.1 4.1.2
Scope Normative reference Definitions Quality system requirements (title only) Management responsibility (title only) Quality policy Organization (title only)
ISO 9001:2000
1.0 2.0 3.0
5.1 + 5.3 + 5.4.1
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Table 2 (Continued) ISO 9001:1994
ISO 9001:2000
4.1.2.1 4.1.2.2 4.1.2.3 4.1.3 4.2 4.2.1
Responsibility and authority Resources Management representative Management review Quality system (title) General
5.5.1 5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.2.2 4.2.3 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.4 4.4.1 4.4.2 4.4.3
Quality system procedures Quality planning Contract review (title only) General Review Amendment to a contract Records Design control (title only) General Design and development planning Organizational and technical interfaces Design input Design output Design review Design verification Design validation Design changes Document and data control (title only) General Document and data approval and issue Document and data changes Purchasing (title only) General Evaluation of subcontractors Purchasing data Verification of purchased product Control of customer-supplied product
4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.7
4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 4.2.1 5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.2.2 7.2.2
7.3.1 7.3.1 7.2.1 7.3.3 7.3.1 7.3.1 7.3.1 7.3.7
+ 7.3.2 + 7.3.4 + 7.3.5 + 7.3.6
4.2.1 + 4.2.3 4.2.3 4.2.3
7.4.1 7.4.2 7.4.3 7.5.4
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Table 2 (Continued) ISO 9001:1994
4.8 4.9 4.10 4.10.1 4.10.2 4.10.3 4.10.4 4.10.5 4.11 4.11.1 4.11.2 4.12 4.13 4.13.1 4.13.2 4.14 4.14.1 4.14.2 4.14.3 4.15
4.15.1 4.15.2 4.15.3 4.15.4 4.15.5 4.15.6 4.16 4.17 4.18 4.19 4.20
Product identification and traceability Process control Inspection and testing (title only) General Receiving inspection and testing In-process inspection and testing Final inspection and testing Inspection and test records Control of inspection, measuring, and test equipment (title only) General Control procedure Inspection and test status Control of nonconforming product (title only) General Review and dispositioning of nonconforming product Corrective and preventive action (title only) General Corrective action Preventive action Handling, storage, packaging, preservation, and delivery (title only) General Handling Storage Packaging Preservation Delivery Control of quality records Internal quality audits Training Servicing Statistical techniques (title only)
ISO 9001:2000
7.5.3 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 7.1 + 8.1 7.4.3 + 8.2.4 7.4.3 + 7.5.1 + 8.2.4 7.4.3 + 8.2.4 7.5.3 + 8.2.4
7.6 7.6 7.5.3
8.3 8.3
8.5.2 + 8.5.3 8.4 + 8.5.2 8.4 + 8.5.3
7.5.5 7.5.5 7.5.5 7.5.5 7.5.1 + 7.5.5 4.2.4 8.2.2 + 8.2.3 6.2.1 + 6.2.2 7.1 + 7.5.1
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Table 2 (Continued) ISO 9001:1994
4.20.1 4.20.2
Identification of need Procedures
ISO 9001:2000
8.1 + 8.2.3 + 8.2.4 + 8.4
Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI under licence number 2001SK/0060. Complete standards can be obtained by post from BSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0) 20 8996 9001).
Table 3 ISO 9001:2000
1.0 1.1 1.2 2.0 3.0 4.0 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 5.0 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3
Scope General Application Normative reference Terms and definitions Quality management system (title only) General requirements Documentation requirements (title only) General Quality manual Control of documents Control of quality records Management responsibility (title only) Management commitment Customer focus Quality policy Planning (title only) Quality objectives Quality management system planning Responsibility, authority, and communication (title only) Responsibility and authority Management representative Internal communication
ISO 9001:1994
1.0
2.0 3.0
4.2.1
4.2.1 + 4.5.1 4.2.1 4.5.1 + 4.5.2 + 4.5.3 4.16
4.1 + 4.1.2.2 + 4.2.1 4.3.2 4.1.1 4.1.1 + 4.2.1 4.2.3
4.1.2.1 4.1.2.3
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Table 3 (Continued) ISO 9001:2000
5.6 5.6.1 5.6.2 5.6.3 6.0 6.1 6.2 6.2.1 6.2.2 6.3 6.4 7.0 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1
Management review (title only) General Review input Review output Resource management (title only) Provision of resources Human resources (title only) General Competence, awareness, and training Infrastructure Work environment Product realization (title only) Planning of product realization Customer-related processes (title only) Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development (title only) Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing (title only) Purchasing process Purchasing information Verification of purchased product Production and service provision (title only) Control of production and service provision
ISO 9001:1994
4.1.3 4.1.3 4.1.3 4.1.3 4.1.2.2 4.1.2.2 + 4.2.3 + 4.18 4.18 4.1.2.2 + 4.9 4.9 4.2.3 + 4.9 + 4.10.1
4.3.2 + 4.3.3 + 4.3.4 4.3.2 + 4.3.3 + 4.3.4 4.3.2 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9
4.6.2 4.6.3 4.6.4 + 4.10.2 + 4.10.3 + 4.10.4
4.9 + 4.10.3 + 4.15.6 + 4.19
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Table 3 (Continued) ISO 9001:2000
7.5.2 7.5.3 7.5.4 7.5.5 7.6 8.0 8.1 8.2 8.2.1 8.2.2 8.2.3 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3
Validation of processes of production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis, and improvement (title only) General Monitoring and measurement (title only) Customer satisfaction Internal audit Monitoring and measurement of processes Control of nonconforming product Analysis of data Improvement (title only) Continual improvement Corrective action Preventive action
ISO 9001:1994
4.9 4.8 + 4.10.5 + 4.12 4.7 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 + 4.15.6 4.11.1 + 4.11.2
4.10 + 4.17 + 4.20.1
4.17 4.9 + 4.17 + 4.20.1 4.13.1 + 4.13.2 4.14.2 + 4.14.3 + 4.20 4.1.3 4.14.1 + 4.14.2 4.14.1 + 4.14.3
Extracts from BS EN ISO 9001:2000 reproduced with permission of BSI under licence number 2001SK/0060. Complete standards can be obtained by post from BSI Customer Services, 389 Chiswick High Road, London W 4 4AL. (Tel +44 (0) 20 8996 9001).
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100.10.3
THE BASIC CHANGES The third edition of ISO 9001 cancels and replaces the second edition of ISO 9001:1994 together with ISO 9002:1994 and ISO 9003:1994. Those organizations that have used ISO 9002:1994 and ISO 9003:1994 in the past may use this revised international standard by excluding certain requirements in accordance with clause 1.2. The revised and adopted module ISO 9001:2000 makes the quality system management requirements extremely clear. The review of Tables 1 and 2, under the heading “Correspondence between ISO 9001 (1994) and ISO 9001:2000,” reveals that the same processes are specified in both standards, even though they have dif ferent names and subheadings. The quality system requirements in ISO 9001:2000 are comprehensively grouped under clause 7 with additional emphasis on customer satisfaction and internal communication. Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to the requirements within clause 7. Such exclusions do not affect the organization’s ability or responsibility to provide products that fulfill customer and applicable regulatory requirements. The quality management principles stated in ISO 9004 were taken into consideration during the development of this international standard. This standard promotes the adoption of a process appropriate when developing, implementing, and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements. The following eight management principles are integrated into the ISO 9001:1994 standard and revised as the third edition of ISO 9001:2000.
Customer satisfaction Role of leadership Involvement of employees The business process approach Systematic approach to management Continual improvement A factual approach to decision making Mutually beneficial relationship with supplier
It is important for an organization to understand current and future needs and expectations, as well as quantify customer satisfaction and act on it. Those in positions of leadership should deploy policies and verifiable objectives, establish vision, and give direction to shared values. Management should set challenging goals and implement strategies to
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achieve those goals, as well as empower qualified employees with a documented system. The standards emphasize creating personal ownership of an organization’s goals by using the experience and knowledge of qualifi ed and trained personnel with identified authority and responsibility to continuously work toward process improvement. A system should be established for the identification of internal and external customers and suppliers of processes. Process activities should be focused to adequately use the personnel, materials, machines, and methods to demonstrate control. All processes within a system should be identified and aligned for their interdependency with measurable organization goals and objectives. Continuous improvement should be ensured with realistic and challenging goals, and adequate resources should be provided to meet the company’s needs in terms of people and equipment to accomplish customer requirements. Continual improvement should be ensured through management services, internal/external audits, and corrective and preventive actions. The analysis of data and information such as customer complaints, nonconfor ming products, and audits should be conducted on continuous basis to enhance productivity and minimize waste rework and rejections. Cost improvement projects should be implemented. Efforts should be made to establish strategic alliances and to ensure joint development and the continuous improvement of products, processes, and systems. The company should ensure thorough review and evaluation of the performance of subcontractors in order to meet customer requirements. ISO 9000 defines system processes as activities that use resources to transform input into output. Inputs to a process are often outputs from other processes. Any activity or operation that receives inputs and converts them to outputs can be considered a process. Almost all product and/or service activities and operations are processes. For organizations to function, they have to define and manage numerous linked processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the “process approach” to management. The proposed new version of the international standard encourages the adoption of the process approach for both the management of the organization and its processes and as a means of readily identifying and managing opportunities for customer satisfaction with continuous improvement.
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DOCUMENTATION AND REGISTRATION/CERTIFICATION ISO 9001:2000 registrants are familiar with the phrase “quality manual and standard operating procedures.” A company cannot comply with registration requirements if there is no approved quality manual/standard operating procedures/working formats and records. The quality manual documentation should be completed by the top management to ensure commitment at all the appropriate levels within the organization. The quality policy, goals, and objectives defined in the quality manual must be verifiable. The applicable procedures should be established and documented by the company prior to the certification process. Normally, the development of a quality manual and applicable procedures is the most time-consuming factor, and the time may vary from small to large organizations. However, documentation time can be greatly reduced using these sample quality manuals and standard operating procedures. Users should go through this text and review their current systems in order to incorporate changes in these electronic files, which may take 4 to 12 weeks. It is expected that the documented quality standards will be in place and implemented at least three months prior to the registration audit. For the documentation development process, refer to Figure 1. Figure 2 provides guidelines for the registration/certification process, which is self-explanatory. Figure 3 provides an ISO 9001:2000 documentation and certification time line.
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ISO 9001:2000 Document Development Compliance Manual
Review international standard ISO 9000 Series Development Manual Review ISO 9001:2000 international standard Review customer and statutory requirements applicable to your operations
Amend electronic files provided on CD-ROM to incorporate change as per the company’s operations
Provide training
Systems implemented minimum 3 months
Perform audit
Conduct management review
Contact certification body, local office
Figure 1 The documentation development process.
27
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Certification body contacted
Questionnaire completed and returned with application forms
Pre-assessment (optional)
Desk study by certification body
Documentation amendment if necessary No Recommended or approved Yes Recommended, approved
Surveillance every six months
Figure 2 The assessment process.
Corrective action
Reassessment
100.10.4
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ISO 9001:2000 Document Development Compliance Manual
Task
Responsibility
Company audit questioner Preparation of quality manual (QM) Finalization of quality manual (QM) Preparation of SOPs (20) Training of staff
ABC Company
1st
2nd
3rd
Month 4th 5th
ABC Company ABC Company ABC Company ABC Company
Implementation of procedure Management review
ABC Company ABC Company
Internal audit
ABC Company
Training of lead auditors Pre-inspection by certification body Final inspection by certification body
ABC Company ABC Company ABC Company
Figure 3 ISO 9001:2000 documentation and certification schedule.
6th
7th
29
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200.20.1
YOUR COMPANY NAME HERE QUALITY ASSURANCE DEPARTMENT QUALITY SYSTEMS MANUAL MODEL - 1 PREPARED AND MAINTAINED IN ACCORDANCE WITH ISO 9001:2000 Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-1
DISTRIBUTED TO 1) Managing Director 2) Quality Assurance 3) Marketing 4) ISO Management Representative 5) 6)
Revision No: 0 CONTROLLED COPY NO. Copy-1 Copy-2 Copy-3 Master
Reasons for Revision: mm/dd/yy 1) First time issued for (your company name).
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TABLE OF CONTENTS QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000 Contents Quality Management Systems Requirement (title only) . . . Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Normative Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . Terms and Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Management System (title only) . . . . . . . . . . . . . . General Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . Documentation Requirements (title only) . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control of Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . Control of Quality Records. . . . . . . . . . . . . . . . . . . . . . . . Management Responsibility (title only) . . . . . . . . . . . . . . . Management Commitment . . . . . . . . . . . . . . . . . . . . . . . . Customer Focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Planning (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Management System Planning . . . . . . . . . . . . . . . Responsibility, Authority, and Communication (title only) . Responsibility and Authority. . . . . . . . . . . . . . . . . . . . . . . Management Representative . . . . . . . . . . . . . . . . . . . . . . . Internal Communication . . . . . . . . . . . . . . . . . . . . . . . . . . Management Review (title only) . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Review Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Review Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Resource Management (title only). . . . . . . . . . . . . . . . . . . Provision of Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . Human Resources (title only) . . . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competence, Awareness, and Training . . . . . . . . . . . . . . .
Clauses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.... . .1.0 . .1.1 . .1.2 . .2.0 . .3.0 . .4.0 . .4.1 . .4.2 4.2.1 4.2.2 4.2.3 4.2.4 . .5.0 . .5.1 . .5.2 . .5.3 . .5.4 5.4.1 5.4.2 . .5.5 5.5.1 5.5.2 5.5.3 . .5.6 5.6.1 5.6.2 5.6.3 . .6.0 . .6.1 . .6.2 6.2.1 6.2.2
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Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Work Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product Realization (title only) . . . . . . . . . . . . . . . . . . . . . . . Planning of Product Realization . . . . . . . . . . . . . . . . . . . . . . Customer-Related Processes (title only). . . . . . . . . . . . . . . . . Determination of Requirements Related to the Product. . . . . Review of Requirements Related to the Product . . . . . . . . . . Customer Communication . . . . . . . . . . . . . . . . . . . . . . . . . . Design and Development (title only) . . . . . . . . . . . . . . . . . . Design and Development Planning . . . . . . . . . . . . . . . . . . . Design and Development Inputs . . . . . . . . . . . . . . . . . . . . . Design and Development Outputs . . . . . . . . . . . . . . . . . . . . Design and Development Review. . . . . . . . . . . . . . . . . . . . . Design and Development Verification. . . . . . . . . . . . . . . . . . Design and Development Validation. . . . . . . . . . . . . . . . . . . Control of Design and Development Changes . . . . . . . . . . . Purchasing (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purchasing Process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purchasing Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . Verification of Purchased Product . . . . . . . . . . . . . . . . . . . . . Production and Service Provision (title only) . . . . . . . . . . . . Control of Production and Service Provision . . . . . . . . . . . . Validation of Processes for Production and Service Provision Identification and Tracebility . . . . . . . . . . . . . . . . . . . . . . . . Customer Property . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preservation of Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . Control of Monitoring and Measuring Devices . . . . . . . . . . . Measurement, Analysis, and Improvement (title only) . . . . . . General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitoring and Measurement (title only) . . . . . . . . . . . . . . . Customer Satisfaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Internal Audit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Monitoring and Measurement of Processes . . . . . . . . . . . . . . Monitoring and Measurement of Product . . . . . . . . . . . . . . . Control of Nonconforming Product . . . . . . . . . . . . . . . . . . . Analysis of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Improvement (title only) . . . . . . . . . . . . . . . . . . . . . . . . . . . Continual Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . Corrective Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preventive Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix I (Reference SOPs)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
200.20.1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. .6.3 . .6.4 . .7.0 . .7.1 . .7.2 7.2.1 7.2.2 7.2.3 . .7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 . .7.4 7.4.1 7.4.2 7.4.3 . .7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 . .7.6 . .8.0 . .8.1 . .8.2 8.2.1 8.2.2 8.2.3 8.2.4 . .8.3 . .8.4 . .8.5 8.5.1 8.5.2 8.5.3
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SCOPE Correspondence clause of ISO 9001:2000 Written by:
Clause — 1.0 ISO 9001:1994 1.0 + 1.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SCOPE The quality system manual is applicable to (company name) products, activities, and services and includes design manufacture and final product inspection and testing.
GENERAL The ISO 9001:2000 international standard adopted by (company name) specifies requirements for a quality management system to demonstrate the ability to consistently provide products that meet customer satisfaction and applicable regulatory requirements. The objective is to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system. In this quality system manual, the term “product” applies only to the product intended for, or required by, a customer. It should be noted that no exclusion is permitted in the adopted model.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL APPLICATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 1.0 ISO 9001:1994 1.2
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APPLICATION The requirements of ISO 9001:2000 international standards are generic and are applicable to all the departments of (company name), their size, nature of their operation, and the product or product part manufactured. Where any requirement (s) of this international standard cannot be applied due to the operations of (company name), its products are excluded. Claims of conformity to this international standard where exclusions are made are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability or responsibility to provide products that fulfill our customers’ and applicable regulatory requirements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL NORMATIVE REFERENCE Correspondence clause of ISO 9001:2000 Written by:
Clause — 2.0 ISO 9001:1994 2.0
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NORMATIVE REFERENCE The quality system manual contains provisions of the international standard ISO 9001:2000 and ISO 9001 (1994).
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TERMS AND DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
Clause — 3.0 ISO 9001:1994 3.0
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TERMS AND DEFINITIONS The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed in the quality system manual and applicable standard operating procedure to reflect the vocabulary currently used. The term “organization” is replaced by the term “supplier” used in ISO 9001:1994 and refers to the unit to which this international standard applies. Also, the term “supplier” is replaced by the term “subcontractor.” Throughout the text of this quality system manual and applicable procedure, the term “product” also means “service.” For the purposes of this international standard ISO 9001:2000, the terms and definitions given in ISO 9000 are applicable.
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Analysis Certificate The analysis certificate is the document that gives the results of the inspection made on a representative sample taken from a product before its delivery. It must contain the results of all checks in a list approved jointly by the client and the supplier.
Auditor A person who is qualified and authorized to perform all or any portion of a quality system audit is an auditor.
Audit An audit is a systematic and independent examination to deter mine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives.
Audit Organization An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard.
Batch A batch represents assignments of a batch of finished products to a client as a function of that client’s requirements.
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Clause — 3.0 ISO 9001:1994 3.0
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Conformity Conformity means the state of a product satisfying specified requirements.
Documentation Documentation refers to any recorded or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Documentation Level The documentation level refers to the position of a quality document in the quality assurance documentation system.
First Party Audits Audits carried out internally by an organization are called first party audits.
Inspection An inspection is an examination or measurement to verify whether an item or activity conforms to a specified requirement.
Inspectors Inspectors are appointed by the purchaser to provide advice on matters relating to products and inspection and to verify the achievement of the quality specified.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TERMS AND DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
Clause — 3.0 ISO 9001:1994 3.0
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Lead Auditor An Auditor who is qualified and authorized to manage a quality system audit is called a lead auditor.
Management Review Management review is a compulsory evaluation carried out by general management on the state and suitability of the quality system with respect to quality policy and new objectives resulting from the changed situation.
Nonconformity Nonconformity refers to the state of a product not satisfying specified requirements.
Organization An organization is a unit to which this international standard applies.
Provisional Auditor A provisional auditor is a person who meets all requirements for registration except for audit experience.
Quality Quality means all properties and characteristics of a service that make it capable of satisfying a client’s expressed or specified needs.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TERMS AND DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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Quality Audit A quality audit is a methodical and independent examination in order to determine if quality-related activities and results satisfy predetermined requirements, and if these requirements are implemented efficiently and are capable of achieving the objectives.
Quality Assurance Quality assurance refers to all predetermined and systematic actions necessary to give appropriate confidence that a product or a service satisfies given quality requirements.
Quality Control Quality control is that part of good manufacturing practice concerned with sampling, specifications, and testing. Its organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out, that materials are not released for use and products released for sale or supply, until their quality has been judged to be satisfactory.
Quality Manual The quality manual is a document describing general measures taken by the company to obtain quality in its products or services.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TERMS AND DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
Clause — 3.0 ISO 9001:1994 3.0
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Quality Planning A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be referred to as quality plan.
Quality Policy A quality policy includes the overall quality intentions and direction of an organization as formally expressed by top management.
Quality (or Quality-Related) Record The quality record refers to the filled-in documents proving that the quality assurance and quality control actions have been done.
Quality System The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management comprise the quality system.
Quality Surveillance Quality surveillance refers to the continued monitoring and verification of the status of procedures, methods, conditions, processes, products and services, and analysis of records in relation to stated references to ensure that specified requirements for quality are being met.
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Clause — 3.0 ISO 9001:1994 3.0
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Representative Sample A representative sample is a sample taken using a clearly defined procedure in order to obtain information about a batch.
Second Party Audits Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of products by one company from another within the same group.
Specification The specification is the document that specifies the requirements with which the product and/or material must comply.
Supplier The organization or company is also called the supplier.
Subcontractor Any organization offering goods or services to the supplier is known as a subcontractor.
Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are called third party audits.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TERMS AND DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
Clause — 3.0 ISO 9001:1994 3.0
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Traceability Traceability is the capability of finding the history, use, or location of an article by means of a recorded identification.
Validation Validation is the act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produced a valid result.
Verification The act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services or documents conform to specified requirements is known as verification. This list is not conclusive as there are many other terms in general use or contained in various standards and quality documents.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.2.1 ISO 9001:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
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QUALITY MANAGEMENT SYSTEM The quality management system is based on inter national standard ISO 9001:2000, which can be effectively applied to (company name) products, activities, and processes.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL GENERAL REQUIREMENTS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2.1 ISO 9001:1994 4.1
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GENERAL REQUIREMENTS (Company name) has established, documented, implemented, and maintained a quality management system and continually improved its effectiveness in accordance with the requirements of this international standard. The organization has identified the process needed for the quality management system and its application throughout the organization, and has determined the sequence and interaction of these processes as well as criteria and methods needed to ensure that both the operation and control of these processes are effective. The top management has ensured the availability of resources and information necessary to support the operation and the monitoring of these processes, and has implemented the actions necessary to achieve the desired results and continual improvement of these processes. These processes, including management activities, pr ovision of resources, product realization, and measurement, are managed by the organization in accordance with the requirements of this international standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization ensures control over such process. Control of such outsource processes is identified within the quality management system.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENTATION REQUIREMENTS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2.1 + 4.5.1 Revision 0 ISO 9001:1994 4.2 Checked by:
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DOCUMENTATION REQUIREMENTS The documentation requirements are fulfilled in accordance with international standard ISO 9001:2000. The documentation includes information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL GENERAL Correspondence clause of ISO 9001:2000 Written by:
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GENERAL The documented quality management system is comprised of the following key documents, but is not limited to these components:
Quality policy and quality objectives Quality system manual Procedures required by this international standard Documents needed by the organization to ensure the effective planning, operation, and control of its processes Quality records required by this international standard (see 4.2.4) Documentation maintained in both hardware and software form as appropriate
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANUAL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2.1 ISO 9001:1994 4.2.2
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QUALITY MANUAL (Company name) has established and maintained a quality system manual to describe the scope of its quality management system, including details of and justification for any exclusions (see 1.2). The documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management system are included. The need to achieve quality in activities, services, and products has been recognized to ensure that the organization meets well-defined objectives, satisfies its users/customers expectations and contractual requirements, complies with applicable standards and specifications, and provides value for money.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF DOCUMENTS
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5.1 + 4.5.2 + 4.5.3 ISO 9001:1994 4.2.3
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CONTROL OF DOCUMENTS Procedures and documents required by the quality management system are controlled. Quality records are a special type of document and are controlled according to the requirements given in 4.2.4 The applicable documented procedure is established to define the controls needed, to approve documents for adequacy prior to issue, to review and update as necessary and reapprove documents, and to ensure that changes and the current revision status of documents are identified. It is ensured that relevant versions of applicable documents are available at points of use as appropriate, and remain legible and readily identifiable. The documents of external origin are identified, and their distribution is controlled to prevent the unintended use of obsolete documents and to apply suitable identification to them if they are withheld for any purpose.
Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF QUALTY RECORDS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.8 ISO 9001:1994 4.2.4
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CONTROL OF QUALITY RECORDS Quality records are identified, established, and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are legible, readily identifiable, and retrievable for quality records. A procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT RESPONSIBILITY
Correspondence clause of ISO 9001:2000 Written by:
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MANAGEMENT RESPONSIBILITY Management responsibilities are defined in correspondence with international standard ISO 9001:2000 to assist the management team in achieving its quality aims, promote a reputation in the marketplace through customer satisfaction, motivate staff toward pride in carrying out a job, and identify control training needs, improve communication, and produce historical records to confirm the level of quality system effectiveness and activity/service/product achievement. Management responsibilities are defined in the following quality matrix Table 1. Individual companies can tailor this table according to their specific setup.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT RESPONSIBILITY
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1 + 4.1.2.2 + 4.2.1 ISO 9001:1994 5.0
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The quality planning matrix is described in Table 1. Table 1 Corresponding Clause ISO 9001:2000
ISO-9001:1994 CLAUSE
4.1
Management responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control
4.5
Document and data control
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
5.1 + 5.3 + 5.4.1 + 5.5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 5.4.2 + 6.2.1 + 7.1 5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.3.1 7.2.1 + 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 4.2.1 + 4.2.3
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * – – – – * X * * * – * – – – X * – * –
* * * * * * * X * * * *
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT RESPONSIBILITY
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1 + 4.1.2.2 + 4.2.1 ISO 9001:1994 5.0
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Table 1 (Continued) Corresponding Clause ISO 9001:2000
ISO-9001:1994 CLAUSE
4.6
Purchasing
4.7
Control of customersupplied product Product identification and traceability Process control
4.8
4.9
4.10
Inspection and testing
4.11
Inspection, measurement, and test equipment Inspection and test status
4.12
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.4.1 7.4.2 7.4.3 7.5.4
* * – * * – – * X – – *
7.5.3
* * X * * – – * * * * *
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 7.1 + 8.1 7.4.3 + 8.2.4 7.5.1 7.5.3 7.6
– * X * – – – * – * – –
7.5.3
– X * * – – – * – * – –
– X – * – – – – – – – –
– X * * – – – – – * – –
– * * * – X – * – * – –
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT RESPONSIBILITY
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1 + 4.1.2.2 + 4.2.1 ISO 9001:1994 5.0
Revision 0
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Table 1 (Continued) Corresponding Clause ISO 9001:2000
ISO-9001:1994 CLAUSE
4.13
4.14 4.15
4.16 4.17 4.18 4.19 4.20
Control of nonconforming product Corrective actions Handling, storage, packaging, preservation, and delivery Quality records Internal quality audits Training Servicing Statistical techniques
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
8.3
* * * X * * – * * * * *
8.5.2 + 8.5.3 8.4 7.5.5 + 7.5.1
* X * * * * * * * * * *
– * * * * – – – – * – X 4.2.4 8.2.2 + 8.2.3
* * * X * * * * * * * * * X * * * * – * * * * *
6.2.1 + 6.2.2 7.1 + 7.5.1 8.1 + 8.2.3 + 8.2.4 + 8.4
* X * * * * X * * * * * * * * * * – – * * * X * * X * * – – – – – * – –
X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, – NOT APPLICABLE Key: ADM PRD SHP PDL PAC MPM
= = = = = =
Administration (Management) Production Shipping Product Development Lab Packaging Materials Planning Manager
QUA QCD PER PUR MKT MAI
= = = = = =
Quality Assurance Quality Control Department Personnel Purchase Marketing Maintenance
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT COMMITMENT
Correspondence clause of ISO 9001:2000 Written by:
Revision 0
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MANAGEMENT COMMITMENT (Company name) has provided objective evidence of its commitment to developing and implementing the quality management system, continually improving its effectiveness through communicating to the organization the importance of meeting customer as well as statutory and r egulatory requirements, and establishing the quality policy and ensuring that quality objectives are established. Adequate resources are provided and management reviews are conducted at specified frequencies.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER FOCUS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3.2 ISO 9001:1994 5.2
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CUSTOMER FOCUS The organization has ensured that customer requirements are identified and has met the acceptance criteria to achieve customer satisfaction (see 7.2.1 and 8.2.1) The documented quality system is maintained to ensure that the product conforms to the specified requirements and meets the expectations and needs of the user, and that the product is continuously maintained to the prescribed standard, specification, contract, and order agreement.
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY POLICY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1 ISO 9001:1994 5.3
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QUALITY POLICY (Company name) has established the quality policy, which is appropriate to the purpose of the organization with a commitment to comply with requirements and continually improve the effectiveness of the quality management system. The quality policy provides a management commitment for establishing and reviewing quality objectives. The policy is communicated and understood within the organization and is reviewed on a periodic basis for its suitability.
(COMPANY NAME) POLICY The organization will comply with the provisions of the current good manufacturing practice (CGMP) for the fi nished pharmaceutical as described in Code 210 of the Federal Regulation — Curr ent Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs. Signature and Date (Top Management)
ORGANIZATION CHART HERE
Describe a brief history of the company Key positions summary Location and number of employees Brief responsibility of key personnel Products, services, and activities offered Organization chart
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PLANNING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1 + 4.2.1 Revision 0 ISO 9001:1994 5.4 Checked by:
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PLANNING (Company name) has ensured customer satisfaction while meeting regulatory requirements through effective planning at all levels.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY OBJECTIVES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1 + 4.2.1 Revision 0 ISO 9001:1994 5.4.1 Checked by:
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QUALITY OBJECTIVES Our organization has established the quality objectives, including those needed to meet requirements for the product (see 7.1 a), relevant functions, and levels within the company. The quality objectives are quantifiable and consistent with the quality policy.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.2.3 PLANNING ISO 9001:1994 Correspondence clause of 5.4.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
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QUALITY MANAGEMENT SYSTEM PLANNING Our organization has ensured that planning of the quality management system is carried out to meet the requirements given in 4.1, as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality management system ar e planned and implemented.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESPONSIBILITY, AUTHORITY, Clause — 4.1.2.1 AND COMMUNICATION ISO 9001:1994 Correspondence clause of 5.5 ISO 9001:2000 Written by: Checked by: Date Supersedes
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RESPONSIBILITY, AUTHORITY, AND COMMUNICATION Communication is conducted through identification of job responsibilities, training, and awareness.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESPONSIBILITY AND AUTHORITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.1 ISO 9001:1994 5.5.1
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RESPONSIBILITY AND AUTHORITY Top management has ensured that the responsibilities and authorities are defined and communicated within the organization. The interrelations and overlapping responsibilities are also communicated.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REPRESENTATIVE Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.3 ISO 9001:1994 5.5.2
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MANAGEMENT REPRESENTATIVE (Company name) has exclusively appointed a management representative who, irrespective of other responsibilities, has the responsibility and authority that includes: Identifying processes and implementing and maintaining the quality management system needed for quality management Evaluating and reporting the performance of the quality management system and the needs for improvement Creating the promotion of awareness of customer requirements throughout the organization
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTERNAL COMMUNICATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.3 ISO 9001:1994 5.5.3
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INTERNAL COMMUNICATION Appropriate communication procedures are established within the organization and are communicated regarding the effectiveness of the quality management system.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 5.6
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MANAGEMENT REVIEW Management review provides an effective tool for company management to review the effectiveness of the existing quality system.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL GENERAL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 5.6.1
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GENERAL Our top management reviews the organization’s quality management system every quarter-year to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records of the management reviews are maintained (see 4.2.4).
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REVIEW INPUT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 5.6.2
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REVIEW INPUT The input for the management review includes exorbitant information including, but not limited to:
Recommendations for improvement Planned changes that could affect the quality management system Status of preventive and corrective action Follow-up actions from previous management reviews Process performance and product conformity Customer feedback Results of audits
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REVIEW OUTPUT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 5.6.3
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REVIEW OUTPUT The output from the management reviews include decisions and actions related to improvement of the effectiveness of the quality management system and its processes, improvement of the product related to customer requirements, and resource needs.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESOURCE MANAGEMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1.2 ISO 9001:1994 6.0
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RESOURCE MANAGEMENT Adequate resources are managed to achieve the management objectives, customer satisfaction, and product compliance.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROVISION OF RESOURCES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1.2 ISO 9001:1994 6.1
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PROVISION OF RESOURCES Our organization has determined and provided the necessary resources needed to implement and maintain the quality management system and continually improve its effectiveness, and to enhance customer satisfaction by meeting customer requirements.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL HUMAN RESOURCES
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1.2 + 4.2.3 + 4.16 ISO 9001:1994 6.2
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HUMAN RESOURCES The organization of planned human resources plays an important role in the effectiveness of the quality system. The records of human resource development are documented and maintained.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.16, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL GENERAL
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1.2 + 4.2.3 + 4.16 ISO 9001:1994 6.2.1
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GENERAL Employees performing work affecting product quality are competent on the basis of appropriate education, training, skills, and background experience.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL COMPETENCE, AWARENESS, AND TRAINING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.16 ISO 9001:1994 6.2.2
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COMPETENCE, AWARENESS, AND TRAINING (Company name) has determined the necessary competence for personnel performing work affecting product quality, has provided training, or has taken other action to satisfy these needs. Effectiveness of the actions taken is evaluated, and it is ensured that the employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. Records of education, training, skills, and experience are appropriately maintained (see 4.2.4).
Reference Procedure — [Number ISO-4.16, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INFRASTRUCTURE Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.2 + 4.9 Revision 0 ISO 9001:1994 6.3 Checked by:
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INFRASTRUCTURE (Company name) has determined, established, and maintained the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, but is not limited to, buildings, workspace, and associated utilities. Process equipment, both hardware and software, and supporting services such as transport or communication are reviewed and established on a continuous basis.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL WORK ENVIRONMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 ISO 9001:1994 6.4
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WORK ENVIRONMENT Top management has determined and managed the work environment necessary to achieve conformity to product requirements such as temperature, humidity, etc.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRODUCT REALIZATION
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2.3 + 4.9 + 4.10.1 ISO 9001:1994 7.0
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PRODUCT REALIZATION Product realization is achieved through effective planning to achieve product requirements and quality objectives.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PLANNING OF PRODUCT REALIZATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2.3 + 4.9 + 4.10.1 ISO 9001:1994 7.1
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PLANNING OF PRODUCT REALIZATION Top management plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the following elements are determined appropriate: Quality objectives and product requirements Processes establishment, documents, and provision of resources specific to the product Verification, validation, monitoring, inspection, and test activities specific to the product to fulfill requirements (see 4.2.4) Records needed to provide evidence that the realization processes and resulting product fulfill requirements (see 4.2.4) The output of this planning is kept both in hardware and software form.
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER-RELATED PROCESSES Clause — 4.3.2 + 4.4.4 Revision 0 ISO 9001:1994 Correspondence clause of 7.2 ISO 9001:2000 Written by: Checked by: Approved by: Date Supersedes
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CUSTOMER-RELATED PROCESSES The organization ensures the understanding of current and future customer needs and expectations through leadership, the involvement of people, continual improvement, and a mutually beneficial relationship with the supplier.
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL Clause — 4.3.2 + 4.4.4 Revision 0 DETERMINATION OF ISO 9001:1994 REQUIREMENTS RELATED TO THE PRODUCT Correspondence clause of 7.2.1 ISO 9001:2000 Written by: Checked by: Approved by: Date Supersedes
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DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT (Company name) has determined: Customer-specified requirements, including delivery and postdelivery activities Requirements necessary for specified use or known and intended use but not stated by the customer Regulatory and statutory requirements related to the product Additional requirements determined by the organization, if any
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3.2 + 4.3.3 + 4.3.4 ISO 9001:1994 7.2.2
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REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT The organization reviews the requirements related to the product prior to the organization’s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that: Product requirements are defined Contract or order requirements differing from those previously expressed are resolved The organization has the ability to meet the defined requirements Records of the results of the review and actions arising from the review are maintained (see 4.2.4). The customer requirements are confirmed by the organization before acceptance when the customer provides no documented statement of requirement. If product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER COMMUNICATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3.2 ISO 9001:1994 7.2.3
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CUSTOMER COMMUNICATION (Company name) has established and implemented effective arrangements for communicating with customers in relation to: Product information Inquiries, contracts, or order handling, including amendments Customer feedback, including customer complaints
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8 ISO 9001:1994 7.3
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DESIGN AND DEVELOPMENT Design and development are carried out through effective quality planning. Both products and services are considered, with particular reference to customer focus.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT PLANNING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8 ISO 9001:1994 7.3.1
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DESIGN AND DEVELOPMENT PLANNING The design and development of the product is controlled, and the design and development stages are defined. The review, verification, and validation that are appropriate to each design and development stage, and the responsibilities and authorities for design and development are clearly defined and assigned. The interfaces between different groups involved in design and development are managed to ensure effective communication and clear assignment of responsibility. Planning output is updated, as appropriate, as the design and development progress.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT Clause — 4.4.4 INPUTS ISO 9001:1994 Correspondence clause of 7.3.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
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DESIGN AND DEVELOPMENT INPUTS Inputs related to product requirements are determined and records are maintained (see 4.2.4) and include, but are not limited to, the following:
Functional and performance requirements Applicable statutory and regulatory requirements Information derived from previous similar designs where applicable Other requirements essential for design and development
These inputs are reviewed for adequacy. Requirements are completed to ensure they are unambiguous and not in conflict with each other.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT Clause — 4.4.5 OUTPUTS ISO 9001:1994 Correspondence clause of 7.3.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
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DESIGN AND DEVELOPMENT OUTPUTS The outputs of design and development are provided in a form that enables verification against the design and development input and are approved prior to release. Design and development outputs: Meet the input requirements for design and development Provide appropriate information for purchasing, production, and service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its safe and proper use
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT Clause — 4.4.6 REVIEW ISO 9001:1994 Correspondence clause of 7.3.4 ISO 9001:2000 Written by: Checked by: Date Supersedes
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DESIGN AND DEVELOPMENT REVIEW Systematic reviews of design and development are conducted at suitable stages. The ability of the results of design and development to fulfill requirements is evaluated to identify any problems and propose necessary actions. The representatives of functions concerned with the design and development stages participate in a review. They record the results of the review and any necessary actions that are to be taken (see 4.2.4).
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT Clause — 4.4.7 VERIFICATION ISO 9001:1994 Correspondence clause of 7.3.5 ISO 9001:2000 Written by: Checked by: Date Supersedes
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DESIGN AND DEVELOPMENT VERIFICATION Verification is performed to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions that are to be taken (see 4.2.4).
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN AND DEVELOPMENT Clause — 4.4.8 VALIDATION ISO 9001:1994 Correspondence clause of 7.3.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
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DESIGN AND DEVELOPMENT VALIDATION Design and development validation is performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Wherever practicable, validation is completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions are maintained (see 4.2.4).
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF DESIGN AND DEVELOPMENT CHANGES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4.9 ISO 9001:1994 7.3.7
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CONTROL OF DESIGN AND DEVELOPMENT CHANGES Design and development changes are identified, and records are maintained. The changes are reviewed, verified, and validated as appropriate and are approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and the delivered product. Records of the results of the review of changes and any necessary actions are maintained (see 4.2.4).
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6.2 ISO 9001:1994 7.4
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PURCHASING Quality purchasing is achieved through procurement from approved vendor sources.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING PROCESS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6.2 ISO 9001:1994 7.4.1
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PURCHASING PROCESS The company ensures that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING INFORMATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6.3 ISO 9001:1994 7.4.2
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PURCHASING INFORMATION Purchasing information is established to describe the product to be purchased, including, where appropriate: Requirements for the approval of the product, procedures, processes, and equipment Requirements for the qualification of personnel and quality management system requirements The organization ensures the adequacy of specified purchase requirements prior to their communication to the supplier.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL VERIFICATION OF PURCHASED PRODUCT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6.4 + 4.10.2 + 4.10.3 + 4.10.4 ISO 9001:1994 7.4.3
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VERIFICATION OF PURCHASED PRODUCT (Company name) has established and implemented the inspection or other activities necessary for ensuring that the purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier premises, the organization states the intended verification arrangements and method of product release in the purchasing information.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRODUCTION AND SERVICE PROVISION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 + 4.103 + 4.15.6 + 4.19 ISO 9001:1994 7.5
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PRODUCTION AND SERVICE PROVISION (Company name) carried out production and service provisions under controlled conditions as adequate.
Reference Reference Reference Reference
Procedure Procedure Procedure Procedure
— — — —
[Number [Number [Number [Number
ISO-4.9, dated mm-dd-yyyy] ISO-4.10, dated mm-dd-yyyy] ISO-4.15, dated mm-dd-yyyy] ISO-4.19, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF PRODUCTION AND SERVICE PROVISION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 + 4.10.3 + 4.15.6 + 4.19 ISO 9001:1994 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF PRODUCTION AND SERVICE PROVISION The company has planned and carried out production and service provisions under controlled conditions as applicable, including, but not limited to, the availability of information that describes the characteristics of the product, the availability of work instructions, the use of suitable equipment, the availability and use of monitoring and measuring devices, and the implementation of monitoring and measurement, and the implementation of release, delivery, and postdelivery activities.
Reference Reference Reference Reference
Procedure Procedure Procedure Procedure
— — — —
[Number [Number [Number [Number
ISO-4.9, dated mm-dd-yyyy] ISO-4.10, dated mm-dd-yyyy] ISO-4.15, dated mm-dd-yyyy] ISO-4.19, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL VALIDATION OF PROCESSES FOR Clause — 4.9 PRODUCTION AND SERVICE ISO 9001:1994 PROVISION Correspondence clause of 7.5.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION Any process for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement, must be validated. Specific consideration is given to the processes where deficiencies become apparent only after the product is in use or the service has been delivered The planned results are achieved through validation and, where applicable, through:
Defined criteria for review and approval of the processes Approval of equipment and qualifications of personnel Use of specific methods and procedures Records (see 4.2.4) maintenance Planning and conducting revalidation
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL IDENTIFICATION AND TRACEABILITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.8 + 4.10.5 + 4.12 ISO 9001:1994 7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
IDENTIFICATION AND TRACEABILITY Where appropriate, (company name) identifies the product by suitable means throughout product realization. The product status with respect to monitoring and measurement requirements is identified. The unique identification of the product (see 4.2.4) is controlled and recorded by assigning a specific batch number to each product.
Reference Procedure — [Number ISO-4.8, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.12, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER PROPERTY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.7 ISO 9001:1994 7.5.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER PROPERTY The company identifies, verifies, protects, and safeguards customer property provided for use or incorporation into the product, including intellectual property. If any customer property is lost, damaged, or otherwise found to be unsuitable for use, that is reported to the customer and records are maintained (see 4.2.4).
Reference Procedure — [Number ISO-4.7, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRESERVATION OF PRODUCT
Correspondence clause of ISO 9001:2000 Written by:
Revision 0
Clause — 4.15.2 + 4.15.3 + 4.15.4 + 4.15.5 + 4.15.6 ISO 9001:1994 7.5.5 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRESERVATION OF PRODUCT The conformity of the product and its constituents is preserved during internal processing and delivery to the intended destination. This preservation includes identification, handling, packaging, storage, and protection.
Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF MONITORING AND MEASURING DEVICES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.11.1 + 4.11.2 ISO 9001:1994 7.6
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTROL OF MONITORING AND MEASURING DEVICES The company has established processes to ensure that monitoring and measurement necessary to be undertaken to provide evidence of product conformity to its requirements is carried out in a manner consistent with the monitoring and measurement requirements (see 7.2.1). As appropriate, measuring equipment is: Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded. Adjusted or re-adjusted where necessary Identified to enable the calibration status to be determined Protected from adjustments that would invalidate the measurement result Protected to avoid damage and deterioration during handling, maintenance, and storage In addition, when the equipment is found not to conform to requirements, the organization takes appropriate action regarding the equipment and any product affected. Records of the results of calibration and verification are maintained (see 4.2.4). The organization assesses and records the validity of the previous measuring results. The ability of computer software to satisfy the intended application is confirmed prior to initial use when used in the monitoring and measurement of specified requirements. Note: See ISO 10012-1 and ISO 10012-2 for guidance. Reference Procedure — [Number ISO-4.11, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MEASUREMENT, ANALYSIS, AND IMPROVEMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10 + 4.17 + 4.20.1 ISO 9001:1994 8.0
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MEASUREMENT, ANALYSIS, AND IMPROVEMENT The organization has ensured continual improvement in the effectiveness of the quality management system through management review (measurement and analysis), internal and external audits, and corrective actions.
Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL GENERAL
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10 + 4.17 + 4.20.1 ISO 9001:1994 8.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL The company has planned and implemented the monitoring, measurement, analysis, and improvement processes needed to demonstrated conformity of the product and has ensured conformity of the quality management system, continuity of improvement, and the effectiveness of the quality management system. This includes determination of applicable methods and statistical techniques used.
Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MONITORING AND MEASUREMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 + 4.17 + 4.20.1 ISO 9001:1994 8.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT The adequate monitoring and measurements are conducted to ensure customer satisfaction and product specification compliance.
Reference Reference Reference Reference
Procedure Procedure Procedure Procedure
— — — —
[Number-ISO-4.9, dated mm-dd-yyyy] [Number-ISO-4.10, dated mm-dd-yyyy] [Number-ISO-4.17, dated mm-dd-yyyy] [Number-ISO-4.20, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER SATISFACTION
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 + 4.17 + 4.10 ISO 9001:1994 8.2.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER SATISFACTION Suitable methods are used for obtaining information regarding customer perception as to whether the company has fulfilled customer requirements through: Internal audits Monitoring and measurement of processes Monitoring and measurement of products
Reference Procedure — [Number-ISO-4.9, dated mm-dd-yyyy] Reference Procedure — [Number-ISO-4.10, dated mm-dd-yyyy] Reference Procedure — [Number-ISO-4.17, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTERNAL AUDIT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.17 ISO 9001:1994 8.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTERNAL AUDIT (Company name) conducts internal audits at specified intervals to determine whether the quality management system: Is effectively implemented and maintained Conforms to the planned arrangements (see 7.1), the requirements of the international standards, and the quality management system requirements established by the organization Programmed audits are conducted to consider the status and importance of the processes and areas to be audited and the results of previous audits. The audit criteria, scope, frequency, and methods are defined. The selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records (see 4.2.4) are defined in a documented procedure. The management staff responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results (see 8.5.2). Note: See ISO 10011-1, ISO 10011-2, and ISO 10011-3 for guidance.
Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MONITORING AND MEASUREMENT OF PROCESSES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9 + 4.17 + 4.20.1 ISO 9001:1994 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT OF PROCESSES Suitable methods for monitoring and, where applicable, measurement of the quality management system processes are applied to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action is taken, as appropriate, to ensure conformity of the product.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MONITORING AND MEASUREMENT OF PRODUCT
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.2.1 ISO 9001:1994 8.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
MONITORING AND MEASUREMENT OF PRODUCT The product requirements are fulfilled through monitoring and measuring the characteristics of the product. Evidence of conformity with the acceptance criteria are maintained. Records indicate the person (s) authorizing release of the product (see 4.2.4). Product release and service delivery do not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, approved by the customer.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF Clause — 4.13.1 + NONCONFORMING PRODUCT 4.13.2 ISO 9001:1994 Correspondence clause of 8.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
CONTROL OF NONCONFORMING PRODUCT A product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with a nonconforming product are defined in a documented procedure. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained (see 4.2.4). When the nonconforming product is corrected, it is subjected to reverification to demonstrate conformity to the requirements. When a nonconforming product is detected after delivery or use of the product has begun, the organization takes action appropriate to the effects of the nonconformity.
Reference Procedure — [Number ISO-4.13, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL ANALYSIS OF DATA
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14.2 + 4.14.3 + 4.20 ISO 9001:1994 8.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
ANALYSIS OF DATA The data generated as a result of monitoring and measurement and from other relevant sources are analyzed to demonstrate the suitability and effectiveness of the quality management system and for continual improvement. The data is broadly based and includes, but is not limited to: Customer satisfaction (see 8.2.1) Conformance to product requirements (see 7.2.1) Characteristics and trends of processes and products, including opportunities for preventive action, and suppliers
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy] Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL IMPROVEMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 8.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
IMPROVEMENT The organization’s top management ensures continuous improvement through creating personal ownership of the organization’s goals, by using its people’s knowledge and experience, and through education achieved as a result of involvement in operational decisions and process improvement.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTINUAL IMPROVEMENT Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3 ISO 9001:1994 8.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTINUAL IMPROVEMENT The organization intends to continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CORRECTIVE ACTION
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14.1 + 4.14.2 ISO 9001:1994 8.5.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION Actions are taken to eliminate the cause of nonconformities in order to prevent recurrence. Suitable corrective actions are initiated to counter the effects of the nonconformities.
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PREVENTIVE ACTION
Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14.1 + 4.14.3 ISO 9001:1994 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PREVENTIVE ACTION A documented procedure is established to define requirements for: Determining potential nonconformities and their causes Evaluating the need for action to pr event the occurrence of nonconformities Determining and implementing actions needed Records of results of actions taken (see 4.2.4) and reviewing any preventive action taken
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy]
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APPENDIX I: Reference SOPs Subject
Quality management systems requirement (title only) Scope General Application Normative reference Terms and definitions Quality management system (title only) General requirements Documentation requirements (title only) General
Clauses
Ref. SOP No.
Revision No.
Issued On
1.0 1.1 1.2 2.0 3.0 4.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
4.1 4.2
New New New New New New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Quality objectives
5.4.1
Quality management system planning Responsibility, authority, and communication (title only) Responsibility and authority Management representative Internal communication Management review (title only) General Review input
5.4.2
ISO-4.2 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.3 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1 5.5.2 5.5.3 5.6
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
5.6.1 5.6.2
ISO-4.1 ISO-4.1
New New
mm/dd/yy mm/dd/yy
Quality manual Control of documents Control of quality records Management responsibility (title only) Management commitment Customer focus Quality policy Planning (title only)
4.2.1 4.2.2 4.2.3 4.2.4 5.0 5.1 5.2 5.3 5.4
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APPENDIX I: Reference SOPs (Continued) Subject
Clauses
Ref. SOP No.
Revision No.
Issued On
Review output Resource management (title only) Provision of resources Human resources (title only)
5.6.3 6.0
ISO-4.1 ISO-4.1
New New
mm/dd/yy mm/dd/yy
6.1 6.2
General
6.2.1
Competence, awareness, and training Infrastructure Work environment Product realization (title only)
6.2.2
ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.16 ISO-4.1 ISO-4.2 ISO-4.16
New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
7.2.1
ISO-4.9 ISO-4.9 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.3 ISO-4.4 ISO-4.3
New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3 7.3
ISO-4.3 ISO-4.4
New New
mm/dd/yy mm/dd/yy
7.3.1
ISO-4.4
New
mm/dd/yy
7.3.2
ISO-4.4
New
mm/dd/yy
7.3.3
ISO-4.4
New
mm/dd/yy
7.3.4
ISO-4.4
New
mm/dd/yy
7.3.5
ISO-4.4
New
mm/dd/yy
6.3 6.4 7.0
Planning of product realization
7.1
Customer-related processes (title only) Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development (title only) Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification
7.2
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APPENDIX I: Reference SOPs (Continued) Clauses
Ref. SOP No.
Revision No.
Issued On
Design and development validation Control of design and development changes Purchasing (title only) Purchasing process Purchasing information Verification of purchased product Production and service provision (title only)
7.3.6
ISO-4.4
New
mm/dd/yy
7.3.7
ISO-4.4
New
mm/dd/yy
7.4 7.4.1 7.4.2 7.4.3
Control of production and service provision
7.5.1
Validation of processes of production and service provision Preservation of product Control of monitoring and measuring devices Identification and traceability
7.5.2
ISO-4.6 ISO-4.6 ISO-4.6 ISO-4.6 ISO-4.10 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9
New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
7.5.5 7.6
ISO-4.15 ISO-4.11
New New
mm/dd/yy mm/dd/yy
7.5.3
Customer property Measurement, analysis, and improvement (title only)
7.5.4 8.0
ISO-4.8 ISO-4.10 ISO-4.12 ISO-4.7 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10
New New New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Subject
7.5
General
8.1
Monitoring and measurement (title only)
8.2
Customer satisfaction
8.2.1
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APPENDIX I: Reference SOPs (Continued) Subject
Clauses
Internal audit Monitoring and measurement of processes
8.2.2 8.2.3
Monitoring and measurement of products
8.2.4
Control of nonconforming product Analysis of data
8.3
Improvement (title only) Continual improvement Corrective action Preventive action
8.4 8.5 8.5.1 8.5.2 8.5.3
Ref. SOP No.
Revision No.
Issued On
ISO-4.17 ISO-4.9 ISO-4.17 ISO-4.20 ISO-4.1 ISO-4.2 ISO-4.10 ISO-4.13
New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
ISO-4.14 ISO-4.20 ISO-4.1 ISO-4.1 ISO-4.14 ISO-4.14
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
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YOUR COMPANY NAME HERE QUALITY ASSURANCE DEPARTMENT QUALITY SYSTEMS MANUAL MODEL - 2 ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9001 MANUAL Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-2
DISTRIBUTED TO 1) Managing Director 2) Quality Assurance 3) Marketing 4) ISO Management Representative 5) 6)
Revision No: 0 CONTROLLED COPY NO. Copy-1 Copy-2 Copy-3 Master
Reasons for Revision: mm/dd/yy 1) First time issued for (your company name)
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TABLE OF CONTENTS QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9001 QUALITY MANUAL Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . Scope and Field of Application . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . Quality Management System . . . . . . . . . . . Quality Policy . . . . . . . . . . . . . . . . . . . . . . Organization . . . . . . . . . . . . . . . . . . . . . . . Responsibility and Authority. . . . . . . . . . . . Resources . . . . . . . . . . . . . . . . . . . . . . . . . Management Representative . . . . . . . . . . . . Management Review . . . . . . . . . . . . . . . . . Quality System. . . . . . . . . . . . . . . . . . . . . . Contract Review. . . . . . . . . . . . . . . . . . . . . Design Control. . . . . . . . . . . . . . . . . . . . . . Document and Data Control . . . . . . . . . . . Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . Customer-Supplied Product . . . . . . . . . . . . Product Identification and Traceability . . . . Process Control . . . . . . . . . . . . . . . . . . . . . Inspection and Testing . . . . . . . . . . . . . . . . Inspection, Measuring, and Test Equipment Inspection and Test Status . . . . . . . . . . . . . Control of Nonconforming Product . . . . . . Corrective Action . . . . . . . . . . . . . . . . . . . . Handling, Storage, Packing, and Delivery . . Quality Records . . . . . . . . . . . . . . . . . . . . . Internal Quality Audits . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing . . . . . . . . . . . . . . . . . . . . . . . . . Statistical Techniques . . . . . . . . . . . . . . . . . Appendix II (Reference SOPs)
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. . .0.0 . . .1.1 . . .2.0 . . .3.0 . . .4.0 . 4.1.1 . 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 . 4.1.3 . . .4.2 . . .4.3 . . .4.4 . . .4.5 . . .4.6 . . .4.7 . . .4.8 . . .4.9 . . 4.10 . . 4.11 . . 4.12 . . 4.13 . . 4.14 . . 4.15 . . 4.16 . . 4.17 . . 4.18 . . 4.19 . . 4.20
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTRODUCTION Correspondence clause of ISO 9001:2000 Written by:
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INTRODUCTION It is in the interest of (company name) to ensure that a management system describing its total operations is carefully thought out and implemented so that the likelihood of error is reduced. This can only be achieved by implementing a quality system specific to the company’s requirements or the standard, which has global recognition in general. This manual provides references to the organizational structure, responsibilities, procedures, work instructions, and resources that have been established to affect to the company policy and documented quality objectives. The requirements of this manual are aimed at the prevention of quality failures and the maintenance of a system that provides the most effective and efficient means of achieving the documented objectives. The company has revised the existing ISO 9001 quality manual, and the contents of this manual refer to international standard ISO 9001:2000. No exclusions of the quality system requirements are permitted.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SCOPE AND FIELD OF APPLICATION Correspondence clause of ISO 9001:2000 Written by:
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SCOPE AND FIELD OF APPLICATION Worldwide, there are a number of quality systems standards in operation. Their division into categories is based on the scope of their subject matter. ISO (International Standardization Organization) is a Geneva-based, worldwide federation of national bodies that normally work together to prepare international standards through technical committees (TC). Each member body interested in a subject for which a TC has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with the ISO, also participate in the work. The U.S. representative to the ISO is the American National Standards Institute (ANSI) The international standard ISO 9001:1994 was established by Technical Committee ISO/TC 178, and is based on the British standard 5750:1987 series, European standard EN 29000:1987 series, and international standard ISO 9000:1987 series. This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. The quality manual QM2 is revised in accordance with the corresponding changes specified in the third edition of ISO 9001:2000. The international standard ISO 9001:2000 specifies quality system requirements for use where a contract between the company and customers requires demonstration of the capability to design and supply the product in compliance with the applicable regulatory requirements and customer satisfaction. The contents of the adopted standard refer to design, manufacture, and final product inspection and testing. No exclusions permitted.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REFERENCES Correspondence clause of ISO 9001:2000 Written by:
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REFERENCES ANSI/ASQCA3, Quality Systems Terminology ISO 8402-1986, Quality Vocabulary ANSI/ASQCQ 90-1987, Quality Management and Quality Assurance Standards Guidelines for Selection and Use ISO 9000-1987, Quality Management and Quality Assurance Standard - Guides for Selection and Use ISO 9001:1994, Quality System — Model for Quality Assurance in Design, Development, Production, Installation, and Servicing ISO 9001:2000, Quality Management System Requirements. Design, Manufacture, and Final Product Inspection and Testing.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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DEFINITIONS For the purpose of standard ISO/FDIS 9001:2000E, the terms and definitions given in ISO 9000 apply.
Analysis Certificate The analysis certificate is a document that gives the results of the inspection made on a representative sample taken from a product before its delivery. It must contain the results of all checks in a list approved jointly by the client and the supplier.
Auditor A person who is qualified and authorized to perform all or any portion of a quality system audit is called an auditor.
Audit An audit is a systematic and independent examination to deter mine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives.
Audit Organization An organization that regularly conducts quality assurance management system audits to a required standard is known as an audit organization.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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Batch A batch refers to assignments of a batch of finished products to a client as a function of that client’s requirements.
Conformity Conformity refers to the state of a product satisfying specified requirements.
Documentation Documentation means any recorded or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Documentation Level The position of a quality document in the quality assurance documentation system is its documentation level.
First Party Audits Audits carried out internally by an organization are known as first party audits.
Inspection Inspection refers to examination or measurement to verify whether an item or activity conforms to a specified requirement.
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Inspectors Inspectors are appointed by the purchaser to provide advice on matters relating to product and inspection and to verify the achievement of the quality specified.
Lead Auditor An auditor who is qualified and authorized to manage a quality system audit is known as a lead auditor.
Management Review The management review is a compulsory evaluation carried out by general management on the state and suitability of the quality system with respect to quality policy and new objectives resulting from the changed situation.
Nonconformity Nonconformity refers to the state of a product not satisfying specified requirements.
Organization An organization is a unit to which this international standard applies.
Provisional Auditor A person who meets all requirements for registration except for audit experience is known as a provisional auditor.
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Quality Quality refers to all properties and characteristics of a service that make it capable of satisfying a client’s expressed or specified needs.
Quality Audit A quality audit is a methodical and independent examination in order to determine if quality-related activities and results satisfy predetermined requirements, and if these requirements are implemented efficiently and are capable of achieving the objectives.
Quality Assurance Quality assurance refers to all predetermined and systematic actions necessary to give appropriate confidence that a product or a service satisfies given quality requirements.
Quality Control Quality control is that part of good manufacturing practice which is concerned with sampling, specifications, and testing. Organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out, and that materials are not released for use, and that products are not released for sale or supply, until their quality has been judged to be satisfactory.
Quality Manual The quality manual is a document describing general measures taken by the company to ensure that quality of its products or services.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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Quality Planning A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be referred to as quality plan.
Quality Policy The overall quality intentions and direction of an organization formally expressed by top management is called the quality policy.
Quality (or Quality-Related) Record The quality record refers to the filled-in record documents proving that the quality assurance and quality control actions have been done.
Quality System The quality system consists of the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
Quality Surveillance Quality surveillance refers to the continued monitoring and verification of the status of procedures, methods, conditions, processes, products and services, and analysis of records in relation to stated references to ensure that specified requirements for quality are being met.
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Representative Sample The representative sample is a sample taken using a clearly defi ned procedure in order to obtain information about a batch.
Second Party Audits Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of products by one company from another within the same group.
Specification Specification refers to a document that specifies the requirements with which the product and/or material must comply.
Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are known as third party audits.
Traceability Traceability is the capability of finding the history, use, or location of an article by means of a recorded identification.
Validation The act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produced a valid result is known as validation.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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Verification Verification refers to the act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.0, ISO 9001:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
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The contents of the ISO 9001:1994 international standards are described below in correspondence with ISO 9001:2001 to define quality system requirements and management responsibilities. Correspondence between ISO 9001:1994 and ISO 9001:2000 Clause
1.0 2.0 3.0 4.0 4.1 4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.3 4.2 4.2.1 4.2.2 4.2.3 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.4 4.4.1
ISO 9001:1994
Scope Normative reference Definitions Quality system requirements (title only) Management responsibility (title only) Quality policy Organization (title only) Responsibility and authority Resources Management representative Management review Quality system (title) General Quality system procedures Quality planning Contract review (title only) General Review Amendment to a contract Records Design control (title only) General
ISO 9001:2000
1.0 2.0 3.0
5.1 + 5.3 + 5.4.1 5.5.1 5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 4.2.1 5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.2.2 7.2.2
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.0, ISO 9001:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
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Correspondence between ISO 9001:1994 and ISO 9001:2000 (Continued) Clause
4.4.2 4.4.3
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4.9
Design and development planning Organizational and technical interfaces Design input Design output Design review Design verification Design validation Design changes Document and data control (title only) General Document and data approval and issue Document and data changes Purchasing (title only) General Evaluation of subcontractors Purchasing data Verification of purchased product Control of customer-supplied product Product identification and traceability Process control
4.10
Inspection and testing (title only)
4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.7 4.8
ISO 9001:2000
7.3.1 7.3.1 7.2.1 7.3.3 7.3.1 7.3.1 7.3.1 7.3.7
+ 7.3.2 + 7.3.4 + 7.3.5 + 7.3.6
4.2.1 + 4.2.3 4.2.3 4.2.3
7.4.1 7.4.2 7.4.3 7.5.4 7.5.3 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.0, ISO 9001:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
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Correspondence between ISO 9001:1994 and ISO 9001:2000 (Continued) Clause
ISO 9001:1994
4.10.1 4.10.2 4.10.3 4.10.4 4.10.5 4.11
General Receiving inspection and testing In-process inspection and testing Final inspection and testing Inspection and test records Control of inspection, measuring, and test equipment (title only) General Control procedure Inspection and test status Control of nonconforming product (title only) General Review and dispositioning of nonconforming product Corrective and preventive action (title only) General Corrective action Preventive action Handling, storage, packaging, preservation, and delivery (title only) General Handling Storage Packaging
4.11.1 4.11.2 4.12 4.13 4.13.1 4.13.2 4.14 4.14.1 4.14.2 4.14.3 4.15
4.15.1 4.15.2 4.15.3 4.15.4
ISO 9001:2000
7.1 + 8.1 7.4.3 + 8.2.4 7.4.3 + 7.5.1 + 8.2.4 7.4.3 + 8.2.4 7.5.3 + 8.2.4
7.6 7.6 7.5.3
8.3 8.3
8.5.2 + 8.5.3 8.4 + 8.5.2 8.4 + 8.5.3
7.5.5 7.5.5 7.5.5
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.0, ISO 9001:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
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Correspondence between ISO 9001:1994 and ISO 9001:2000 (Continued) Clause
4.15.5 4.15.6 4.16 4.17 4.18 4.19 4.20 4.20.1 4.20.2
ISO 9001:1994
Preservation Delivery Control of quality records Internal quality audits Training Servicing Statistical techniques (title only) Identification of need Procedures
ISO 9001:2000
7.5.5 7.5.1 + 7.5.5 4.2.4 8.2.2 + 8.2.3 6.2.1 + 6.2.2 7.1 + 7.5.1 8.1 + 8.2.3 + 8.2.4 + 8.4
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY POLICY Correspondence clause of ISO 9001:2000 Written by:
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QUALITY POLICY [Quality policy statement here] [Should be by top management] Top management has provided evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by 1. Ensuring the availability of resources 2. Conducting management reviews and ensuring that quality objectives are established 3. Establishing the quality policy 4. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
Quality Policy Our immediate and long-term success is dependent on the following elements: Compling with customer’s provided specifications Following standard operating procedures Meeting the registration requirements of the regulatory bodies
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The “quality” path, to which we have all been firmly committed for many years, will lead us to maintain the ISO 9001: 2000 certification. Our quality objective is ambitious but realistic. It involves teamwork and is a challenge that we accept together. Our future depends on it. It is ensured that the quality policy is appropriate to the purpose of the organization and includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system. The policy provides a framework for establishing and reviewing quality objectives, communicated and understood within the organization, and is reviewed for continuing suitability.
Quality Objectives It is ensured that quality objectives, including those needed to meet requirements for product compliance, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy.
Signature Designation of the Head of the Company
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL ORGANIZATION Correspondence clause of ISO 9001:2000 Written by:
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ORGANIZATION CHART HERE Describe the site organization chart of your company and the number of employees. Describe departments involved, field of activity, interrelationships, definitions, and terminologies used within the company. The (company name) head office is located at (address), and is currently involved in the manufacturing of the following products/services. Provide list of products. Provide list of services. The company specializes in the production of (provide details). The plant organization is shown in the chart on the following page. The key functions of the departments are as follows. The common quality associated terms used in the company are described below.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESPONSIBILITY AND AUTHORITY Correspondence clause of ISO 9001:2000 Written by:
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ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY Every employee whose work may ultimately affect product quality and service has the responsibility, authority, and organizational freedom to: 1. Identify and record product- or service-related problems 2. Recommend, initiate, or provide solutions through systemic review and approvals 3. Initiate corrective action to prevent the occurrence of product nonconformity 4. Verify the implementation of solutions 5. Monitor and control further processing, delivery, or installation of a nonconforming product or service until the deficiency or unsatisfactory condition has been corrected The management has ensured that the responsibilities, authorities, and their interrelation are defined and communicated within the organization.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESOURCES Correspondence clause of ISO 9001:2000 Written by:
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RESOURCES Personnel performing work affecting product quality are competent and are selected on the basis of appropriate education, training, skills, and experience.
INFRASTRUCTURE The organiztion has determined, provided, and maintained the infrastructure needed to achieve conformity to product requirements. The basic infrastructure includes buildings, workspace and associated utilities, process equipment, both hardware and software, and supporting services such as transport or communication.
MANAGEMENT COMMITMENT The top management of (company name) is committed to the development and implementation of the quality management system and continually improving its effectiveness by: 1. 2. 3. 4. 5.
Ensuring the availability of resources Conducting management reviews Ensuring that quality objectives are established Establishing the quality policy Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESOURCES Correspondence clause of ISO 9001:2000 Written by:
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PROVISION OF RESOURCES The management has determined and provided the resources needed to implement and maintain the quality management system, continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REPRESENTATIVE Clause — 4.1.2.3, ISO 9001:1994 Correspondence clause of 5.5.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
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MANAGEMENT REPRESENTATIVE The [quality assurance manager] is appointed as the management representative and has the defined authority and responsibility, irrespective of other responsibilities, to ensure that the requirements of all pertinent standards are implemented and maintained. The management representative has the full responsibility for: 1. Ensuring that processes needed for the quality management system are established, implemented, and maintained 2. Reporting to top management on the performance of the quality management system and any need for improvement 3. Ensuring the promotion of awareness of customer requirements throughout the organization 4. Forming a liaison with external parties on matters relating to the quality management system
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Clause — 4.1.3, Revision 0 ISO 9001:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
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MANAGEMENT REVIEW The quality system is reviewed on a quarterly basis through management reviews to ensure continuing suitability and effectiveness. The data and results of the input and output reviews are recorded and maintained. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
REVIEW INPUT The input to the management review includes information on: 1. 2. 3. 4. 5. 6. 7.
Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective action Follow-up actions from previous management reviews Planned changes that could affect the quality management system Recommendations for improvement
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3, Revision 0 ISO 9001:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT The output from the management review includes decisions and actions related to: 1. Improvement of the effectiveness of the quality management system and its processes 2. Improvement of the product related to customer requirements 3. Resource needs
CONTINUAL IMPROVEMENT The organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management reviews.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
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GENERAL A quality management system is established, maintained, and documented as a means to ensure that products and services conform to specified requirements. This quality system is designed to comply with the ISO 9001:2000 standard. The quality systems responsibilities are tabulated in Table 1 (amend the table as relevant to your company). The quality planning matrix is described in Table 1. Table 1 Correspondence Clause ISO 9001:2000
ISO-9001 CLAUSE
4.1
Management responsibilities
4.2
Quality system
4.3
Contract review
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
5.1 + 5.3 + 5.4.1 + 5.5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 5.4.2 + 6.2.1 + 7.1 5.2 + 7.2.1 + 7.2.2 + 7.2.3
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * – – – – * X *
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Correspondence clause of ISO 9001:2000 Written by: Date Supersedes
Date Issue
Page 2 of 6
mm/dd/yyyy
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Table 1 (Continued) Correspondence Clause ISO 9001:2000
ISO-9001 CLAUSE
4.4
Design control
4.5
Document and data control Purchasing
4.6
4.7
4.8
4.9
Control of customersupplied product Product identification and traceability Process control
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.3.1 7.2.1 + 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 4.2.1 + 4.2.3
* * – * – – – X * – * –
* * * * * * * X * * * *
7.4.1 7.4.2 7.4.3 7.5.4
* * – * * – – * X – – *
7.5.3
* * X * * – – * * * * *
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
– * X * – – – * – * – –
– X – * – – – – – – – –
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Correspondence clause of ISO 9001:2000 Written by: Date Supersedes
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Table 1 (Continued) Correspondence Clause ISO 9001:2000
ISO-9001 CLAUSE
4.10
Inspection and testing
4.11
Inspection, measurement, and test equipment Inspection and test status Control of nonconforming product Corrective actions Handling, storage, packaging, preservation, and delivery Quality records Internal quality audits Training
4.12 4.13
4.14 4.15
4.16 4.17 4.18
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.1 + 8.1 7.4.3 + 8.2.4 7.5.1 7.5.3 7.6
– X * * – – – – – * – –
7.5.3
– X * * – – – * – * – –
8.3
* * * X * * – * * * * *
8.5.2 + 8.5.3 8.4 7.5.5 + 7.5.1
* X * * * * * * * * * *
– * * * – X – * – * – –
– * * * * – – – – * – X 4.2.4 8.2.2 + 8.2.3
* * * X * * * * * * * * * X * * * * – * * * * *
6.2.1 + 6.2.2
* X * * * * X * * * * *
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
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Table 1 (Continued) Correspondence Clause ISO 9001:2000
ISO-9001 CLAUSE
4.19 4.20
Servicing Statistical techniques
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.1 + 7.5.1 8.1 + 8.2.3 + 8.2.4 + 8.4
* * * * * – – * * * X * * X * * – – – – – * – –
X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, – NOT APPLICABLE Key: ADM PRD SHP PDL PAC MPM
= = = = = =
Administration (Management) Production Shipping Product Development Lab Packaging Materials Planning Manager
QUA QCD PER PUR MKT MAI
= = = = = =
Quality Assurance Quality Control Department Personnel Purchase Marketing Maintenance
QUALITY SYSTEM PROCEDURES The organization has identified the processes needed for the quality management system and their application throughout the organization. These processes are managed by the organization in accordance with the requirements of these international standards. The quality management system documentation is reviewed, updated, and maintained both in hardware and software form.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
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CONTROL MANUAL The scope of the quality management system includes details of and justification for any exclusions, the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management system.
MANAGEMENT COMMITMENT The organization has committed to the development and implementation of the quality management system and continually improving its effectiveness.
QUALITY OBJECTIVES (Company name) has ensured that quality objectives, including those needed to meet requirements for products, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy.
DOCUMENTATION Documented quality system procedures and instructions are prepared to meet the requirements of all pertinent standards. This manual is reviewed, revised (as required), and reapproved annually. Quality planning is performed by the quality assurance department to fully meet specified requirements. Procedures and instructions for quality are kept current to conform to specified requirements. Quality records are properly prepared and identified and can be in any form or medium.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9001:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
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IMPLEMENTATION [Quality assurance system] procedures and instructions are updated as needed. When needed to achieve the required standard of quality, quality control, inspection techniques, and instrumentation are updated. As needed to achieve the required quality, any controls, processes, inspection equipment, fixtures, total production resources, and skills are identified and acquired. Standards of acceptability for all features and requirements are clear, complete, and understood (including those that contain a subjective element). The production process, product installation, inspection, and test procedures are compatible with the design and requirements. All quality system procedures and instruction changes are properly documented.
QUALITY PLANNING The planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. It is ensured that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience.
PLANNING OF PRODUCTION REALIZATION The organization has planned and developed the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTRACT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3, Revision 0 ISO 9001:1994 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
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CONTRACT REVIEW Procedures for contract review are established and maintained. The [order entry department] ensures that our customers’ requirements are adequately defined and documented. [Production control planners] ensure that the plant has the capability to meet contractual requirements. [Customer service] ensures that a method for solving contractual differences has been developed and is in use.
CUSTOMER FOCUS It is ensured that the product shall meet the customer requirements.
DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT The organization determines requirements specified by the customer, requirements not stated by the customer but necessary for specifi ed use or known and intended use, r egulatory requirements, and any additional requirements.
CUSTOMER COMMUNICATION The organization determines and implements effective arrangements for communicating with customers.
Reference Procedure — [Number- ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9001:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
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Page 1 of 4
GENERAL Procedures are established and maintained to control and verify the design of the product and service in order to ensure the specified requirements are met.
DESIGN AND DEVELOPMENT PLANNING The [design department] identifies the responsibility for each design and development activity. Design and verification activities are planned and assigned to qualified staff equipped with adequate resources. Organizational and technical interfaces between different groups are identified, and the necessary information is documented, transmitted, and regularly reviewed. The organization plans and controls the design and development of the product.
DESIGN INPUT The [design department] and [plant product engineering] ensure that the design input requirements relating to the product are identified, documented, and their selection is reviewed to ensure adequacy. Incomplete, ambiguous, or conflicting requirements are resolved when defining these requirements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9001:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
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Page 2 of 4
DESIGN OUTPUT The [design department] and [plant product engineering] ensure that the design output meets the design input requirements. Design output is documented and expressed in terms of requirements, calculations, and analysis. Engineering drawings and/or specifications contain or refer to acceptance criteria. Design output conforms to appropriate regulatory requirements [e.g., put names of agencies here], whether or not these have been stated in the input information. Engineering drawings and/or specifications identify those characteristics of the design that are crucial to the safe and proper functioning of the product.
DESIGN REVIEW The organization plans and controls the design and development of the product. During the design and development planning, the organization determines the design and development stages, the review, verification, and validation that are appropriate to each design and development stage, and the responsibilities and authorities for design and development.
DESIGN AND DEVELOPMENT REVIEW At suitable stages, systematic reviews of design and development are conducted.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9001:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
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Page 3 of 4
DESIGN VERIFICATION Design verification is assigned to the [research and development department] and is planned, established, and documented. [Engineering standard practice instructions] ensure that design output meets the design input requirements by means of designing control measures such as: 1. 2. 3. 4.
Holding and recording design reviews Undertaking qualification tests and demonstrations Carrying out alternative calculations Comparing the new design with a similar proven design, if available
Design verification is performed to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions are maintained.
DESIGN VALIDATION Design and development validation is performed in accordance with planned arrangement to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Wherever practicable, validation is completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions are maintained.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9001:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
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Page 4 of 4
DESIGN CHANGES [Engineering standard practice instructions] are established and maintained for the identification, documentation, and appropriate review and approval of all changes and modifications.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENT AND DATA CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5, ISO 9001:1994 4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
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GENERAL The quality management system documentation includes quality policy, a quality manual, and documented procedures required by this international standard and quality standards.
DOCUMENT, DATA APPROVAL, AND ISSUES [Engineering standard practice instructions] are established and maintained to control all documents and data that relate to the standard’s requirements. These documents are reviewed and approved for adequacy by authorized personnel prior to being issued. Current revisions of documents are identified by the [master list] on the computer system. The [master list] and the [manufacturing plant procedures] ensure that the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed. The [manufacturing plant procedures] ensure that obsolete documents are promptly removed from all points of issue or use.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENT AND DATA CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5, ISO 9001:1994 4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
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DOCUMENT AND DATA CHANGES Document changes/modifications are reviewed and approved by the [design department], which has access to all pertinent background information upon which to base its review and approval. The change and the nature of the change are identified on the document or on an appropriate attachment, unless it is not practicable. Documents are reissued promptly after changes are made. Documents required by the quality management system are controlled. A documented procedure is established to define the controls needed.
Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6, ISO 9001:1994 7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
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GENERAL The [purchasing] and [quality assurance departments] ensure that purchased products conform to specified requirements.
VENDOR ASSESSMENT Vendors are selected on the basis of their ability to meet quality requirements. An approved vendor list is established and maintained. Only approved vendors are used. Vendors are approved based on [parts qualification report] and performance as to the type of product and service being purchased. Vendor evaluation ensures that the vendor has effective quality system controls.
PURCHASING DATA The [buyers] review and approve purchase orders for adequacy of specified requirements prior to release. Purchasing documents contain data clearly describing the product ordered, including, where applicable: 1. The type, class, style, grade, or other precise identification 2. The title or other positive identification, applicable issue of specifications, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel 3. The title, number, and issue date of the specification to be applied to the product
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6, ISO 9001:1994 7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
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VERIFICATION OF PURCHASED PRODUCT Our customer or our customer’s representatives are afforded the right to verify at the source or upon receipt that the purchased product conforms to the specified requirements. Product verification by the customer does not absolve our operation of the responsibility to provide a fully acceptable product, nor does it preclude subsequent rejection. When our customer carries out product verification at a vendor’s plant, such verification is used as evidence of effective quality control of the vendor.
Reference Procedure — [Number ISO-4.6 dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER-SUPPLIED PRODUCT Clause — 4.7, ISO 9001:1994 Correspondence clause of 7.5.4 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
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Revision 0
Approved by: Page 1 of 1
CUSTOMER-SUPPLIED PRODUCT Customer-supplied products are verified, stored, and maintained to prevent deterioration or loss. It is ensured that: A customer-supplied product is prevented from deterioration or loss. The nonconforming customer-supplied product is segregated from the production streams recorded and reported to the customer. The contract describes the conditions of handling the customersupplied product (or by other documented specification). Customer property includes intellectual property rights.
Reference Procedure — [Number ISO-4.7, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRODUCT IDENTIFICATION AND TRACEABILITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.8, ISO 9001:1994 7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
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PRODUCT IDENTIFICATION The identification of the product is established and maintained for all products to all applicable drawings, specifications, or other documents during all stages of production, delivery, and installation.
PRODUCT TRACEABILITY Where traceability is specified, the product and subassemblies of the product have unique recorded identification.
Reference Procedure — [Number ISO-4.8, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROCESS CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9, Revision 0 ISO 9001:1994 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Checked by:
Approved by:
Date Supersedes
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PROCESS CONTROL Production operations, which directly affect quality, are identified and planned to ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following: 1. Documented work instructions defining the manner of production and installation, where the absence of instructions would adversely affect quality 2. Use of suitable production and installation equipment, a suitable working environment, compliance with reference standards, codes, and quality plans 3. Monitoring and control of suitable process and product characteristics during production and installation 4. The approval of processes and equipment, as appropriate 5. Engineering drawings and inspection plans stipulating the acceptance and rejection criteria 6. Availability of suitable buildings and workplaces
SPECIAL PROCESSES These are processes, the results of which cannot be fully verified by subsequent inspection and testing of the product and where, for example, process deficiencies may become apparent only after the product is in use. Accordingly, continuous monitoring and/or compliance with documented procedures are required to ensure that the specified requirements are met. Records are maintained for all qualified process equipment and personnel.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROCESS CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9, Revision 0 ISO 9001:1994 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
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PLANNING OF PRODUCTION REALIZATION Planning of product realization is consistent with the requirements of the other processes of the quality management system, and the organization determines the elements as appropriate.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9001:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 3
mm/dd/yyyy
mm/dd/yyyy
GENERAL The organization has planned and developed the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system and considers monitoring, measurement, analysis, and improvement processes needed.
RECEIVING INSPECTION AND TEST Consideration is given to the control exercised at the source and documented evidence of quality conformance provided. All incoming materials are inspected or otherwise verified as to conforming to specified requirements before being released for use to production. This verification is in accordance with the quality plan or documented procedures. All incoming materials released for urgent production purposes are positively identified and recorded in order to permit immediate recall in the event of nonconformance. The organization monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9001:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 3
mm/dd/yyyy
mm/dd/yyyy
IN-PROCESS INSPECTION AND TESTING All in-process inspection and test requirements, as specified by contract, are controlled by these means: 1. Inspecting, testing, and identifying the product as required by the quality plan or documented procedures 2. Establishing product conformance to specified requirements by use of process monitoring and control methods 3. Holding the product until the required inspection and tests have been completed or necessary reports have been received and verified (except when the product is released under positive recall procedures); release under positive recall procedures does not preclude the activities of (1) above. 4. Identifying a nonconforming product 5. Considering controlled conditions, as applicable
FINAL INSPECTION AND TESTING The [quality plan] ensures that all specified inspections and tests, including those specified either upon receipt of the product or in process, have been carried out and that all data meet the specified requirements. All final inspections and testing are performed in accordance with the [quality plan and specifications] to complete the evidence of product conformance to the specified requirements. No product is shipped until all specified requirements have been satisfactorily completed and the associated data and documentation are complete and authorized.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9001:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 3 of 3
mm/dd/yyyy
mm/dd/yyyy
INSPECTION AND TEST RECORDS [Inspection records] are maintained in order to provide evidence that the product has passed an inspection and/or test with defined acceptance criteria.
IDENTIFICATION AND TRACEABILITY Where appropriate, the organization identifies the product by suitable means throughout product realization.
Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION, MEASURING, AND Clause — 4.11, TEST EQUIPMENT ISO 9001:1994 Correspondence clause of 7.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 2
INSPECTION, MEASURING, AND TEST EQUIPMENT The [calibration system] controls, calibrates, and maintains inspection, measuring, and test equipment to demonstrate the conformance of the product to the specified requirements. Equipment is used in such a manner so as to ensure that measurement uncertainty is known and is consistent with the required measurement capability. The measurements made are identified, the accuracy is stated, and the appropriate inspection, measuring, and test equipment is used. [Calibration procedures] are established and maintained to include details of equipment type, identification number, location, frequency of checks, check method, acceptance criteria, and the action to be taken when check results are unsatisfactory. Calibration records are maintained, and calibration environmental conditions are controlled. All inspection, measuring, and test equipment is capable of the accuracy and precision necessary. Prior to use, all inspection, measuring, and test equipment is identified, calibrated, and adjusted as required. Calibration and adjustments are made are against standards of certified equipment, traceable to the National Institute of Standards and Technology (NIST, where no such standard exists, the basis used for calibration is documented). Inspection, measuring, and test equipment is identified with a suitable indicator or approved identification record to show the calibration status. When inspection, measuring, and test equipment is found to be out of calibration, an assessment of the validity of previous inspections and tests are made and documented. The accuracy and fitness for use of inspection, measuring, and test equipment are maintained by controlling the handling, preservation, and storage of the equipment. Inspection, measuring, and test equipment and test facilities, including both test hardware and test software, are safeguarded from adjustments that would invalidate the calibration setting.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION, MEASURING, AND Clause — 4.11, TEST EQUIPMENT ISO 9001:1994 Correspondence clause of 7.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 2 of 2
Test hardware (e.g., jigs, fixtures, templates, and patterns) or test software is checked to ensure capability of verifying the acceptability of the product, prior to release, for use during production or installation. Such hardware and software is controlled by periodic checks. Records are maintained. In addition, the organization assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization takes appropriate action on the equipment and any product affected. Records of the results of calibration and verification are maintained. Note: See ISO 10012-1 and ISO 10012-2 for guidance.
Reference Procedure — [Number ISO-4.11, dated mm-dd-yyyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TEST STATUS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.12, ISO 9001:1994 7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INSPECTION AND TEST STATUS The inspection and test status of the product is identified by markings, authorized tags, labels, routing cards, inspection records, test software, and physical location, which indicate the conformance or nonconformance of the product with regard to inspection and tests performed. The identification of inspection and test status is maintained, as necessary, throughout production and installation of the product to ensure that only product that has passed the required inspection and test is shipped, used, or installed. Records identify the inspection authority responsible for the release of conforming product.
Reference Procedure — [Number ISO-4.12, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF Clause — 4.13, NONCONFORMING PRODUCT ISO 9001:1994 Correspondence clause of 8.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 2
CONTROL OF NONCONFORMING PRODUCT Nonconforming product is controlled to ensure that any product that does not conform to specified requirements is prevented from inadvertent use or installation. The [procedures] provide for identification, documentation, evaluation, and segregation when practical, as well as disposition of nonconforming product and notification to the functions concerned.
NONCONFORMITY REVIEW AND DISPOSITION The responsibility for review and authority for the disposition of nonconforming product is assigned to a [material review board]. Nonconforming product is reviewed in accordance with [material review board procedures]. Disposition of nonconforming product may be: 1. 2. 3. 4. 5.
Rework to meet the specified requirements Accept with repair by concession Accept without repair by concession Regrade for alternative applications Scrap
Where required by contract, the proposed use or repair of any product that does not conform to specified requirements is reported for concession to the customer or the customer’s representative. The description of nonconformity that has been accepted, as well as repairs, is recorded to denote the actual condition. Repaired and reworked products are reinspected in accordance with the [quality plan].
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF Clause — 4.13, NONCONFORMING PRODUCT ISO 9001:1994 Correspondence clause of 8.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 2 of 2
When nonconforming product is detected after delivery or use has begun, the organization takes action appropriate to the effects of the nonconformity.
Reference Procedure — [Number ISO-4.13, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CORRECTIVE ACTION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14, ISO 9001:1994 8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION [Corrective action procedures] are established, documented, and maintained. They include: 1. Investigating the cause of nonconforming product and the corrective action needed to prevent recurrence 2. Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect and eliminate potential causes of nonconforming product 3. Initiating preventive actions to deal with problems to a level corresponding to the risk encountered 4. Applying controls to ensure corrective actions are taken and that they are effective 5. Implementing and recording changes in procedures resulting from corrective action The organization initiates actions to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions appropriate to the effects of the potential problem are initiated as appropriate.
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL HANDLING, STORAGE, PACKING, AND DELIVERY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.15, ISO 9001:1994 7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKING, AND DELIVERY [Warehouse procedures] are established, documented, and maintained for the handling, storage, packaging, and delivery of the product. [Warehouse procedures] establish the methods and means of handling to prevent damage or deterioration. [Storage areas] or stock rooms are provided to prevent damage or deterioration of the product, pending use or delivery. Appropriate methods for authorizing receipt and dispatch to and from such areas are stipulated. The condition of any product in stock is assessed at appropriate intervals. [Packing system] establishes the processes of packing, preserving, and marking, to the extent necessary, to ensure conformance to specified requirements and identifies, preserves, and segregates all product from the time of receipt until the plant’s responsibility ceases. [Shipping system] provides for the protection of the product through the delivery of the product to its final destination.
Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY RECORDS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.16, ISO 9001:1994 4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS Quality records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Quality records are made available for evaluation by the customer or the customer’s representative for an agreed period. All quality records are legible and identifiable to the product involved. Quality records are stored and maintained in such a way that they are readily retrievable in storage facilities, which minimizes deterioration and prevents loss. Quality records are maintained to demonstrate achievement of the required quality and the effective operation of the quality system. The retention time of quality records is according to the record retention policy. [Record procedures] are established and maintained for the identifying, collecting, indexing, filing, storing, maintaining, and disposing of quality records.
Reference Procedure — [Number ISO-4.16, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTERNAL QUALITY AUDITS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.17, ISO 9001:1994 8.2.2 + 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTERNAL QUALITY AUDITS A comprehensive system of planned and documented internal quality audits is established to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. Audits are scheduled on the basis of the status and importance of the activity. The audits and the follow-up actions are carried out in accordance with ANSI/ASQC Q1-1986 or ISO 10011-1, ISO 11-1, and ISO 10011-3. The results of the audit are documented and brought to the attention of the personnel with responsibility in the area audited. The management personnel responsible for that area take timely corrective action for the deficiencies found by the audit. The selection of auditors and conduct of audits ensure the objectivity and impartiality of the audit process.
Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TRAINING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.18, ISO 9001:1994 6.2.1 + 6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
TRAINING Procedures are established and maintained for identifying the training needs and providing for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks are qualified on the basis of appropriate education, training, and/or experience, as required. Training records are maintained.
Reference Procedure — [Number ISO-4.18, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SERVICING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.19, ISO 9001:1994 7.1 + 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SERVICING Where servicing is specified in the contract, procedures are established and maintained for performing and verifying that service meets the specified requirements. The organization plans and carries out production and service provisions under controlled conditions as applicable.
Reference Procedure — [Number ISO-4.19, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL STATISTICAL TECHNIQUES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.20, Revision 0 ISO 9001:1994 8.1 + 8.2.3 + 8.2.3 + 8.4 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
STATISTICAL TECHNIQUES Where appropriate, procedures are established for identifying adequate statistical techniques required for verifying the acceptability of process capability and product characteristics. The organization determines, collects, and analyses appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement to the quality management system can be made.
Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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Appendix II Reference SOPs
Subject
Quality management systems requirement (title only) Scope General Application Normative reference Terms and definitions Quality management system (title only) General requirements Documentation requirements (title only) General
Clauses ISO 9001 :2000
Ref. SOP No
Revision No.
Issued On
1.0 1.1 1.2 2.0 3.0 4.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
4.1 4.2
New New New New New New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Quality manual Control of documents Control of quality records Management responsibility (title only) Management commitment
4.2.2 4.2.3 4.2.4 5.0
Customer focus Quality policy Planning (title only)
5.2 5.3 5.4
Quality objectives
5.4.1
Quality management system planning Responsibility, authority, and communication (title only) Responsibility and authority Management representative Internal communication Management review (title only) General
5.4.2
ISO-4.2 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.3 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1 5.5.2 5.5.3 5.6
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
5.6.1
ISO-4.1
New
mm/dd/yy
4.2.1
5.1
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Appendix II Reference SOPs (Continued) Clauses ISO 9001 :2000
Ref. SOP No
Revision No.
Issued On
Review input Review output Resource management (title only) Provision of resources Human resources (title only)
5.6.2 5.6.3 6.0
ISO-4.1 ISO-4.1 ISO-4.1
New New New
mm/dd/yy mm/dd/yy mm/dd/yy
6.1 6.2
General
6.2.1
Competence, awareness, and training Infrastructure Work environment Product realization (title only)
6.2.2
ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.16 ISO-4.1 ISO-4.2 ISO-4.16
New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Planning of product realization
7.1
Customer-related processes (title only) Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development (title only) Design and development planning Design and development inputs Design and development outputs Design and development review
7.2 7.2.1
ISO-4.9 ISO-4.9 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.3 ISO-4.4 ISO-4.3
New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3 7.3
ISO-4.3 ISO-4.4
New New
mm/dd/yy mm/dd/yy
7.3.1
ISO-4.4
New
mm/dd/yy
7.3.2
ISO-4.4
New
mm/dd/yy
7.3.3
ISO-4.4
New
mm/dd/yy
7.3.4
ISO-4.4
New
mm/dd/yy
Subject
6.3 6.4 7.0
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Appendix II Reference SOPs (Continued) Clauses ISO 9001 :2000
Ref. SOP No
Revision No.
Issued On
Design and development verification Design and development validation Control of design and development changes Purchasing (title only) Purchasing process Purchasing information Verification of purchased product Production and service provision (title only)
7.3.5
ISO-4.4
New
mm/dd/yy
7.3.6
ISO-4.4
New
mm/dd/yy
7.3.7
ISO-4.4
New
mm/dd/yy
7.4 7.4.1 7.4.2 7.4.3
Control of production and service provision
7.5.1
Validation of processes of production and service provision Identification and traceability
7.5.2
ISO-4.6 ISO-4.6 ISO-4.6 ISO-4.6 ISO-4.10 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9
New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis, and improvement (title only)
7.5.4 7.5.5 7.6
ISO-4.8 ISO-4.10 ISO-4.12 ISO-4.7 ISO-4.15 ISO-4.11
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
General
8.1
ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.10 ISO-4.17 ISO-4.20
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Subject
7.5
7.5.3
8.0
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Appendix II Reference SOPs (Continued)
Subject
Clauses ISO 9001 :2000
Monitoring and measurement (title only)
8.2
Customer satisfaction
8.2.1
Internal audit Monitoring and measurement of processes
8.2.2 8.2.3
Monitoring and measurement of products
8.2.4
Control of nonconforming product Analysis of data
8.3
Improvement (title only) Continual improvement Corrective action Preventive action
8.5 8.5.1 8.5.2 8.5.3
8.4
Ref. SOP No
Revision No.
Issued On
ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.9 ISO-4.17 ISO-4.20 ISO-4.1 ISO-4.2 ISO-4.10 ISO-4.13
New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
ISO-4.14 ISO-4.20 ISO-4.1 ISO-4.1 ISO-4.14 ISO-4.14
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
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200.20.3
YOUR COMPANY NAME HERE QUALITY ASSURANCE DEPARTMENT QUALITY SYSTEMS MANUAL MODEL - 3 ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9002 MANUAL Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
mm/dd/yyyy
mm/dd/yyyy
QM-3
DISTRIBUTED TO 1) Managing Director 2) Quality Assurance 3) Marketing 4) ISO Management Representative 5) 6)
Revision No: 0 CONTROLLED COPY NO. Copy-1 Copy-2 Copy-3 Master
Reasons for Revision: mm/dd/yy 1) First time issued for (your company name)
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TABLE OF CONTENTS QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9002 QUALITY MANUAL Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . Scope and Field of Application . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . Quality Management System . . . . . . . . . . . Quality Policy . . . . . . . . . . . . . . . . . . . . . . Organization . . . . . . . . . . . . . . . . . . . . . . . Responsibility and Authority. . . . . . . . . . . . Resources . . . . . . . . . . . . . . . . . . . . . . . . . Management Representative . . . . . . . . . . . . Management Review . . . . . . . . . . . . . . . . . Quality System. . . . . . . . . . . . . . . . . . . . . . Contract Review. . . . . . . . . . . . . . . . . . . . . Design Control (not applicable) . . . . . . . . . Document and Data Control . . . . . . . . . . . Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . Customer-Supplied Product . . . . . . . . . . . . Product Identification and Traceability . . . . Process Control . . . . . . . . . . . . . . . . . . . . . Inspection and Testing . . . . . . . . . . . . . . . . Inspection, Measuring, and Test Equipment Inspection and Test Status . . . . . . . . . . . . . Control of Nonconforming Product . . . . . . Corrective Action . . . . . . . . . . . . . . . . . . . . Handling, Storage, Packing, and Delivery . . Quality Records . . . . . . . . . . . . . . . . . . . . . Internal Quality Audits . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . Statistical Techniques . . . . . . . . . . . . . . . . . Appendix III (Reference SOPs)
Clauses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . .0.0 . . .1.1 . . .2.0 . . .3.0 . . .4.0 . 4.1.1 . 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 . 4.1.3 . . .4.2 . . .4.3 . . .4.4 . . .4.5 . . .4.6 . . .4.7 . . .4.8 . . .4.9 . . 4.10 . . 4.11 . . 4.12 . . 4.13 . . 4.14 . . 4.15 . . 4.16 . . 4.17 . . 4.18 . . 4.19 . . 4.20
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTRODUCTION Correspondence clause of ISO 9001:2000 Written by:
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INTRODUCTION This manual provides a written description of the organization and policies of the quality system. Changes may be made to this manual only after being approved by the manager of quality assurance or an authorized representative. The system is designed to provide controls to assure that product quality meets or exceeds the quality requirements and expectations of our customers. The system is designed to provide controls for the prevention of nonconforming parts, early detection of discrepancies, and corrective action to ensure consistent delivery of a quality product. The contents of this manual r efer to inter national standard ISO 9001:2000 prepared after incorporation of corresponding changes in quality manual ISO 9002 (1994). The manual provides customer-focused leadership with continual improvement through involvement of employees within a strong communication matrix.
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SCOPE AND FIELD OF APPLICATION (Company name) is in compliance with the requirements of an international standard ISO 9002:1994 quality system — model for quality assurance in production and installation. However, the second edition (ISO 9002:1994), together with ISO 9001:1994 and ISO 9003:1994, is cancelled and replaced by a third edition of the ISO 9001:2000 module. It constitutes a technical revision of these documents. The quality manual QM-3 is prepared in accordance with the corresponding changes specified in the third edition of ISO 9001:2000. The international standard ISO 9001:2000 specifies quality system requirements for use where a contract between the company and customers requires the demonstration of capability to produce and supply the product in compliance with the applicable regulatory requirements. The sub-clause 7.3, design and/or development, is excluded. The contents and the elements of this ISO 9002 quality system manual are revised in accordance with the requirements of international standard ISO 9001:2000.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REFERENCES Correspondence clause of ISO 9001:2000 Written by:
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REFERENCES ANSI/ASQCA3, Quality Systems Terminology ISO 8402-1986, Quality Vocabulary ANSI/ASQCQ 90-1987, Quality Management and Quality Assurance Standards Guidelines for Selection and Use ISO 9000-1987, Quality Management and Quality Assurance Standard — Guides for Selection and Use ISO 9002: 1994, Quality System — Model for Quality Assurance in Production and Installation ISO 9001:2000, Quality Management System Requirements
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DEFINITIONS For the purpose of standard ISO 9001:2000, the terms and definitions given in ISO 9000 apply.
Analysis Certificate An analysis certificate is a document that gives the results of the inspection made on a representative sample taken from a product before its delivery. It must contain the results of all checks in a list approved jointly by the client and the supplier.
Auditor An auditor is a person who is qualified and authorized to perform all or any portion of a quality system audit.
Audit An audit is a systematic and independent examination to deter mine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives.
Audit Organization An audit organization is an organization that regularly conducts quality assurance management system audits to a required standard.
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Batch A batch refers to assignments of a batch of finished products to a client as a function of that client’s requirements.
Conformity Conformity refers to the state of a product satisfying specified requirements.
Documentation Documentation means any recorded or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures or results.
Documentation Level The position of a quality document in the quality assurance documentation system is its documentation level.
First Party Audits Audits carried out internally by an organization are known as first party audits.
Inspection An inspection is an examination or measurement to verify whether an item or activity conforms to a specified requirement.
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Inspectors Inspectors are appointed by the purchaser to provide advice on matters relating to the product and inspection and to verify the achievement of the quality specified.
Lead Auditor An auditor who is qualified and authorized to manage a quality system audit is a lead auditor.
Management Review A management review is a compulsory evaluation carried out by general management on the state and suitability of the quality system with respect to quality policy and new objectives resulting from the changed situation.
Nonconformity Nonconformity refers to the state of a product not satisfying specified requirements.
Organization An organization is a unit to which this international standard applies.
Provisional Auditor A provisional auditor is a person who meets all requirements for registration except for audit experience.
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Quality Quality refers to all properties and characteristics of a service that make it capable of satisfying a client’s expressed or specified needs.
Quality Audit A quality audit is a methodical and independent examination in order to determine if quality-related activities and results satisfy predetermined requirements, and if these requirements are implemented efficiently and are capable of achieving the objectives.
Quality Assurance Quality assurance refers to all predetermined and systematic actions necessary to give appropriate confidence that a product or a service satisfies given quality requirements.
Quality Control Quality control is that part of good manufacturing practice which is concerned with sampling, specifications, and testing. Organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
Quality Manual The quality manual is a document describing general measures taken by the company to ensure quality in its products or services.
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Quality Planning A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be referred to as quality plan.
Quality Policy The overall quality intentions and direction of an organization formally expressed by top management are its quality policy.
Quality (or Quality-Related) Record The quality record is the filled-in record documents proving that the quality assurance and quality control actions have been done.
Quality System The quality systems refers to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
Quality Surveillance Quality surveillance means the continued monitoring and verification of the status of procedures, methods, conditions, processes, products and services, and analysis of records in relation to stated references to ensure that specified requirements for quality are being met.
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Representative Sample A representative sample is a sample taken using a clearly defined procedure in order to obtain information about a batch.
Second Party Audits Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of products by one company from another within the same group.
Specification A specification is a document that specifies the requirements with which the product and/or material must comply.
Third Party Audits Audits of organizations undertaken by an independent certification body or similar organization are called third party audits.
Traceability Traceability refers to the capability of finding the history, use, or location of an article by means of a recorded identification.
Validation The act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produced a valid result is known as validation.
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Verification Verification is the act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements. The list is not conclusive as there are many others terms in general use or contained in various standards and quality documents.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Correspondence clause of ISO 9001:2000 Written by:
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The contents of the ISO 9002:1994 international standards are described below in correspondence with ISO 9001:2001 standards to define quality system requirements and management responsibilities. Correspondence between ISO 9002:1994 and ISO 9001:2000 Clause
1.0 2.0 3.0 4.0 4.1 4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.3 4.2 4.2.1 4.2.2 4.2.3 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.4 4.4.1
ISO 9002:1994
Scope Normative reference Definitions Quality system requirements (title only) Management responsibility (title only) Quality policy Organization (title only) Responsibility and authority Resources Management representative Management review Quality system (title) General Quality system procedures Quality planning Contract review (title only) General Review Amendment to a contract Records Design control (not applicable) General (not applicable)
ISO 9001:2000
1.0 2.0 3.0
5.1 + 5.3 + 5.4.1 5.5.1 5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 4.2.1 5.4.2 + 6.2.1 + 7.1
5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.2.2 7.2.2
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Correspondence between ISO 9002:1994 and ISO 9001:2000 (Continued) Clause
4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 4.6.3 4.6.4 4.7 4.8
ISO 9002:1994
Design and development planning (not applicable) Organizational and technical interfaces (not applicable) Design input (not applicable) Design output (not applicable) Design review (not applicable) Design verification (not applicable) Design validation (not applicable) Design changes (not applicable) Document and data control (title only) General Document and data approval and issue Document and data changes Purchasing (title only) General Evaluation of subcontractors Purchasing data Verification of purchased product Control of customer-supplied product Product identification and traceability
ISO 9001:2000
7.3.1 (not applicable) 7.3.1 (not applicable) 7.2.1 7.3.3 7.3.1 7.3.1
+ 7.3.2 (not applicable) (not applicable) + 7.3.4 (not applicable) + 7.3.5 (not applicable)
7.3.1 + 7.3.6 (not applicable) 7.3.7 (not applicable)
4.2.1 + 4.2.3 4.2.3 4.2.3
7.4.1 7.4.2 7.4.3 7.5.4 7.5.3
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Correspondence clause of ISO 9001:2000 Written by:
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Correspondence between ISO 9002:1994 and ISO 9001:2000 (Continued) Clause
ISO 9002:1994
4.9
Process control
4.10 4.10.1 4.10.2 4.10.3 4.10.4 4.10.5 4.11
Inspection and testing (title only) General Receiving inspection and testing In-process inspection and testing Final inspection and testing Inspection and test records Control of inspection, measuring, and test equipment (title only) General Control procedure Inspection and test status Control of nonconforming product (title only) General Review and dispositioning of nonconforming product Corrective and preventive action (title only) General Corrective action Preventive action Handling, storage, packaging, preservation, and delivery (title only) General
4.11.1 4.11.2 4.12 4.13 4.13.1 4.13.2 4.14 4.14.1 4.14.2 4.14.3 4.15
4.15.1
ISO 9001:2000
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 7.1 + 8.1 7.4.3 + 8.2.4 7.4.3 + 7.5.1 + 8.2.4 7.4.3 + 8.2.4 7.5.3 + 8.2.4
7.6 7.6 7.5.3
8.3 8.3
8.5.2 + 8.5.3 8.4 + 8.5.2 8.4 + 8.5.3
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Correspondence between ISO 9002:1994 and ISO 9001:2000 (Continued) Clause
4.15.2 4.15.3 4.15.4 4.15.5 4.15.6 4.16 4.17 4.18 4.19 4.20 4.20.1 4.20.2
ISO 9002:1994
Handling Storage Packaging Preservation Delivery Control of quality records Internal quality audits Training Servicing Statistical techniques (title only) Identification of need Procedures
ISO 9001:2000
7.5.5 7.5.5 7.5.5 7.5.5 7.5.1 + 7.5.5. 4.2.4 8.2.2 + 8.2.3 6.2.1 + 6.2.2 7.1 + 7.5.1 8.1 + 8.2.3 + 8.2.4 + 8.4
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY POLICY Correspondence clause of ISO 9001:2000 Written by:
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QUALITY POLICY Our policy is to meet or exceed our customer’s quality needs and expectations today and concurrently anticipate the requirements of tomorrow. Quality control and quality assurance are vital links in the production and assembly process. Quality is planned and built into every [YOUR PRODUCT HERE] made at [YOUR COMPANY NAME HERE]. Our mission is to build a relationship with our customers and suppliers to ensure that quality is never compromised Our immediate and long-term success is dependent on supplying our customers with precision machined parts and products that fully meet their needs, on time, every time, at a fair price. We know that we are not alone in this effort. We must work with our customers to get all information necessary to make sure that we can understand all their requirements. We must work with our suppliers to make sure that all purchased materials and services fully meet the requirements.
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QUALITY OBJECTIVES The quality objectives defined are measurable and consistent with the quality policy and are based on:
Customer satisfaction The role of leadership The involvement of people The business process approach A systematic approach to management Continual improvement A factual approach to decision making Mutually beneficial supplier relationship
Signature Designation of the Head of the Company
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL ORGANIZATION Correspondence clause of ISO 9001:2000 Written by:
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ORGANIZATION CHART HERE Provide an organization chart of your company. Describe departments involved, field of activity, interrelationships, definitions, and terminology used within the company. Provide information as relevant:
Company introduction Nature of products manufactured Key departments and functions Organization chart List of quality-related definitions
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESPONSIBILITY AND AUTHORITY Correspondence clause of ISO 9001:2000 Written by:
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ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY Every employee who manages, performs, or verifies work affecting quality has the responsibility, authority, and organizational freedom to:
Initiate action to prevent the occurrence of product nonconformity Identify and record any product or service problems Initiate, recommend, or provide solutions through designated channels Verify the implementation of solutions Control further processing, delivery, or installation of nonconforming product or service until the deficiency or unsatisfactory condition has been corrected
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESOURCES Correspondence clause of ISO 9001:2000 Written by:
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RESOURCES The quality assurance department is assigned the management of verification of product quality. All relevant departments are provided with adequate resources and trained personnel for the activities related to product realization including inspection, test, monitoring of the design, production, installation, and servicing of the process and/or product. Verification and audit activities are carried out by personnel independent of those having direct responsibility for the work being performed.
GENERAL The areas to maintain and enhance the product quality are identified, and for necessary competence of the employees, adequate in-house, outside training programs are conducted to satisfy these needs. The records of actions initiated are maintained.
INFRASTRUCTURE (Company name) ensures the conformity of product requirements by the customers and provides adequate infrastructure in terms of workplace, area, utilities, processing equipment, computers, and means of transportation.
MANAGEMENT COMMITMENT The management has ensured its commitment by providing availability of skilled resources and communication of quality policies and objectives to the employees to meet customer and regulatory requirements. Efforts are made for continual improvement to ensure customer satisfaction.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REPRESENTATIVE Clause — 4.1.2.3, ISO 9002:1994 Correspondence clause of 5.5.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
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MANAGEMENT REPRESENTATIVE The [quality assurance manager] is the management representative and has the defined authority and responsibility for ensuring that the requirements of all pertinent standards are implemented, verified, and maintained.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3, Revision 0 ISO 9002:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
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MANAGEMENT REVIEW The entire quality system is reviewed every quarter-year through management reviews to ensure continuing suitability and effectiveness. The data and results of the reviews are recorded and maintained. (Company name) has appointed an ISO-9002 system coordinator (management representative) who is independent and has defined authority to verify the product quality. The periodic management reviews ensure continuing suitability, adequacy, and effectiveness of the overall quality system, including assessment of areas for improvement, changes in existing policies, and objectives for further improvement.
REVIEW INPUT The agenda of the management review meetings is based on follow-up actions from previous reviews, proposed and planned changes to inculcate further improvement, customer feedback resulted through effective communication and results of the previous audits, and the corrective and preventive action taken.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3, Revision 0 ISO 9002:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
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REVIEW OUTPUT The decisions made lead to provide adequate resources in terms of buildings, equipment, utilities, and communication means to ensure customer requirements are met on a continuous basis.
CONTINUAL IMPROVEMENT The application of an effective quality system supported with quality policies, objectives, reviews, and corrective action ensures continual improvement and adds value to the customer product. The product offered meets the expectations and needs of the “user” and “the pr oduct” is continuously maintained to the prescribed standard/specification/contact/order agreement.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
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GENERAL This manual documents the quality system, which is based on the exclusion of clause 7.3, revised in accordance with international standard ISO 9001:2000. It is implemented throughout the company and understood at all levels. The entire system is reviewed at least once a year by management reviews to ensure that the system is effective. The system is designed to ensure that: Products meet or exceed customer expectations. Emphasis is placed on problem presentation rather than dependent on detection after occurrence. Causes of the problem are found and comprehensive corrections are made. Feedback is generated to be used for product and process design. Constant improvement of the product and process is enhanced.
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Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
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The quality system responsibilities are tabulated in Table 1. Amend the table as relevant your company. Table 1
ISO-9002 Clause*
4.1
Management responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control (not applicable)
Correspondence clause ISO 9001:2000
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
5.1 + 5.3 + 5.4.1 + 5.5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 + 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 5.4.2 + 6.2.1 + 7.1 5.2 + 7.2.1 + 7.2.2 + 7.2.3
X * * * * * * * * * * *
7.2.1, (7.3.1 + 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7)
– – – – – – – – – – – –
* X * * * * * * * * * *
* * * * * – – – – * X *
(not applicable)
4.5
Document and data control
4.2.1 + 4.2.3
* * * * * * * X * * * *
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Correspondence clause of ISO 9001:2000 Written by: Date Supersedes
Date Issue
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mm/dd/yyyy
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Table 1 (Continued)
ISO-9002 Clause*
4.6
Purchasing
4.7
Control of customersupplied product Product identification and traceability Process control
4.8
4.9
4.10
Inspection and testing
4.11
Inspection, measurement, and test equipment Inspection and test status Control of nonconforming product
4.12 4.13
Correspondence clause ISO 9001:2000
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.4.1, 7.4.2, 7.4.3 7.5.4
* * – * * – – * X – – *
7.5.3
* * X * * – – * * * * *
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 7.1 + 8.1 + .4.3 + 8.2.4 + 7.5.1 + 7.5.3 7.6
– * X * – – – * – * – –
– X * * – – – – – * – –
7.5.3
– X * * – – – * – * – –
8.3
* * * X * * – * * * * *
– X – * – – – – – – – –
– * * * – X – * – * – –
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
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mm/dd/yyyy
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Table 1 (Continued)
ISO-9002 Clause*
4.14 4.15
4.16 4.17 4.18 4.19 4.20
Corrective actions Handling storage, packaging, preservation, and delivery Quality records Internal quality audits Training Servicing (not applicable) Statistical techniques
Correspondence clause ISO 9001:2000
8.5.2 + 8.5.3 8.4 7.5.5 + 7.5.1
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
* X * * * * * * * * * *
– * * * * – – – – * – X 4.2.4 8.2.2 + 8.2.3
* * * X * * * * * * * * * X * * * * – * * * * *
6.2.1 + 6.2.2 7.1 + 7.5.1
* X * * * * X * * * * * * * * * * – – * * * X *
8.1 + 8.2.3 + 8.2.4 + 8.4
* X * * – – – – – * – –
X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, – NOT APPLICABLE Key: ADM PRD SHP PDL PAC MPM
= = = = = =
Administration (Management) Production Shipping Product Development Lab Packaging Materials Planning Manager
QUA QCD PER PUR MKT MAI
= = = = = =
Quality Assurance Quality Control Department Personnel Purchase Marketing Maintenance
The elements not relevant are described as “not applicable."
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 5 of 7
QUALITY SYSTEM PROCEDURES The procedures required by this international standard are identified, documented, and maintained to ensure system integrity and continuous effectiveness and improvement. The documentation is maintained both in physical and electronic form as suitable to the company’s operations.
CONTROL MANUAL The quality manual describes in detail the scope and justifi cation for any exclusions made and the reference to the documented procedures established and maintained. The quality manual and procedures further describe the interactions between the elements of the quality management system.
MANAGEMENT COMMITMENT The quality policy, objectives, and supporting procedures are implemented, and the top management ensures their effectiveness through periodic reviews and effective communication.
QUALITY OBJECTIVES Measurable quality objectives are defined to meet the customer-focused requirements at relevant applicable levels within the company.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
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Page 6 of 7
DOCUMENTATION An adequate documentation level is established to ensure compliance to this international standard. The documentation includes: Quality policy/manual Standard operating procedures Applicable formats used for planning, operations, and in-process control Product technical dossier Electronic records
IMPLEMENTATION All quality system procedures and instructions are implemented to ensure effectiveness of the quality management system. To ensure continual improvement, facilities, equipment, and documents are reviewed and approved for implementation. The compatibility of the process with the production facilities and infrastructure is ensured to achieve product realization in compliance with the customer requirements. The implementation is achieved through: Planning of product realization Determination of requirements related to the product Communication
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9002:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 7 of 7
QUALITY PLANNING The elements of quality planning are based on quality objectives. The changes to the management system are maintained proactively.
PLANNING OF PRODUCT REALIZATION Planning of product realization exclusively addresses requirements of the quality management system (see 4.1). The company has determined the following as appropriate:
Customer-related processes Determination of requirements related to product Review of requirements related to the product Customer communication Design and development (if applicable) Design and development planning (if applicable) Design and development inputs (if applicable) Design and development outputs (if applicable) Design and development review (if applicable) Design and development verification (if applicable) Design and development validation (if applicable) Control of design and development changes (if applicable)
Module D: Permissable exclusions Sub-clause 7.3: design and/or development
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTRACT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3, Revision 0 ISO 9002:1994 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CONTRACT REVIEW Every order, when received, is checked to ensure that the specifics of the order are the same as what was specified at the time of quotation. When there is any discrepancy or the order is not the same as the tender, the discrepancy will be reconciled before any work is done. Before production begins, every order is checked to ensure that all pertinent information is available to the production.
CUSTOMER FOCUS (Company name) ensures to identify, determine, and meet the customer requirements.
DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT The product requirements are defined and resolved if different from those previously ordered. The records of reviews are maintained. The changes made are communicated and reconfirmed.
CUSTOMER COMMUNICATION (Company name) has determined and implemented effective communication procedures regarding product information and feedback regarding customer complaints.
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9002:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 2
GENERAL Not applicable/justify.
DESIGN AND DEVELOPMENT PLANNING Not applicable/justify.
DESIGN INPUT Not applicable/justify.
DESIGN OUTPUT Not applicable/justify.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9002:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 2 of 2
DESIGN REVIEW Not applicable/justify.
DESIGN AND DEVELOPMENT REVIEW Not applicable/justify.
DESIGN VERIFICATION Not applicable/justify.
DESIGN VALIDATION Not applicable/justify.
DESIGN CHANGES Not applicable/justify.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENT AND DATA CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5, ISO 9002:1994 4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL The organization has defined, documented, and implemented the procedures needed to ensure effective planning, operational controls, and the associated processes. The key elements include quality policy, objectives, and the applicable procedures.
DOCUMENT AND DATA APPROVAL AND ISSUES The documents are reviewed for their adequacy before approval. The document control system is designed to ensure that the information used in the production of the product or parts is clear, complete, correct, and current. No changes can be made without authorization. The system operates within a contractual constraint that requires all products or parts to be built to blueprints, drawings, or other specifications. All personnel are required to immediately report any discrepancy to the proper supervisor so that corrective action can be taken. Documentation shall include one or more of the following, but is not limited to:
Drawings Blueprints Inspection instructions Work instructions Operation sheets Test procedures Operational procedures Quality assurance procedures Formulations Common practices
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENT AND DATA CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5, ISO 9002:1994 4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
DOCUMENT AND DATA CHANGES Product and document changes are reviewed to verify that there is no degradation of quality. Document changes are distributed at the proper time to the appropriate point in the system to ensure that work and functions are accomplished in accordance with requirements.
Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6, ISO 9002:1994 7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL The purchasing system is designed to ensure that purchased material conforms to specified requirements.
VENDOR ASSESSMENT Vendors are approved based on their performance as to the type of product and service being purchased. An approved vendor’s list is kept. One or more of the following data are used for basis of approval:
Demonstrated capability Demonstrated performance Documented quality system Test reports or certifications
PURCHASING DATA Purchasing documents are reviewed for adequacy of specified requirements prior to release. Purchasing documents contain data clearly describing the product ordered, including, where applicable: The verification requirements and reports on the material for release and shipment The type, class, grade, or other precise identification The title or other positive identification and applicable issues of specifications, drawings, process requirements, inspection instructions, or other relevant technical data The title, number, and issue date of the quality system standard to be applied to the product
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6, ISO 9002:1994 7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
VERIFICATION OF PURCHASED PRODUCT Strict control of nonconforming purchased material is maintained and information is fed back to purchasing and the vendor for corrective action. The customer or our customer representative is afforded the right to verify at the source or upon receipt that the purchased product conforms to the specified requirements. At any stage of production, the customer or our customer representative is afforded access to our location to verify product conformance and, when necessary, is accommodated with verification personnel and equipment.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER-SUPPLIED PRODUCT Clause — 4.7, ISO 9002:1994 Correspondence clause of 7.5.4 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
CUSTOMER-SUPPLIED PRODUCT The products received from the customers are verified, stored, and maintained to prevent deterioration or loss. The conditions of handling and use of customer-supplied product are spelled out in the contract or by other documented specifications. Any customer-supplied product that becomes nonconforming is segregated from the production stream, recorded, and reported to the customer.
Reference Procedure — [Number ISO-4.7, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRODUCT IDENTIFICATION AND TRACEABILITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.8, ISO 9002:1994 7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRODUCT IDENTIFICATION Products and parts are identified to all applicable drawings, specifications, or other documents throughout all stages of production and delivery. For identification, suitable means are used throughout the product realization and with reference to monitoring and measurement requirements.
PRODUCT TRACEABILITY When traceability is specified, the product or parts have unique identification.
Reference Procedure — [Number ISO-4.8, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROCESS CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9, Revision 0 ISO 9002:1994 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
PROCESS CONTROL Production operations are planned and verified to ensure that they are proceeding under controlled conditions in the specified manner and sequence. Before production begins, all tooling, filtering, programming, inspection equipment, and procedures are verified. Production operations are controlled by blueprints, drawings, documented work instructions, specifications, formulations, or proven numerical controlled software. Work instructions are sufficiently detailed to accomplish the task. Where applicable, they include one or more of the following:
Function to be performed Sequence of operations Inspection points Equipment and tools, their set-up, speeds, feed, and processes Raw material types and size Blueprints, drawing number and revision number Sketches or working drawings Specifications Formulations
The above must be explicit, clear, accurate, and to the current revision level. Common practices that apply during production are documented and controlled.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROCESS CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9, Revision 0 ISO 9002:1994 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
SPECIAL PROCESSES Special process control (of processes that have parameters that affect product characteristics and may not be easily or economically measured by normal in-process or final inspection and test, or that may exhibit inferior performance only after use) will be by one or more of the following: Periodic verification of the accuracy and variability of the equipment used in making the product, e.g., welder settings Periodic verification of the continuing capabilities of the operators to meet specific quality requirements, e.g., welder certification Periodic verification of the environment, time, temperature, or other factors affecting quality, e.g., time at temperature of annealing, hardening, or heat-treating
PLANNING OF PRODUCTION REALIZATION (Company name) plans and develops the processes needed for product realization and ensures availability of infrastructure and suitable work environment. Quality objectives as appropriate to the company’s product and services are defined. Records are maintained to demonstrate that the resulting product fulfills the customer’s contractual requirements to ensure customer satisfaction.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9002:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL Inspection is used at appropriate points in the production process to ensure conformity of the product or parts. A receiving inspection is performed on incoming material, where applicable, to ensure that the incoming material conforms to requirements. Inspection is performed to the degree and extent needed to determine acceptability. In-process inspection is employed at appropriate points in the process. The quality plan or an inspection plan specifi es the type of inspection. Inspection points may include, but are not limited to one or more of the following:
Setup and first piece inspection Inspection by machine operator Inspection by automatic gages or automatic test equipment Fixed inspection stations at intervals throughout the process Patrol inspection by an inspector following an established procedure or inspection plan Inspections after specified production operations have been performed Final inspection and test, as appropriate, are performed to ensure product and part requirements. Final inspection may be one or more of the following:
First article inspection Acceptance sampling According to a quality plan 100% inspection
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9002:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
RECEIVING INSPECTION AND TEST The incoming materials are inspected to ensure compliance with the materials specification. The nonconforming materials are rejected. The facility is provided to the customers to perform specific verification test at the company premises.
IN-PROCESS INSPECTION AND TESTING The in-process inspection and testing is carried out in accordance with the approved test methods, work instructions, and qualified equipment. For in-process control, statistical sampling techniques are used as appropriate.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9002:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
FINAL INSPECTION AND TESTING The finished product compliance is ensured in accordance with customer specifications. Where possible, quality plans are used and records are maintained.
INSPECTION AND TEST RECORDS The records of inspection and testing are maintained to ensure that the finished product meets the customer specifications.
IDENTIFICATION AND TRACEABILITY Throughout product realization, the product identification and traceability are ensured using appropriate means.
Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION, MEASURING, AND Clause — 4.11, TEST EQUIPMENT ISO 9002:1994 Correspondence clause of 7.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
INSPECTION, MEASURING, AND TEST EQUIPMENT Measuring tools and gages are of the type, range accuracy, and precision appropriate to the product, parts, and process. The calibration system ensures that the measuring and test equipment is calibrated, adjusted, repaired, or replaced prior to becoming inaccurate. Procedures are in place to ensure that the measurement and inspection processes are in a state of control, and that the uncertainties associated with the measurement are suitably small, so as to have a negligible effect on decisions or actions based on inspection results or measurements. Measuring and test equipment, tooling masters, gages, jigs, and fixtures used to control manufacturing or as a media of inspection are: Proven accurate prior to use Calibrated periodically or prior to use to master standards traceable to the NIST (National Institute for Standards and Technology) Uniquely identified and, where practical, marked with calibration status Stored in a restricted area with appropriate control of environment, issuance, and recall Segregated and identified when out of adjustment, calibration, or obsolete When inspection, measuring, or test equipment is found to be out of calibration, an evaluation is made to determine the validity of previous inspection or test results and a decision is made as to the need for reinspection or retest.
Reference Procedure — [Number ISO-4.11, dated mm-dd-yyyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TEST STATUS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.12, ISO 9002:1994 7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INSPECTION AND TEST STATUS The inspection and test status of the product or parts are clearly identified by marking, tags, labels, inspection records, test reports, shop travelers, physical location, or other suitable means that indicate the conformance or nonconformance of the product. Records show the inspection authority that determined the status.
Reference Procedure — [Number ISO-4.12, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF Clause — 4.13, NONCONFORMING PRODUCT ISO 9002:1994 Correspondence clause of 8.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
CONTROL OF NONCONFORMING PRODUCT Nonconforming material is positively identified and controlled. Nonconforming material is: Identified with a clear mark such as a “hold” or “reject” tag or stamp Segregated from the work stream or placed in a designated holding area; when practical, the access is restricted to those with authority to make disposition
NONCONFORMITY REVIEW AND DISPOSITION Nonconforming product is reviewed by authorized personnel to make disposition and request corrective action. The product is resubmitted through the regular inspection channels for acceptance, if approved for release because of “rework” or a “use as is with waiver” disposition.
Reference Procedure — [Number ISO-4.13, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CORRECTIVE ACTION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14, ISO 9002:1994 8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION When nonconformances occur, the corrective action plan is activated. Anyone seeing the need for corrective action is responsible for reporting the problem to the proper supervisor or manager. Merely correcting the particular unsatisfactory product does not achieve corrective action. If possible, the root cause of the unsatisfactory condition is determined, and a proposed remedy is put in place. The effectiveness of the corrective action is verified. Corrective actions may include any or all of the following, according to the situation: Investigating the cause of the nonconforming product or service and the remedy needed to prevent recurrence Analyzing all processes, work operations, concessions, quality records, and customer complaints to detect and eliminate potential causes of nonconforming product or service Taking preventive actions to deal with problems to the level corresponding to the risk encountered Applying controls to ensure that corrective actions are taken and that they are effective Recording changes in procedures resulting in the remedy
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL HANDLING, STORAGE, PACKING, AND DELIVERY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.15, ISO 9002:1994 7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKING, AND DELIVERY The product is handled, stored, packaged, preserved, and delivered in such a way to prevent damage or deterioration through all processes including delivery of the product to the final destination.
Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY RECORDS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.16, ISO 9002:1994 4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS Quality records are maintained to demonstrate achievement of the required quality and the effectiveness of the quality system. Quality records are: Legible and identifiable to the product involved Stored and maintained in such a way that they are readily retrievable Stored in facilities that minimize deterioration and prevent loss Made available for evaluation to the customer’s representative for an agreed upon period Retained for a period of three (3) years after the work is completed, or such a period as agreed on by the customer Stored as electronic data where practical.
Reference Procedure — [Number ISO-4.16, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTERNAL QUALITY AUDITS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.17, ISO 9002:1994 8.2.2 + 8.2.3
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INTERNAL QUALITY AUDITS Quality audits are performed to evaluate the effectiveness of the quality system as well as the level of product conformance. Quality audits are:
Scheduled on the basis of the status and importance of the activity Used to determine the effectiveness of the quality system or activity. Planned, to be sure that the audit itself is effective Documented and reviewed with the personnel responsible for the area being audited Not complete until adequate corrective action is taken, when necessary Conducted using ISO 10011 as guidelines
Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TRAINING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.18, ISO 9002:1994 6.2.1 + 6.2.2
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TRAINING Consistent training is used to meet the needs of and provide training for all personnel-performed activities affecting quality. All personnel are provided with training on good quality performance and are aware of the consequences of poor quality.
Reference Procedure — [Number ISO-4.18, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SERVICING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.19, ISO 9002:1994 7.1 + 7.5.1
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SERVICING Where servicing is specified in the contract, procedures are established and maintained for performing and verifying that the service meets the specified requirements.
Reference Procedure — [Number ISO-4.19, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL STATISTICAL TECHNIQUES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.20, Revision 0 ISO 9002:1994 8.1 + 8.2.3 + 8.2.3 + 8.4 Checked by:
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STATISTICAL TECHNIQUES The need for the use of statistical techniques is determined for each job. When statistics are needed, instructions are made available at the work location. Good quality engineering practices are in place before statistical techniques are started.
Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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Appendix III Reference SOPs Subject
Quality management systems requirement (title only) Scope General Application Normative reference Terms and definitions Quality management system (title only) General requirements Documentation requirements (title only) General
Clauses ISO 9001:2000
Ref. SOP No.
1.0 1.1 1.2 2.0 3.0 4.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
4.1 4.2
ISO-4.2 ISO-4.2 ISO-4.5
New New New
mm/dd/yy mm/dd/yy mm/dd/yy
4.2.1
ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.1
New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
5.0
ISO-4.1 ISO-4.2
New New
mm/dd/yy mm/dd/yy
5.1
New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
New
mm/dd/yy
Quality manual Control of documents Control of quality records Management responsibility (title only) Management commitment Customer focus Quality policy Planning (title only)
4.2.2 4.2.3 4.2.4
5.2 5.3 5.4
Quality objectives
5.4.1
Quality management system planning Responsibility, authority, and communication (title only)
5.4.2
ISO-4.1 ISO-4.2 ISO-4.3 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.2
5.5
ISO-4.1
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Appendix III Reference SOPs (Continued) Clauses ISO 9001:2000
Ref. SOP No.
Responsibility and authority Management representative Internal communication Management review (title only) General Review input Review output Resource management (title only) Provision of resources Human resources (title only)
5.5.1
ISO-4.1
New
mm/dd/yy
5.5.2
ISO-4.1
New
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5.5.3
ISO-4.1
New
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5.6
ISO-4.1
New
mm/dd/yy
5.6.1 5.6.2 5.6.3 6.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
6.1 6.2
General
6.2.1
Competence, awareness, and training Infrastructure Work environment Product realization (title only)
6.2.2
ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.16 ISO-4.1 ISO-4.2 ISO-4.16
New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Planning of product realization
7.1
Customer-related processes (title only) Determination of requirements related to the product
7.2
ISO-4.9 ISO-4.9 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.2 ISO-4.9 ISO-4.10 ISO-4.3 ISO-4.4 ISO-4.3
New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Subject
6.3 6.4 7.0
7.2.1
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Appendix III Reference SOPs (Continued) Subject
Review of requirements related to the product Customer communication Design and development (title only) Design and development planning (not applicable) Design and development inputs (not applicable) Design and development outputs (not applicable) Design and development review (not applicable) Design and development verification (not applicable) Design and development validation (not applicable) Control of design and development changes (not applicable) Purchasing (title only) Purchasing process EP = Exclusion Permitted
Clauses ISO 9001:2000
Ref. SOP No.
Revision No.
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3
ISO-4.3
New
mm/dd/yy
7.3
ISO-4.4
New
mm/dd/yy
7.3.1
EP
EP
EP
7.3.2
EP
EP
EP
7.3.3
EP
EP
EP
7.3.4
EP
EP
EP
7.3.5
EP
EP
EP
7.3.6
EP
EP
EP
7.3.7
EP
EP
EP
7.4 7.4.1
ISO-4.6 ISO-4.6
New New
mm/dd/yy mm/dd/yy
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Appendix III Reference SOPs (Continued) Clauses ISO 9001:2000
Ref. SOP No.
Purchasing information Verification of purchased product Production and service provision (title only)
7.4.2
ISO-4.6
New
mm/dd/yy
7.4.3
Control of production and service provision
7.5.1
Validation of processes of production and service provision Identification and traceability
7.5.2
ISO-4.6 ISO-4.10 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 ISO-4.9
New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis, and improvement (title only) General
7.5.4 7.5.5
ISO-4.8 ISO-4.10 ISO-4.12 ISO-4.7 ISO-4.15
New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
7.6
ISO-4.11
New
mm/dd/yy
8.0
ISO-4.10 ISO-4.17 ISO-4.20
New New New
mm/dd/yy mm/dd/yy mm/dd/yy
8.1
Monitoring and measurement (title only)
8.2
Customer satisfaction
8.2.1
ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10
New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Subject
7.5
7.5.3
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Appendix III Reference SOPs (Continued) Clauses ISO 9001:2000
Ref. SOP No.
Internal audit Monitoring and measurement of processes Monitoring and measurement of products Control of nonconforming product Analysis of data
8.2.2 8.2.3
ISO-4.17 ISO-4.9 ISO-4.17 ISO-4.20 ISO-4.1 ISO-4.2 ISO-4.10 ISO-4.13
New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Improvement (title only) Continual improvement Corrective action Preventive action
8.5
ISO-4.14 ISO-4.20 ISO-4.1
New New New
mm/dd/yy mm/dd/yy mm/dd/yy
8.5.1
ISO-4.1
New
mm/dd/yy
8.5.2 8.5.3
ISO-4.14 ISO-4.14
New New
mm/dd/yy mm/dd/yy
Subject
8.2.4
8.3
8.4
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YOUR COMPANY NAME HERE QUALITY ASSURANCE DEPARTMENT QUALITY SYSTEMS MANUAL MODEL - 4 ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9003 MANUAL Written by:
Checked by:
Approved by:
Date Supersedes
Date Issued
Manual Serial No.
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QM-4
DISTRIBUTED TO 1) Managing Director 2) Quality Assurance 3) Marketing 4) ISO Company Representative 5) 6)
Revision No: 0 CONTROLLED COPY NO. Copy-1 Copy-2 Copy-3 Master
Reasons for Revision: mm/dd/yy 1) First time issued for (your company name)
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TABLE OF CONTENTS QUALITY SYSTEMS MANUAL REFERS TO ISO 9001:2000 PREPARED AFTER INCORPORATION OF CHANGES IN ISO 9003 QUALITY MANUAL Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . Scope and Field of Application . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . Definitions . . . . . . . . . . . . . . . . . . . . . . . . . Quality Management System . . . . . . . . . . . Quality Policy . . . . . . . . . . . . . . . . . . . . . . Organization . . . . . . . . . . . . . . . . . . . . . . . Responsibility and Authority. . . . . . . . . . . . Resources . . . . . . . . . . . . . . . . . . . . . . . . . Management Representative . . . . . . . . . . . . Management Review . . . . . . . . . . . . . . . . . Quality System. . . . . . . . . . . . . . . . . . . . . . Contract Review. . . . . . . . . . . . . . . . . . . . . Design Control (not applicable) . . . . . . . . . Document and Data Control . . . . . . . . . . . Purchasing (not applicable) . . . . . . . . . . . . Customer-Supplied Product . . . . . . . . . . . . Product Identification and Traceability . . . . Process Control (not applicable) . . . . . . . . Inspection and Testing . . . . . . . . . . . . . . . . Inspection, Measuring, and Test Equipment Inspection and Test Status . . . . . . . . . . . . . Control of Nonconforming Product . . . . . . Corrective Action . . . . . . . . . . . . . . . . . . . . Handling, Storage, Packing, and Delivery . . Quality Records . . . . . . . . . . . . . . . . . . . . . Internal Quality Audits . . . . . . . . . . . . . . . . Training . . . . . . . . . . . . . . . . . . . . . . . . . . . Servicing (not applicable). . . . . . . . . . . . . . Statistical Techniques . . . . . . . . . . . . . . . . . Appendix IV (Reference SOPs)
Clauses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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. . .0.0 . . .1.1 . . .2.0 . . .3.0 . . .4.0 . 4.1.1 . .4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 . 4.1.3 . . .4.2 . . .4.3 . . .4.4 . . .4.5 . . .4.6 . . .4.7 . . .4.8 . . .4.9 . . 4.10 . . 4.11 . . 4.12 . . 4.13 . . 4.14 . . 4.15 . . 4.16 . . 4.17 . . 4.18 . . 4.19 . . 4.20
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTRODUCTION Correspondence clause of ISO 9001:2000 Written by:
Clause — 0.0, ISO 9003:1994 0.0
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INTRODUCTION This manual provides reference to the organizational quality management system to ensure consistency, reproduceability, and continuous improvement in the company’s operations with a particular reference to customer satisfaction and to meet regulatory requirements as appropriate. The manual refers to the elements of international standard ISO 9001:2000 incorporated in the already existing ISO 9003 (1994) quality manual.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SCOPE AND FIELD OF APPLICATION Correspondence clause of ISO 9001:2000 Written by:
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SCOPE AND FIELD OF APPLICATION The international standard ISO 9003:1994 was established by Technical Committee ISO/TC 178, and is based on British standard 5750:1987 series, European standard EN 29000: 1987 series, and international standards ISO 9000:1987 series. The standard was adopted by the company to provide objective evidence that the company’s operations of final product inspection and testing are in compliance with the requirement of this standard. However, this third edition canceled and replaced the second edition (ISO 9003:1994). The quality manual QM-4 is revised in accordance with the corresponding changes specified in the third edition of ISO 9001:2000 to specify quality system requirements for use where a contract between the company and customer requires the demonstration of capability of final product inspection and testing with customer satisfaction. The permissible exclusions are made to: Sub-clause Sub-clause Sub-clause Sub-clause Sub-clause Sub-clause Sub-clause
7.1 7.2.3 7.3 7.4 7.5.1 7.5.2 7.5.3
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL REFERENCES Correspondence clause of ISO 9001:2000 Written by:
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REFERENCES ANSI/ASQCA3, Quality Systems Terminology ISO 8402-1986, Quality Vocabulary ANSI/ASQCQ 90-1987, Quality Management and Quality Assurance Standards Guidelines for Selection and Use ISO 9000-1987, Quality Management and Quality Assurance Standard — Guides for Selection and Use ISO 9003:1994, Quality System — Model for Quality Assurance in Final Inspection and Test ISO 9001:2000 module, Quality Management System Requirements
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DEFINITIONS Correspondence clause of ISO 9001:2000 Written by:
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DEFINITIONS For the purpose of standard ISO 9001:2000, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed in the quality systems manual and applicable standard operating procedure to reflect the vocabulary currently used. The term “organization” is replaced by the term “supplier” used in ISO 9001:1994, and refers to the unit to which this international standard applies. Also, the term “supplier” is replaced by the term “subcontractor.” Throughout the text of this quality systems manual and applicable procedures the term “product” also means “service.”
ANALYSIS CERTIFICATE An analysis certificate is a document that gives the results of the inspection made on a representative sample taken from a product before its delivery. It must contain the results of all checks in a list approved jointly by the client and the supplier.
AUDITOR An auditor is a person who is qualified and authorized to perform all or any portion of a quality system audit.
Audit An audit is a systematic and independent examination to deter mine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
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Audit Organization An organization that regularly conducts quality assurance management system audits to a required standard is known as an audit organization.
Batch Batch refers to assignments of a batch of finished products to a client as a function of that client’s requirements.
Conformity Conformity refers to the state of a product satisfying specified requirements.
Documentation Documentation is any recorded or pictorial information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results.
Documentation Level The position of a quality document in the quality assurance documentation system is its documentation level.
First Party Audits Audits carried out internally by an organization are called first party audits.
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Inspection An inspection is an examination or measurement to verify whether an item or activity conforms to a specified requirement.
Inspectors Inspectors are appointed by the purchaser to provide advice on matters relating to the product and inspection and to verify the achievement of the quality specified.
Lead Auditor A lead auditor is an auditor who is qualified and authorized to manage a quality system audit.
Management Review Management review is a compulsory evaluation carried out by general management on the state and suitability of the quality system with respect to quality policy and new objectives resulting from the changed situation.
Nonconformity Nonconformity refers to the state of a product not satisfying specified requirements.
Organization An organization is a unit to which this international standard applies.
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Provisional Auditor A person who meets all requirements for registration except for audit experience is a provisional auditor.
Quality Quality refers to all properties and characteristics of a service that make it capable of satisfying a client’s expressed or specified needs.
Quality Audit A quality audit is a methodical and independent examination in order to determine if quality-related activities and results satisfy predetermined requirements, and if these requirements are implemented efficiently and are capable of achieving the objectives.
Quality Assurance Quality assurance refers to all predetermined and systematic actions necessary to give appropriate confidence that a product or a service satisfies given quality requirements.
Quality Control Quality control is that part of good manufacturing practice concerned with sampling, specifications, and testing. Its organization, documentation, and release procedures ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
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Quality Manual A quality manual is a document describing general measures taken by the company to obtain quality in its products or services.
Quality Planning A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project, or contract can be referred to as quality plan.
Quality Policy The overall quality intentions and direction of an organization formally expressed by top management are its quality policy.
Quality (or Quality-Related) Record The quality record refers to the filled-in record documents proving that the quality assurance and quality control actions have been done.
Quality System The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management comprise the quality system.
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Quality Surveillance Quality surveillance refers to the continued monitoring and verification of the status of procedures, methods, conditions, processes, products and services, and analysis of records in relation to stated references to ensure that specified requirements for quality are being met.
Representative Sample A representative sample is a sample taken using a clearly defined procedure in order to obtain information about a batch.
Second Party Audits Second party audits are audits of suppliers or potential suppliers undertaken directly by a purchasing organization including the purchase of products by one company from another within the same group.
Specification The specification is a document that specifies the requirements with which the product and/or material must comply.
Supplier The supplier is the organization or company.
Subcontractor Any organization offering goods or services to the supplier is called a subcontractor.
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Third Party Audits Third party audits are audits of organizations undertaken by an independent certification body or similar organization.
Traceability Traceability is the capability of finding the history, use, or location of an article by means of a recorded identification.
Validation Validation is the act of checking a calculation or design through its stages to verify that the assumptions made, input data, and method used have produced a valid result.
Verification Verification is the act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services, or documents conform to specified requirements. The list is not conclusive as there are many other definitions in general use or contained in various standards and quality documents.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY MANAGEMENT SYSTEM Clause — 4.0, ISO 9003:1994 Correspondence clause of 4.0 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 4
The contents of the ISO 9003:1994 international standards are described below in correspondence with ISO 9001:2001 to define quality system requirements and management responsibilities. The permissible exclusions are grouped in a bracket and indicated as “not applicable.” Correspondence between ISO 9003:1994 and ISO 9001: 2000 Clause
1.0 2.0 3.0 4.0
ISO 9003:1994
4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.3 4.2 4.2.1 4.2.2 4.2.3
Scope Normative reference Definitions Quality system requirements (title only) Management responsibility (title only) Quality policy Organization (title only) Responsibility and authority Resources Management representative Management review Quality system (title) General Quality system procedures Quality planning
4.3 4.3.1 4.3.2
Contract review (title only) General Review
4.3.3
Amendment to a contract
4.1
ISO 9001:2000
1.0 2.0 3.0
5.1 + 5.3 + 5.4.1 5.5.1 5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 4.2.1 5.4.2 + 6.2.1 + (7.1, not applicable)
5.2 + 7.2.1 + 7.2.2 + (7.2.3, not applicable) 7.2.2
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Date Issue
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Revision 0
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Correspondence between ISO 9003:1994 and ISO 9001: 2000 Clause
4.3.4 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.5 4.5.1 4.5.2 4.5.3 4.6 4.6.1 4.6.2 4.6.3 4.6.4
ISO 9003:1994
Records Design control (not applicable) General (not applicable) Design and development planning (not applicable) Organizational and technical interfaces (not applicable) Design input (not applicable) Design output (not applicable) Design review (not applicable) Design verification (not applicable) Design validation (not applicable) Design changes (not applicable) Document and data control (title only) General Document and data approval and issue Document and data changes Purchasing (not applicable) General (not applicable) Evaluation of subcontractors (not applicable) Purchasing data (not applicable) Verification of purchased product (not applicable)
ISO 9001:2000
7.2.2
(7.3.1, not applicable) (7.3.1, not applicable) 7.2.1 + (7.3.2, not applicable) (7.3.3, not applicable) (7.3.1 + 7.3.4, not applicable) (7.3.1 + 7.3.5, not applicable) (7.3.1 + 7.3.6, not applicable) (7.3.7, not applicable)
4.2.1 + 4.2.3 4.2.3 4.2.3
(7.4.1, not applicable) (7.4.2, not applicable) (7.4.3, not applicable)
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Date Issue
mm/dd/yyyy
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Revision 0
Approved by: Page 3 of 4
Correspondence between ISO 9003:1994 and ISO 9001: 2000 Clause
4.7
ISO 9003:1994
4.9
Control of customer-supplied product Product identification and traceability Process control (not applicable)
4.10 4.10.1 4.10.2 4.10.3
Inspection and testing (title only) General Receiving inspection and testing In-process inspection and testing
4.10.4 4.10.5 4.11
Final inspection and testing Inspection and test records Control of inspection, measuring, and test equipment (title only) General Control procedure Inspection and test status Control of nonconforming product (title only) General Review and dispositioning of nonconforming product Corrective and preventive action (title only) General Corrective action
4.8
4.11.1 4.11.2 4.12 4.13 4.13.1 4.13.2 4.14 4.14.1 4.14.2
ISO 9001:2000
7.5.4 7.5.3 8.2.3 + 6.3 + 6.4 + (7.1 + 7.5.1 + 7.5.2, not applicable) 8.1 + (7.1, not applicable) (7.4.3, not applicable) + 8.2.4 (7.4.3 + 7.5.1, not applicable) + 8.2.4 7.4.3 + 8.2.4 7.5.3 + 8.2.4
7.6 7.6 (7.5.3, not applicable)
8.3 8.3
8.5.2 + 8.5.3 8.4 + 8.5.2
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Date Issue
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Correspondence between ISO 9003:1994 and ISO 9001: 2000 Clause
4.14.3 4.15
4.15.1 4.15.2 4.15.3 4.15.4 4.15.5 4.15.6 4.16 4.17 4.18 4.19 4.20 4.20.1 4.20.2
ISO 9003:1994
Preventive action Handling, storage, packaging, preservation, and delivery (title only) General Handling Storage Packaging Preservation Delivery Control of quality records Internal quality audits Training Servicing (not applicable) Statistical techniques (title only) Identification of need Procedures
ISO 9001:2000
8.4 + 8.5.3
7.5.5 7.5.5 7.5.5 7.5.5 7.5.5 + (7.5.1, not applicable) 4.2.4 8.2.2 + 8.2.3 6.2.1 + 6.2.2 (7.1 + 7.5.1, not applicable) 8.1 + 8.2.3 + 8.2.4 + 8.4
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY POLICY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.1, ISO 9003:1994 5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
QUALITY POLICY (Company name) management has defined and documented its policy and objectives for, and commitment to, quality. (Company name) has ensured that this policy is understood, implemented, and maintained at all levels in the organization. We believe that this approach is essential for the company in the long term. Moreover, with the support of trained and motivated personnel, this objective will enable us to continue making progress. The management believes in the effectiveness of a quality assurance system based on complying with the provisions of ISO 9003 and our principle of continual progress through defect prevention and improvement. This system is managed by our quality assurance department, whose role is to implement and maintain a structure and control its evolution in order to: Adapt our organization to satisfy existing standards and modify it whenever necessary Write the necessary procedures and manuals, then keep them up to date Perform personnel qualification and keep it updated with time Ensure that personnel are qualified and provide further training according to our plan Correct omissions by corrective and preventive actions and monitor their effectiveness
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Clause — 4.1.1, ISO 9003:1994 5.1 + 5.3 + 5.4.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
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Quality Objectives It is ensured that quality objectives, including those needed to meet requirements for product compliance, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy.
Signature Designation of the Head of the Company
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL ORGANIZATION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2, ISO 9003:1994 Title (only)
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
ORGANIZATION CHART HERE Provide an organogram of your company. Provide a brief history of the company, the products and services offered by the company, and the departments responsible. Provide a brief history of the company. Provide a summary of services and products provided by the company. Describe the key departments involved and their functions in brief. Provide an organogram. Provide definitions of quality-related terms used in the manual and applicable procedures.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESPONSIBILITY AND AUTHORITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.1, ISO 9003:1994 5.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
ORGANIZATIONAL RESPONSIBILITY AND AUTHORITY The responsibility, authority, and the interrelation of all personnel who manage, perform, and verify work affecting quality are defined in the applicable standard operating procedures. The quality has been defined, particularly for personnel who need the organizational freedom and authority to: Verify the implementation of solutions through audits Identify and record products or services associated quality problems Provide solutions through designated channels Initiate and recommend corrective action to prevent the occurrence of product nonconformity Demonstrate control over further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL RESOURCES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.2.2, ISO 9003:1994 5.1 + 6.1 + 6.2.1 + 6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
RESOURCES (Company name) has identified in-house verification requirements, provided adequate resources, and assigned trained personnel for verification activities (see 4.18). Verification activities include inspection, test, and monitoring of the design production, installation, and servicing of the process and/or product; and design reviews and audits of the quality system, process, and/or products to be carried out by personnel independent of those having direct responsibility for the work being performed. For verification activities, the organization critically follows the requirements specified for the competence, awareness, and training for personnel performing quality-related work who may affect the end results. The actions taken are reviewed for their effectiveness.
INFRASTRUCTURE The provisions for buildings, equipment, and personnel are determined and provided as appropriate to the company’s operations.
MANAGEMENT COMMITMENT Top management is committed to meeting the customer and regulatory requirements. Systematic and structured planning ensures identification and availability of resources, implementation of quality policy throughout the organization, and achievement of management objectives in a timely manner without compromising customer requirements.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REPRESENTATIVE Clause — 4.1.2.3, ISO 9003:1994 Correspondence clause of 5.5.2 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
MANAGEMENT REPRESENTATIVE (Company name) has appointed a management representative who, irrespective of other responsibilities, has defined authority and responsibility for ensuring that the requirements of this standard are implemented and maintained.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3, Revision 0 ISO 9003:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
MANAGEMENT REVIEW The quality system in place is reviewed annually and, when necessary, is subject to management reviews to ensure continuing suitability and effectiveness. The data and results of the reviews are recorded and maintained.
REVIEW INPUT The management reviews are conducted with a planned agenda to provide direction for the company’s quality operations. Input fr om outside and inside sources are welcome to ensure continuous improvement. The audit findings and areas of quality concern are discussed. It is ensured that corrective and preventive measures are taken on time. The review input includes statistical evaluation of process performance and product conformity.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL MANAGEMENT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.1.3, Revision 0 ISO 9003:1994 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
REVIEW OUTPUT The decisions made in the management review committee meetings are followed to ensure: Infrastructure and resources availability Review of customer requirements Continuous improvement and effectiveness of the documented system
CONTINUAL IMPROVEMENT The quality policies, objectives, and documented pr ocedures are reviewed at specified frequency, and corrective actions are initiated to ensure continual improvement based on audit findings and review of analytical data.
Reference Procedure — [Number ISO-4.1, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 8
GENERAL (Company name) has established and maintained a documented quality system as a means of ensuring that the product conforms to specified requirements. This includes: The clarification of standards of acceptability for all features and requirements, including those that contain a subjective element The identification of any measurement requirement involving capability that exceeds the known state-of-the-art in sufficient time for the needed capability to be developed The identification and acquisition of any controls, processes, inspection equipment, fixtures, total production resources, and skills that may be needed to achieve the required quality The preparation of documented quality system procedures and instructions in accordance with the requirements of this standard The preparation of quality plans and a quality manual in accordance with the specified requirements The updating, as necessary, of quality control, inspection, and testing techniques, including the development of new instrumentation The effective implementation of the documented quality system procedures and instructions The responsibilities in the quality system are described in Table 1. Amend the table as relevant to your company. Permissible exclusions are marked as “not applicable.”
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
Page 2 of 8
mm/dd/yyyy
mm/dd/yyyy
The quality planning matrix is described in Table 1. Table 1
ISO 9001 Clause
4.1
Management responsibilities
4.2
Quality system
4.3
Contract review
4.4
Design control (not applicable)
4.5
Document and data control
Correspondence Clause ISO 9001:2000
5.1 + 5.3 + 5.4.1 + 5.5.1 + 6.1 + 6.2.1 + 6.3 + 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 5.4.2 + 6.2.1 + (7.1, not applicable) 5.2 + 7.2.1 + 7.2.2 + (7.2.3, not applicable) 7.2.1, (7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 7.3.5 + 7.3.6 + 7.3.7, not applicable) 4.2.1 + 4.2.3
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
X * * * * * * * * * * *
* X * * * * * * * * * *
* * * * * – – – – * X *
– – – – – – – – – – – –
* * * * * * * X * * * *
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
Page 3 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
Correspondence Clause ISO 9001:2000
4.6
Purchasing
4.7
Control of customersupplied product 7.5.3 (not Product identification and applicable) traceability Process control 6.3 + 6.4 + 7.1 (not applicable) + (7.5.1, not applicable) + 7.5.2 + 8.2.3 Inspection and 7.1 + 8.1 (not testing applicable) 7.4.3. + (not applicable) 7.5.1 (not applicable) 7.5.3 (not applicable) 8.2.4
4.8
4.9
4.10
7.4.1 (not applicable) 7.4.2 (not applicable) 7.4.3 (not applicable) 7.5.4
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
* * – * * – – * X – – *
– X – * – – – – – – – –
* * X * * – – * * * * *
– * X * – – – * – * – –
– X * * – – – – – * – –
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Correspondence clause of ISO 9001:2000 Written by: Date Supersedes
Date Issue
Page 4 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
4.11
4.12 4.13
4.14 4.15
4.16 4.17 4.18 4.19
Inspection, measurement, and test equipment Inspection and test status Control of nonconforming product Corrective actions Handling, storage, packaging, preservation, and delivery Quality records Internal quality audits Training Servicing (not applicable)
Correspondence Clause ISO 9001:2000
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
7.6
– * * * – X – * – * – –
7.5.3 (not applicable) 8.3
– X * * – – – * – * – –
8.5.2 + 8.5.3 8.4 7.5.5 + 7.5.1 (not applicable)
* X * * * * * * * * * *
4.2.4 8.2.2 + 8.2.3
* * * X * * * * * * * * * X * * * * – * * * * *
6.2.1 + 6.2.2 7.1 + 7.5.1 (not applicable)
* X * * * * X * * * * * * * * * * – – * * * X *
* * * X * * – * * * * *
– * * * * – – – – * – X
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
Page 5 of 8
mm/dd/yyyy
mm/dd/yyyy
Table 1 (Continued)
ISO 9001 Clause
4.20
Statistical techniques
Correspondence Clause ISO 9001:2000
8.1 + 8.2.3 + 8.2.4 + 8.4
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Element in the Quality System
* X * * – – – – – * – –
X RESPONSIBLE FUNCTIONS, * FUNCTIONS CONCERNED, – NOT APPLICABLE Key: ADM PRD SHP PDL PAC MPM
= = = = = =
Administration (Management) Production Shipping Product Development Lab Packaging Materials Planning Manager
QUA QCD PER PUR MKT MAI
= = = = = =
Quality Assurance Quality Control Department Personnel Purchase Marketing Maintenance
CONTROL MANUAL The quality system manual provides descriptions of management efforts and initiatives to ensure customer requirements are met with continuous improvement in the final product inspection and testing activities. The quality system manual and procedures: Provide a documented system that contr ols the activity/service/product Produce written procedures that define authority, responsibility, and interfaces Ensure that the activity/service/product meets all specified customer requirements
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 6 of 8
Promote a reputation in the marketplace through customer satisfaction Provide a system to ensure that all nonconformities, errors, deficiencies, complaints, and quality problems are immediately identified, controlled, and dealt with through feedback loops Promote efficiency and cost effectiveness Motivate staff toward pride in carrying out their jobs Promote improved industrial relations through interfaces and interdepartmental cooperation and input Control all activity/service/product performance data through feedback analysis Provide activity/service/product performance data through feedback analysis Identify and control training needs Show commitment to quality through maintaining constant quality levels Improve communications Produce historical records to confirm levels of quality system effectiveness and activity/service/product achievement Provide information for employee induction
MANAGEMENT COMMITMENT (Company name) has identified and assigned a management representative to ensure quality policies are established with due consideration to customer focus. Management reviews are conducted to ensure that the defined objectives are met.
QUALITY OBJECTIVES The quality objectives are well defined to prevent defects or errors occurring during the whole process and to prevent failure of the end product.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 7 of 8
DOCUMENTATION Documentation plays an important role in the effective control and implementation of quality management system requirements. The quality policy, objective, and applicable procedures ensure to meet:
Mark a well-defined purpose or need Comply with applicable standards and specifications Meet regulatory requirements Satisfy users’/customers’ expectations Supply a product that is totally fit for use
Documents that need to be controlled are:
The quality manual Control procedures Work instructions, including work orders and route cards Quality plans Drawings — including “as built” Specifications Inspection and test plans or requirements (usually included in work instructions and quality plans) Records (inspection, quality, training, document control, calibration, and goods accepted and dispatched) Purchasing specifications, orders, and acknowledgments Quotes, tenders, contracts, and contract reviews Audit plans and records Management reviews
The quality records are identified, established, and maintained.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY SYSTEM Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.2, Revision 0 ISO 9003:1994 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 4.2.1 + 5.4.2 + 6.2.1 + 7.1 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 8 of 8
IMPLEMENTATION Top management takes all necessary actions to implement the requirement of this international standard with a particular focus on customer requirements.
The processes needed to achieve excellence are implemented. Interaction and interfaces are identified. Training needs are fulfilled. Actions resulting from the management reviews are communicated and implemented. Sequences of interaction affecting the product quality are defined and documented.
QUALITY PLANNING The quality system requirements specified in clause 4.1 are achieved through proactive planning. Changes made to the system are documented and controlled.
PLANNING OF PRODUCTION REALIZATION Quality plans are made specific to the product, project, or contract as appropriate to the company’s operations. The records of quality plans are maintained and include: Determination of requirements related to the product Review of requirements related to the product
Reference Procedure — [Number ISO-4.2, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTRACT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3, ISO 9003:1994 5.2 + 7.2.1 + 7.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
CONTRACT REVIEW (Company name) has established and maintained procedures for contract review and for the coordination of these activities. Each contract is reviewed to ensure that: The requirements are adequately defined and documented. Any requirements differing from those in the tender are resolved. The ability of the supplier to meet contractual requirements is ensured. The contract review activities, interfaces, and communication within the supplier’s organization are coordinated with the purchaser’s (clients) organization, as appropriate.
CUSTOMER FOCUS Appropriate methods including statistical techniques are used to monitor the customer requirements and their fulfillment.
DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT The product requirements are reviewed before the contract or tender is accepted. Product requirements are defined and communicated to the personnel responsible for the quality production. The unresolved and ambiguous issues are resolved and documented. The changes made in the product specifications are approved before execution of the order. Provisions are made for removing absolute drawings, procedures, work instructions, and specifications from all work areas to ensure that they are correctly authorized versions. Provisions are made for emergency changes necessary to prevent the production of nonconforming material.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTRACT REVIEW Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.3, ISO 9003:1994 5.2 + 7.2.1 + 7.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
CUSTOMER COMMUNICATON The product information is determined and communicated at all levels as appropriate, including customer complaints, changes, revisions, and final approvals.
Reference Procedure — [Number ISO-4.3, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9003:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 1 of 2
GENERAL Not applicable/justify.
DESIGN AND DEVELOPMENT PLANNING Not applicable/justify.
DESIGN INPUT Not applicable/justify.
DESIGN OUTPUT Not applicable/justify.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DESIGN CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.4, Revision 0 ISO 9003:1994 7.2.1 + 7.3.1 + 7.3.2 + 7.3.3 + 7.3.4 + 7.3.5 + 7.3.6 + 7.3.7 Checked by: Approved by:
Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Page 2 of 2
DESIGN REVIEW Not applicable/justify.
DESIGN AND DEVELOPMENT REVIEW Not applicable/justify.
DESIGN VERIFICATION Not applicable/justify.
DESIGN VALIDATION Not applicable/justify.
DESIGN CHANGES Not applicable/justify.
Reference Procedure — [Number ISO-4.4, dated mm-dd-yyyy]
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OUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL DOCUMENT AND DATA CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.5, ISO 9003:1994 4.2.1 + 4.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
DOCUMENT, DATA APPROVAL, AND ISSUES The procedure is established and maintained to control all documents and data that relate to the requirements of this standard. These documents are reviewed and approved for adequacy by authorized personnel prior to issue. This control ensures that: Obsolete documents are promptly removed from all points of issue or use. The pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed.
DOCUMENT AND DATA CHANGES Changes to documents are reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise. The designated organizations have access to pertinent background information upon which to base their review and approval. Where practicable, the nature of the changes is identified in the document or the appropriate attachments. A master list is established to identify the current revision of documents in order to preclude the use of nonapplicable documents. Documents are reissued after a practical number of changes have been made.
Reference Procedure — [Number ISO-4.5, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PURCHASING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.6, ISO 9003:1994 7.4.1 + 7.4.2 + 7.4.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
GENERAL Not applicable/justify.
VENDOR ASSESSMENT Not applicable/justify.
PURCHASING DATA Not applicable/justify.
VERIFICATION OF PURCHASED PRODUCT Not applicable/justify.
Reference Procedure — [Number ISO-4.6, dated mm-dd-yyyy]
285
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CUSTOMER SUPPLIED PRODUCT Clause — 4.7, ISO 9003:1994 Correspondence clause of 7.5.4 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
CUSTOMER-SUPPLIED PRODUCT (Company name) has established and maintained procedures for verification, storage, and maintenance of purchaser (client) supplied product provided for incorporation into the supply. Any such product that is lost, damaged, or is otherwise unsuitable for use is recorded and reported to the purchaser (see 4.16). Verification by the supplier does not absolve the purchaser of the responsibility to provide an acceptable product.
Reference Procedure — [Number ISO-4.7, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PRODUCT IDENTIFICATION AND TRACEABILITY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.8, ISO 9003:1994 7.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PRODUCT IDENTIFICATION The procedure has been established and maintained for identifying the product from applicable drawing specifications, or other documents, during all stages of production, delivery, and installation.
PRODUCT TRACEABILITY Where, and to the extent that, traceability is a specified requirement, individual products or batches have a unique identification. This identification is recorded (see 4.16).
Reference Procedure — [Number ISO-4.8, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL PROCESS CONTROL Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.9, Revision 0 ISO 9003:1994 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
PROCESS CONTROL Not applicable/justify.
SPECIAL PROCESSES Not applicable/justify.
PLANNING OF PRODUCTION REALIZATION Not applicable/justify.
Reference Procedure — [Number ISO-4.9, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9003:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
GENERAL RECEIVING INSPECTION AND TESTING The incoming products are not used or processed (except in the circumstances described in 4.10.2.3) until they have been inspected or otherwise verified as conforming to specified requirements. Verification is performed in accordance with the quality plan or documented procedures. Where incoming product is released for urgent production purposes, it is positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformance to specified requirements. In determining the amount and nature of the receiving inspection, consideration is given to the control exercised at the source, and documented evidence of quality conformance is provided.
IN-PROCESS INSPECTION AND TESTING Nonconforming product is identified. Hold the product until the required inspection and tests have been completed or necessary reports have been received and verified, except when the product is released under positive recall procedures (see 4.10.1). Release under positive recall procedures does not preclude the inspection, testing, and identification of the product as required by the quality plan or documented procedures. Product conformance is established to specified requirements by use of process monitoring and control methods. (Company name) inspects, tests, and identifies the product as required by the quality plan or documented procedures.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TESTING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.10, Revision 0 ISO 9003:1994 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2 Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
FINAL INSPECTION AND TESTING The quality plan or documented procedures for final inspection and testing require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out and that the data meet specified requirements. (Company name) carries out all final inspection and testing in accordance with the quality plan or documented procedures to complete the evidence of conformance of the finished product to the specified requirements. No product is dispatched until all the activities specified in the quality plan or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.
INSPECTION AND TEST RECORDS (Company name) establishes and maintains records that give evidence that the product has passed inspection and/or test with defined acceptance criteria (see 4.16).
IDENTIFICATION AND TRACEABILITY The identification and traceability is maintained to ensure product recall in the event of nonconformity or for rework.
Reference Procedure — [Number ISO-4.10, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION, MEASURING, AND Clause — 4.11, TEST EQUIPMENT ISO 9003:1994 Correspondence clause of 7.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 2
INSPECTION, MEASURING, AND TEST EQUIPMENT (Company name) controls, calibrates, and maintain inspection, measuring, and test equipment, whether owned, on loan, or provided by the client, to demonstrate the conformance of the product to the specified requirements. Equipment is used in a manner that ensures that measurement uncertainty is known and is consistent with the r equired measurement capability. (Company name): Assesses and documents the validity of previous inspection and test results when inspection, measuring, and test equipment is found to be out of calibration Maintains calibration records for inspection, measuring, and test equipment (see 4.16) Identifies inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status Ensures that the inspection, measuring, and test equipment is capable of the accuracy and precision necessary Establishes, documents, and maintains calibration procedures, including details of equipment type, identification number, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory Identifies, calibrates, and adjusts all inspection, measuring, and test equipment and devices that can affect product quality at prescribed intervals or, prior to use, against certified equipment having a known valid relationship to nationally recognized standards. Where no such standards exist, the basis used for calibration is documented.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION, MEASURING, AND Clause — 4.11, TEST EQUIPMENT ISO 9003:1994 Correspondence clause of 7.6 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 2 of 2
Identifies the measurements to be made and the accuracy required, and selects the appropriate inspection, measuring, and test equipment Ensures that the environmental conditions are suitable for the calibrations, measurements, and tests being carried out Ensures that the handling, preservation, and storage of inspection, measuring, and test equipment is such that the accuracy and fitness for use is maintained Safeguards inspection, measuring, and test facilities, including both test hardware and test software, from adjustments that would invalidate the calibration setting. Where test hardware (e.g., jigs, fixtures, templates, patterns) or test software are used as suitable forms of inspection, they are checked to prove that they are capable of verifying the acceptability of the product prior to release for use during production and installation and are rechecked at prescribed intervals. The extent and frequency of such checks is established, and records are maintained as evidence of control (see 4.16). Measurement design data are made available when required by the purchaser (client) or his/her representative for verification that the product is functionally adequate.
Reference Procedure — [Number ISO-4.11, dated mm-dd-yyyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INSPECTION AND TEST STATUS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.12, ISO 9003:1994 7.6.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INSPECTION AND TEST STATUS The inspection and test status of products is identified by using markings, authorized stamps, tags, labels, routing cards, inspection records, test software, physical location, or other suitable means to indicate the conformance or nonconformance of the product with regard to inspection and tests performed. The identification of inspection and test status is maintained, as necessary, throughout production and installation of the product to ensure that only product that has passed the required inspections and tests is dispatched, used, or installed. Records identify the inspection authority responsible for the release of conforming product (see 4.16).
Reference Procedure — [Number ISO-4.12, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CONTROL OF Clause — 4.13, NONCONFORMING PRODUCT ISO 9003:1994 Correspondence clause of 8.3 ISO 9001:2000 Written by: Checked by: Date Supersedes
Date Issue
mm/dd/yyyy
mm/dd/yyyy
Revision 0
Approved by: Page 1 of 1
CONTROL OF NONCONFORMING PRODUCT (Company name) has established and maintained procedures to ensure that product that does not conform to specified requirements is prevented from inadvertent use or installation, evaluated, segregated when practical, disposed of, and the functions concerned are notified.
NONCONFORMITY REVIEW AND DISPOSITION The responsibility for review and authority for the disposition of nonconforming product is defined. Nonconforming product is reviewed in accordance with documented procedures. It may be:
Reworked to meet the specified requirements Accepted with or without repair by concession Regraded for alternative application Rejected or scrapped
Where required by the contract, the proposed use or repair of product (see 4.13.1b) that does not conform to specified requirements is reported for concession to the purchaser or the purchaser’s (client) representative. The description of nonconformity or repairs that have been accepted is recorded to denote that actual conditions do not, in fact, conform to the acceptable standard (see 4.16). Repaired and reworked product is reinspected in accordance with documented procedures.
Reference Procedure — [Number ISO-4.13, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL CORRECTIVE ACTION Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.14, ISO 9003:1994 8.4 + 8.5.2 + 8.5.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
CORRECTIVE ACTION The procedure is established, documented, and maintained for: Implementing and recording changes in procedures resulting from corrective action Applying controls to ensure that corrective actions are taken and that they are effective Initiating preventive actions to deal with problems to a level corresponding to the risks encountered Analyzing all processes, work operations, concessions, quality records, service reports, and customer complaints to detect and eliminate potential causes of nonconforming product Investigating the cause of nonconforming product and the corrective action needed to prevent recurrence
Reference Procedure — [Number ISO-4.14, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL HANDLING, STORAGE, PACKING, AND DELIVERY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.15, ISO 9003:1994 7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 2
mm/dd/yyyy
mm/dd/yyyy
HANDLING, STORAGE, PACKAGING, AND DELIVERY General The procedure is established, documented, and maintained for handling, storage, packaging, and delivery of the product.
Handling The methods and means of handling that prevent damage or deterioration are provided for the product.
Storage The secured storage areas or stock rooms are provided to prevent damage or deterioration of the product pending use or delivery. Appropriate methods for authorizing receipt and the dispatch to and from such areas is stipulated. In order to detect deterioration, the condition of the product is assessed at appropriate intervals.
Packing The packing, preservation, and marking processes (including materials used) are controlled to the extent necessary to ensure that conformance to specified requirements is identified, preserved, and segregated for all products from the time of receipt until the responsibility ceases.
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL HANDLING, STORAGE, PACKING, AND DELIVERY Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.15, ISO 9003:1994 7.5.1 + 7.5.5
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 2 of 2
mm/dd/yyyy
mm/dd/yyyy
Delivery The arrangements are made for the protection of the quality of the product after final inspection and test. Where contractually specified, this protection is extended to include delivery to destination.
Reference Procedure — [Number ISO-4.15, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL QUALITY RECORDS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.16, ISO 9003:1994 4.2.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
QUALITY RECORDS Quality records are maintained to demonstrate achievement of the required quality and the effective operation of the quality system. Pertinent subcontractor quality records are an element of these data. The procedure is established and maintained for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. All quality records are legible and identifiable to the product involved. Quality records are stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records have been established and recorded. Where agreed contractually, quality records are made available for evaluation by the purchaser (client) or the purchaser’s representative for an agreed upon period.
Reference Procedure — [Number ISO-4.16, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL INTERNAL QUALITY AUDITS Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.17, ISO 9003:1994 8.2.2 + 8.2.3
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
INTERNAL QUALITY AUDITS The comprehensive system of planned and documented internal quality audits is carried out to verify whether quality activities comply with planned arrangements and to determine the effectiveness of the quality system. The audits and follow-up actions are carried out in accordance with documented procedures. Audits are scheduled on the basis of the status and importance of the activity. The results of the audits are documented and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area takes timely corrective action for the deficiencies found by the audits (see 4.1.3).
Reference Procedure — [Number ISO-4.17, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL TRAINING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.18, ISO 9003:1994 6.2.1 + 6.2.2
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
TRAINING The procedure is established for identifying the training needs and to provide for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks are qualified on the basis of appropriate education, training, and/or experience, as required. Appropriate records of training are maintained (see 4.16).
Reference Procedure — [Number ISO-4.18, dated mm-dd-yyyy]
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL SERVICING Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.19, ISO 9003:1994 7.1 + 7.5.1
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
SERVICING Not applicable/justify.
Reference Procedure — [Number ISO-4.19, dated mm-dd-yyyy]
301
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YOUR COMPANY NAME HERE QUALITY SYSTEMS MANUAL STATISTICAL TECHNIQUES Correspondence clause of ISO 9001:2000 Written by:
Clause — 4.20, ISO 9003:1994 8.1 + 8.2.3 + 8.4
Revision 0
Checked by:
Approved by:
Date Supersedes
Date Issue
Page 1 of 1
mm/dd/yyyy
mm/dd/yyyy
STATISTICAL TECHNIQUES Where appropriate, the procedure is established for identifying adequate statistical techniques required for verifying the acceptability of process capability and product characteristics.
Reference Procedure — [Number ISO-4.20, dated mm-dd-yyyy]
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Appendix IV Reference SOPs
Subject
Quality management systems requirement (title only) Scope General Application Normative reference Terms and definitions Quality management system (title only) General requirements Documentation requirements (title only) General
Clauses ISO 9001 :2000
Ref. SOP No.
1.0 1.1 1.2 2.0 3.0 4.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
4.1 4.2
New New New New New New New New New New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Revision No.
Issued On
Quality manual Control of documents Control of quality records Management responsibility (title only) Management commitment
4.2.2 4.2.3 4.2.4 5.0
Customer focus Quality policy Planning (title only)
5.2 5.3 5.4
Quality objectives
5.4.1
Quality management system planning Responsibility, authority, and communication (title only) Responsibility and authority Management representative Internal communication Management review (title only)
5.4.2
ISO-4.2 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.2 ISO-4.5 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.3 ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.1 ISO-4.2 ISO-4.2
5.5
ISO-4.1
New
mm/dd/yy
5.5.1 5.5.2 5.5.3 5.6
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
4.2.1
5.1
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Appendix IV Reference SOPs (Continued) Clauses ISO 9001 :2000
Ref. SOP No.
General Review input Review output Resource management (title only) Provision of resources Human resources (title only)
5.6.1 5.6.2 5.6.3 6.0
ISO-4.1 ISO-4.1 ISO-4.1 ISO-4.1
New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
6.1 6.2
General
6.2.1
Competence, awareness, and training Infrastructure Work environment Product realization (title only)
6.2.2
ISO-4.1 ISO-4.1 ISO-4.2 ISO-4.16 ISO-4.1 ISO-4.2 ISO-4.16
New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
ISO-4.9 ISO-4.9 ISO-4.2 ISO-4.9 ISO-4.10 EP
New New New New New EP
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy EP
Subject
Planning of product realization Customer-related processes (title only) Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development (title only) Design and development planning Design and development inputs Design and development outputs EP = Exclusion Permitted
6.3 6.4 7.0
7.1 7.2
Revision No.
Issued On
7.2.1
ISO-4.3 ISO-4.4 ISO-4.3
New New New
mm/dd/yy mm/dd/yy mm/dd/yy
7.2.2
ISO-4.3
New
mm/dd/yy
7.2.3 7.3
EP EP
EP EP
EP EP
7.3.1
EP
EP
EP
7.3.2
EP
EP
EP
7.3.3
EP
EP
EP
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Appendix IV Reference SOPs (Continued) Clauses ISO 9001 :2000
Ref. SOP No.
Revision No.
Issued On
Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing (title only) Purchasing process Purchasing information Verification of purchased product Production and service provision (title only)
7.3.4
EP
EP
EP
7.3.5
EP
EP
EP
7.3.6
EP
EP
EP
7.3.7
EP
EP
EP
7.4 7.4.1 7.4.2 7.4.3
EP EP EP EP
EP EP EP EP
EP EP EP EP
7.5
Control of production and service provision Validation of processes of production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices Measurement, analysis, and improvement (title only)
7.5.1
ISO-4.9 ISO-4.10 ISO-4.15 ISO-4.19 EP
New New New New EP
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy EP
7.5.2
EP
EP
EP
7.5.3 7.5.4 7.5.5 7.6
EP ISO-4.7 ISO-4.15 ISO-4.11
EP New New New
EP mm/dd/yy mm/dd/yy mm/dd/yy
8.0
ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.10 ISO-4.17 ISO-4.20 ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.20
New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
Subject
General
8.1
Monitoring and measurement (title only)
8.2
EP = Exclusion Permitted
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Appendix IV Reference SOPs (Continued)
Subject
Clauses ISO 9001 :2000
Customer satisfaction
8.2.1
Internal audit Monitoring and measurement of processes
8.2.2 8.2.3
Monitoring and measurement of products
8.2.4
Control of nonconforming product Analysis of data
8.3
Improvement (title only) Continual improvement Corrective action Preventive action
8.4 8.5 8.5.1 8.5.2 8.5.3
Ref. SOP No.
Revision No.
Issued On
ISO-4.9 ISO-4.10 ISO-4.17 ISO-4.9 ISO-4.17 ISO-4.20 ISO-4.1 ISO-4.2 ISO-4.10 ISO-4.13
New New New New New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
ISO-4.14 ISO-4.20 ISO-4.1 ISO-4.1 ISO-4.14 ISO-4.14
New New New New New New
mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy mm/dd/yy
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: MANAGEMENT RESPONSIBILITY Corresponding Clause: ISO 9001:2000
Distributed To: Written by:
SOP NO: ISO – 4.1 5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2 + 5.5.3 + 5.6 + 5.6.1 + 5.6.2 + 5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1 Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Checked by: Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE To describe the elements of management responsibility in accordance with clause 4.1 of ISO 9001 and the corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors to understand and implement management responsibilities described in the procedure. The ISO 9000 systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE MANAGEMENT RESPONSIBILITY 1. The quality management policies and objectives are stated and defined in the quality manual, numbers QM-1, QM-2, QM-3, and QM-4, respectively (select any one of these as a model). The contents described in the quality manual and applicable procedures are relevant to the size of the departments within the organization, the types of activities, the complexity of the process, and the interactions and competence of the personnel. 2. The quality policy defines measurable quality goals and relates needs/expectations, which include: Meet contractual requirements/satisfy users Comply with applicable standards and specifications Comply with the company’s standard operating procedures
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: MANAGEMENT RESPONSIBILITY Corresponding Clause: ISO 9001:2000
Distributed To: Written by:
SOP NO: ISO – 4.1 5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2 + 5.5.3 + 5.6 + 5.6.1 + 5.6.2 + 5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1 Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Checked by: Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
3. The senior company management representative authorizes the quality policy statement. 4. The responsibilities, authorities, and interrelationships of personnel are fully described (provide your company organization chart) for all quality activities in the quality manual as well as in the applicable procedures described in the quality manual appendix and other procedures applicable to your company’s operations. 5. Each procedure fully describes the purpose, responsibility, authority, and interrelationships of personnel for all quality activities. 6. The responsibilities for personnel related to quality assurance functions are defined in the job description file. 7. The responsible personnel allocated for the management and verification of the following work activities are suitably qualified: Contract review Design review System auditing/corrective action Materials control 8. The quality manual is reviewed and revised at least once a year. The master quality manual is kept with the ISO 9000 coordinator. The distribution copies are stamped with a copy number The recipients acknowledge the receipt and replacement. 9. Documents needed by the organization to ensure effective planning, operations, and control of processes are established. 10. Processes needed for the quality management system are referred to in the manual and in the applicable procedures, including processes for management activities, provision of resources, product realization, and measurement. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization ensures control over that process. Control of such outsourced processes is identified within the quality management system.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: MANAGEMENT RESPONSIBILITY Corresponding Clause: ISO 9001:2000
Distributed To: Written by:
SOP NO: ISO – 4.1 5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2 + 5.5.3 + 5.6 + 5.6.1 + 5.6.2 + 5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1 Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Checked by: Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 4
11. There is an appointed management representative quality assurance manager (ISO 9000 system coordinator), independent of other functions, with the necessary authority and responsibility to ensure that the requirements of the standard are implemented and maintained. 12. The management representative provides information to the top management relating to the performance of the quality management system. 13. The management representative is responsible for organizing the management reviews of the quality systems, e.g., every three months. 14. The management reviews are undertaken against defined/measurable goals and objectives, which incorporate: Internal audit Customer complaints Nonconformance Training Contract review 15. Records of the management reviews are maintained. 16. The management reviews take into consideration customer needs and expectations. 17. The distribution of the quality manual and standard operating procedures is controlled. 18. The terms and definitions used in the development, demonstration, and implementation of the quality system r efer to standard ISO 9000.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: MANAGEMENT RESPONSIBILITY Corresponding Clause: ISO 9001:2000
Distributed To: Written by:
SOP NO: ISO – 4.1 5.1 + 5.3 + 5.4.1 + 5.5.1 + 5.5.2 + 5.5.3 + 5.6 + 5.6.1 + 5.6.2 + 5.6.3 + 6.1 + 6.2.1 + 6.3 + 7.1 Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Checked by: Approved by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
DOCUMENTATION 1. Quality manual and applicable procedures/policy/objectives 2. Organization chart 3. Personnel qualification file (document describing the qualification and experience required for each specific quality-related job) 4. Job description file 5. Internal audit reports (system) 6. Management review minutes 7. Management action plans
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.2
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEMS Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 1 of 8
PURPOSE To describe the elements of the quality system in accordance with clause 4.2 of ISO 9001 and the corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors to understand and implement management responsibilities described in the procedure. The ISO 9000 systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE The company has established and maintained the following documented quality system as a means of ensuring that the product/services conform to specified requirements of this international standard.
QUALITY SYSTEMS 1. Top management is committed to the development and implementation of the quality management system and to continually improving its effectiveness by: Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements Establishing the quality policy Ensuring that quality objectives are established Conducting management reviews and ensuring the availability of resources
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 2 of 8
2. The quality objectives, including those needed to meet requirements for the product, are established at relevant functions and levels within the organization. The quality objectives are measurable and consistent with the quality policy. 3. The key quality management system documentation includes: Documented statements of the quality policy and quality objectives A quality manual Documented procedures required by this international standard Documents needed by the organization to ensure the effective planning, operation, and control of its processes Quality records required by this international standard 4. The distribution of quality management system documentation is controlled. The documented quality management system gives due consideration to the following elements: All resources and skills needed to achieve the required quality The compatibility of procedures and applicable documentation Updating of verification techniques and equipment Identification and development of measurement requirements that exceed present capabilities Verification during product development Defining levels of acceptable quality, including subjective standards Identification, preparation, and retention of quality records Identifying the processes needed for the quality management system and their application throughout the organization Determination of the sequence and interaction of these processes Determination of criteria and methods needed to ensure that both the operation and control of these processes are effective
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
5. 6.
7.
8.
9.
10.
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 3 of 8
Ensuring the availability of resources and information necessary to support the operation and monitoring of these processes Monitoring, measurement, and analysis of these processes and implementation of actions necessary to achieve planned results and continual improvement of these processes. The quality manual outlines the structure of the quality management system and reference procedures. The contents of the quality manual include: The scope of the quality management system, including details of and justification for any exclusions The documented procedures established for the quality management system or reference to them A description of the interaction between the processes of the quality management system The contents of the quality management system documentation differ from one department to another due to: The size of the department and type of activities The complexity of processes and their interactions The competence of personnel The procedures/work instructions are documented, describing all quality-related activities and authorities (provide details in a separate work instruction manual). The processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, and measurement. Concerning the outsourced processes that affect product conformity with requirements, the organization ensures their control and identification within the quality management system.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 4 of 8
11. The documentation is maintained both in hardware and software form as appropriate to the company’s operations. 12. Personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience. 13. The planning of the quality management system is carried out in order to meet the quality objectives, maintain the system integrity when changes to the quality management system are planned and implemented, and develop the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. 14. In planning product realization, the organization determines the following, as appropriate: Quality objectives and requirements for the product The need to establish processes and documents and provide resources specific to the product Required verification, validation, monitoring, inspection, and test activities specific to fulfill the product requirements Records needed to provide evidence that the realization processes and resulting product fulfill requirements 15. Quality plans are prepared in accordance with the requirements of the standard where applicable (provide details). 16. The output of this planning is maintained in a suitable for m according to the organization’s method of operations. 17. The responsibilities and authorities are defined in the following quality matrix in Table 1, based on the ISO 9001, ISO 9002, and ISO 9003 series of standards with a corresponding clause of international standard ISO 9001:2000. Amend the matrix to suit your company’s operations.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Based on: ANSI/ASQC Q 90011994 Checked by:
Written by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 5 of 8
RESPONSIBILITIES AND AUTHORITY IN THE QUALITY SYSTEM The quality planning matrix is described in Table 1. Table 1 REF. ISO 9002
REF. ISO 9003
Corresponding Clause ISO 9001:2000
4.1
Management responsibilities
APP
APP
4.2
Quality system
APP
APP
5.1 + 5.3 + 5.4.1 + 5.5.1 + 6.1 + 6.2.1 + 6.3 5.5.2 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 5.4.2 + 6.2.1 + 7.1 5.2 + 7.2.1 + 7.2.2 + 7.2.3 7.3.1 7.2.1 + 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7
4.3
Contract review
APP
APP
4.4
Design control
NA
NA
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Elements in the Quality System ISO 9001:1994 Clauses
X * * * * * * * * * * *
* X * * * * * * * *
* *
* * * * * – – – – * X * * * – * – – – X * – * –
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Based on: ANSI/ASQC Q 90011994 Checked by:
Written by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 6 of 8
Table 1 (Continued) Function Concerned in the Entity
REF. ISO 9002
REF. ISO 9003
Corresponding Clause ISO 9001:2000
4.5
APP
APP
4.2.1 + 4.2.3
* * * * * * * X * * * *
APP
NA
* * – * * – – * X – – *
Control of customersupplied product Product identification and traceability Process control
APP
APP
7.4.1 7.4.2 7.4.3 7.5.4
APP
APP
7.5.3
* * X * * – – * * * * *
APP
NA
– * X * – – – * – * – –
4.10
Inspection and testing
APP
APP
4.11
Inspection, measurement, and test equipment Inspection and test status Control of nonconforming product
APP
APP
6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 7.1 + 8.1 7.4.3 + 8.2.4 7.5.1 7.5.3 7.6
APP
APP
7.5.3
– X * * – – – * – * – –
APP
APP
8.3
* * * X * * – * * * * *
4.6
4.7
4.8
4.9
4.12 4.13
Document and data control Purchasing
ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Elements in the Quality System ISO 9001:1994 Clauses
– X – * – – – – – – – –
– X * * – – – – – * – –
– * * * – X – * – * – –
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Based on: ANSI/ASQC Q 90011994 Checked by:
Written by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 7 of 8
Table 1 (Continued) REF. ISO 9002
REF. ISO 9003
Corresponding Clause ISO 9001:2000
4.14
APP
APP
APP
APP
8.5.2 + 8.5.3 8.4 7.5.5 + 7.5.1
4.15
4.16 4.17
Corrective actions Handling, storage, packaging, preservation, and delivery Quality records
Function Concerned in the Entity ADM QUA PRD QCD SHP MAI PER PDL PUR PAC MKT MPM
Elements in the Quality System ISO 9001:1994 Clauses
* X * * * * * * * * * *
– * * * * – – – – * – X
APP
APP
4.2.4
APP
APP
8.2.2 + 8.2.3
4.18
Internal quality audits Training
APP
APP
6.2.1 + 6.2.2
4.19
Servicing
NA
NA
7.1 + 7.5.1
4.20
Statistical techniques
APP
APP
8.1 + 8.2.3 + 8.2.4 + 8.4
* * * X * * * * * * * * * X * * * * – * * * * * * X * * * * X * * * * * * * * * * – – * * * X * * X * * – – – – – * – –
X RESPONSIBLE FUNCTIONS * FUNCTIONS CONCERNED – NOT APPLICABLE Key: ADM PRD SHP PDL PAC MPM NA
= = = = = = =
Administration (Management) Production Shipping Product Development Lab Packaging Materials Planning Manager Not Applicable
QUA QCD PER PUR MKT APP MAI
= = = = = = =
Quality Assurance Quality Control Department Personnel Purchase Marketing Applicable Maintenance
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY SYSTEM Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.2 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1 + 5.4.2 + 6.2.1 + 7.1 Revision No.: New
Approved by: Page 8 of 8
DOCUMENTATION 1. 2. 3. 4. 5.
Quality manual Standard operating procedures/training records Work instructions manual/training records Training manual/training records Equipment manual/training records
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTRACT REVIEW SOP NO: ISO – 4.3 Corresponding Clause: ISO 9001:2000 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE To describe the elements of contract review in accordance with clause 4.3 of ISO 9001 standard and corresponding clauses of an international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of the particular departmental managers and supervisors concerned (marketing and sales) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The company has established and maintained a procedure for contract review and for the coordination of these activities. The company ensures that the following customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction. A designated and authorized staff is responsible for reviewing each contract to ensure: The requirements are adequately defined and documented. The tender, contract, order/delivery dates, and penalties are agreed upon and accepted. Verbal orders from the clients are documented and confirmed before processing. Any requirements differing from those in the tender are resolved. The capacity to meet contractual requirements is reviewed and documented.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTRACT REVIEW SOP NO: ISO – 4.3 Corresponding Clause: ISO 9001:2000 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
The appropriate departments are notified in writing of any variations in the client’s contract. Requirements specified by the customer, including the requirements for delivery and postdelivery activities, are fulfilled. Requirements not stated by the customer but necessary for specified use or known and intended use are fulfilled. 2. The company reviews the requirements related to the product. This review is conducted prior to the organization’s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that: Product requirements are defined. Contract or order requirements differing from those previously expressed are resolved. The organization has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review are maintained. 3. The review and approval arrangements include consideration of (if applicable): Program Internal resources External resources Risk factors Statutory/regulatory requirements related to the contract Project stages and reviews Documentation of project details Record of contract review Statutory and regulatory requirements related to the product
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTRACT REVIEW SOP NO: ISO – 4.3 Corresponding Clause: ISO 9001:2000 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 4
4. The work plan identifies the following elements: The client brief Principal personnel, responsibilities, and authority Other parties associated with the job Principal stages of the project, including reviews and approvals Arrangements for communication and consultation between the parties Specific project procedures, where needed The job record/filing system Final review and approval 5. The review includes any additional requirements determined by the organization. 6. Where the customer provides no documented statement of requirements, the customer requirements are confirmed by the organization before acceptance. 7. Where product requirements are changed, the organization ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. 8. In situations such as Internet sales, a formal review is impractical for each order. Instead, the review covers product information provided in the catalogues of advertising material. 9. Effective arrangements for communicating with customers are maintained, with particular reference to: Product information Inquiries, contracts, or order handling, including amendments Customer feedback, including customer complaints
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ISO 9001:2000 Document Development Compliance Manual
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTRACT REVIEW SOP NO: ISO – 4.3 Corresponding Clause: ISO 9001:2000 5.2 + 7.2.1 + 7.2.2 + 7.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
DOCUMENTATION
Purchase requisition from the clients Quotation/agreement/contract Approved purchase order Material release certificate of analysis Client acknowledgment of the goods Customer’s goods receiving reports (clients)
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
327
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300.30.4
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300.30.4
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 1 of 8
PURPOSE To describe the design control procedure in accordance with clause 4.4 of ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of the particular departmental managers or supervisors concerned (product development) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE The procedure has been established and maintained to control and verify the design of the product services in order to ensure that the specified requirements are met. Control of design is achieved through design, planning, identification of design input, verification of design, stage output, control of changes, and validation of the eventual product or service. Each phase of design is carefully controlled to ensure that it achieves the purchaser’s or product brief requirements. 1. The designing and development of the product is controlled. 2. During the design and development planning, the organization determines the following: The design and development stages The review, verification, and validation that are appropriate to each design and development stage The responsibilities and authorities for design and development
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 2 of 8
3. The personnel supervising the design development are suitably qualified/experienced. 4. The design scheme is traceable to the basis against which the design has been prepared (if applicable). The design route starts with the input of information to the design team. This input is usually referred to as the design brief. The brief may consist of information from simple verbal instructions to very detailed drawings and specifications. Information for the brief comes from marketing, sales, and customer requirements. It is very important to ensure that the brief given to the design team is transmitted formally to ensure that the design personnel are aware of the requirements. This may require several meetings with the customer to ensure that the requirements are perfectly clear prior to starting any design work. Changes to the design brief must be carefully controlled to assess their cost and effect on work completed up to the point of change. 5. The design scheme is reviewed to give due consideration to contract review actions. 6. The design and development are reviewed at regular intervals in accordance with the planned program. 7. Requirements for product development are determined and records are maintained, including functional and performance requirements, applicable statutory and regulatory requirements, where applicable, information derived from previous similar designs, and other requirements essential for design and development. 8. The requirements are complete, unambiguous, and clear. 9. The operability, maintainability, reliability, safety, interchangeability, and spare parts aspects are suitably addressed.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 3 of 8
10. The design and development responsibilities are clearly assigned. 11. The design function or team is responsible for translating the design brief into drawings and technical specifications for materials, products, processes, and services that satisfy the customer’s expectations at an acceptable cost, which reflects a return on capital invested. 12. Design tasks may be either subcontracted or carried out in-house. Whichever is chosen, management is responsible for specifically assigning tasks and responsibilities that shall include the requirements for achieving quality. 13. External design is controlled to the same extent as internal design. Design staff have the necessary qualifications, experience, training, and expertise to carry out the tasks assigned to them. This requires verification prior to assigning tasks and responsibilities. 14. Design management establishes design programs with time-phased checkpoints, which are relative to the product or service and translate the customer’s needs and marketing information into clear specifications. 15. The design program is determined by the product or service application, complexity, technology, standardization, and past proven designs compared to the risks involved. Safety, environmental, and other regulations shall be taken into account. 16. The following design factors are taken into consideration: Product application Design complexity Technology being used Degree of standardization Compatibility with proven designs Customer needs Consideration of safety requirements
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Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
17. 18.
19.
20. 21.
22. 23. 24. 25.
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 4 of 8
Environmental and other regulations The quality policy Statutory requirements The calculations, design, and drawings are rechecked. The quality assurance quality requirements are unambiguous and define the quality characteristics. Special requirements including safeguards against misuse, reliability, maintainability, and serviceability throughout reasonable life expectancy will also be considered. Product testing and measurement are specified and include: Performance target values and tolerances Acceptance/rejection criteria Test and measurement methods and equipment Computer software considerations (if used) All relevant personnel are involved with the design review of the design/functions. Participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions are maintained. The design reviews clearly indicate the scope of the review and actions decided. The actions completed are recorded. Changes to the design are documented for proposing, reviewing, approving, and implementing. At suitable stages, systematic reviews of design and development are conducted to evaluate the ability of the results of design and development to fulfill requirements, identify any problems, and propose necessary actions.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 5 of 8
26. Changes to the design include review of interfaces. 27. The interfaces between different groups involved in design and development are managed to ensure effective communication and clear assignment of responsibility. Documentation is updated, as appropriate, as the design and development progress. 28. Participants at each design review include representatives of all functions affecting quality as appropriate to the phase being reviewed. 29. The aim of each review is to ensure that the design is proceeding according to plan and is meeting the specification or customer requirements. The review may also identify and anticipate problem areas or inadequacies and initiate corrective actions. It may also review the adequacy of any corrective actions taken since the last review took place. 30. It is prudent to raise an agenda for design reviews to ensure that nothing is missed and that reviews do not overrun the time allocated to them. 31. Elements of design plans and reviews include items pertaining to customer needs and satisfaction. Comparison of purchase needs expressed in the product brief with technical specifications for materials, products, and processes Verification of design through data and calculation checks and validation of design through prototype tests, where applicable Ability to perform under expected conditions of use and environment Considerations of unintended uses and misuses Safety and environmental compatibility Compliance with regulatory requirements, national and international standards, and corporate practices
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 6 of 8
32. The technical data of the design are used to provide instruction, maintenance, and spare documentation at the production phase. 33. The materials used are standardized. 34. The information (reference literature) adequate for the scope of work is maintained. 35. After completion of design, verification is performed to ensure that the design and development outputs have satisfied the design and development input requirements. Records of the results of the verification and any necessary actions are maintained. 36. Design verification is carried out at sufficient planned stages by applying analytical evaluation or other methods to ascertain that the design stage output is achieving the design stage input requirement parameters. Methods of verification are: FMEA, failure mode and effects analysis Fault tree analysis Risk audit Inspection and test of prototypes or production samples Independent evaluation to verify original calculations or to provide alternatives and/or perform tests to produce results for comparison Adequate numbers of samples are tested to ensure statistical confidence in the results. 37. Design evaluation of performance, reliability, durability, maintainability, and safety under expected operational and storage conditions is carried out. 38. Quality control techniques are applied to ensure and verify that all design features are as intended and that any changes to the design have been authorized, distributed, accomplished, and recorded.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 7 of 8
39. The results of verification, evaluation, and tests are recorded and documented to provide evidence of conformance of the actual design to the planned design. This allows for comparison of the design input against the design output. 40. After completion, designs are validated/tested to ensure that they meet customer needs/requirements. The design outputs ar e approved prior to release to ensure that they: Satisfy customer requirements Meet the input requirements for design and development Provide appropriate information for purchasing, production, and service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its safe and proper use 41. The validation is performed in accordance with a planned arrangement to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. Wherever practicable, validation is completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions are maintained. 42. The quality system provides for a review to determine whether production capability and field support are adequate for the new or redesigned product. Depending upon the type of product, the review may cover the following points: Availability and adequacy of installation, commissioning, operation, maintenance, and repair manuals Existence of an adequate distribution and customer service organization Training of field personnel
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DESIGN CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.4 7.3.1 + 7.3.2 + 7.3.4 + 7.3.5, 7.2.1 + 7.3.3 + 7.3.6 + 7.3.7 Revision No.: New
Approved by: Page 8 of 8
Field trials (validation) Certification of satisfactory completion of qualification tests Physical inspection of early production units and their packaging and labelling Evidence of process capability to meet the specification production requirements 43. The feedback obtained from the clients is used effectively in the development of future designs.
DOCUMENTATION 1. 2. 3. 4. 5. 6. 7.
Design input (request) Design development data Design reference material Design change control form Design output form data Design verification data Product development file
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 6
PURPOSE To describe the document and data control in accordance with clause 4.5 of ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The management has defined and documented its policy and objectives for, and commitment to, quality. This policy is relevant to the organizational goals and the expectations and needs of customers. It is ensured that this policy is understood, implemented, and maintained at all levels in the organization. 2. This requirement is achieved by raising and using the following quality documentation. a. Quality Assurance Manual: A statement of company quality policy (signed by the chief executive) and a declaration of intent as to how the requirements of the nominated quality management standards are addressed. The quality assurance manual provides a description of senior and quality assurance management responsibilities and the scope of the service offered by the organization. The manual contains organization charts (organograms) and key responsibilities of senior management.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 6
b. Detailed Procedures: Provides a listing of the authorized practices, responsibilities, and interfaces to be adopted in pursuit of the company’s activities, in particular those that relate to, or follow on from, different departments. Responsibilities of middle and junior management are described. c. Work Instructions: Written instructions are used within departments and contain specific details of how particular tasks are to be carried out. These are the backbone of the quality system as they describe in great detail how “the task” is to be carried out. d. Additional Contract Procedures: These are additional procedures for specific contracts and include precise purchaser requirements, procedural matters in relation to outside organizations involved, and any additional controls required due to the nature of the task or risk factor involved. e. Quality Plans: Quality plans describe the strategy to assure the required quality at each stage of the task without disproportionate effort to produce the plan. Plans are made available early on in the project, rather than a “wallpapering” exercise at the end to suit the purchaser’s quality assurance representative. Quality plans are used in contract situations where the purchaser or his/her nominated representative wishes to control various phases of the task. They nominate hold, stop, report, and documentation points beyond which the supplier may not progress until given permission to do so. The plans are drawn up by either the purchaser or the supplier, depending on the contract or quality, and then approved. 3. Documents issued to casual users who will only use them for reference, e.g., a purchaser, client, or customer, are clearly distinguished from those issued for the controlled copy circulation as they need not be kept up to date. They are marked: “uncontrolled copy” (will not be maintained), “this copy will not be kept up to date,” or “check for latest issue before use.”
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 6
4. The documentation can be in any form or type of medium as appropriate to the company’s operations. 5. Documents required by the quality management system are controlled. Quality records are a special type of document and are controlled according to the requirements given in this international standard. 6. The status of documents is indicated in the current registers. The documents are identified by a specific number and are available at the appropriate workplaces. 7. The documents are legible and readily identifiable. 8. All of these documents are controlled, issued, and recorded. Special attention must be paid to any changes to controlled documents as lack of control can have disastrous effects at the point of use of the document. 9. A clear definition of the controls is applied and included in the procedures that govern the use of documents. This includes: Responsibility for the creation, authorization, revision, and issuing of controlled documents Formats to be used Identification of issue, revision, or amendment status Indentification of the reason for the change Instructions for removal of superseded and obsolete documents from the point of use How marking up of superseded documents if retained in use or on file is to be carried out Record keeping requirements Where computerized documents are held, procedures should specify which is the master document — the magnetic media (diskette, hard disc, or tape) or the hard copy.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
10. 11.
12.
13. 14. 15. 16. 17. 18. 19. 20.
Page 4 of 6
For most documents, these objectives are met by designating them as controlled documents, which are: Properly authorized by approved signatories Serial numbered for identification Issue/revision referenced and dated Issued within a registered circulation Subject to control of all changes Updated to same distribution Documents received from external organizations are recorded to ensure traceability. The documents affecting the product quality/services are adequately drafted, checked, and approved for adequacy prior to use. Specifications/reports QMS documents (manual and SOPs) Methods or checklists in use are adequate and complete and are referenced to the procedure number, revision number, and issue date. The same authorities that originally approved the documents review the changes to in-house documents. The changes made in the documents are documented. The reasons for changes are suitably recorded. The documents are formally issued to recipients to track their purpose and status. All recipients are kept posted with updated documents The superseded documents are withdrawn from the workplace. Master lists of documents applicable to each job are maintained by the management representative. The handling and storing of master documents is consistent with: Traceability Their preservation
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 5 of 6
21. The classified documents are kept secured. 22. The discrepancies discovered at the workplace in the documents are resolved and documented. 23. The documents are reviewed according to the specified frequency (e.g., once per year) for verification, updated as necessary, and reapproved. 24. The changes relating to subcontract materials are approved by the company. 25. The company evaluates the consequences of changes relating to subcontract materials. 26. The consequences of alterations to interchangeability and spare parts are made known to the customer. 27. The changes are reflected in: User instruction literature Spare parts lists 28. The incoming and outgoing correspondence is promptly handled and the documents are traceable. 29. The standards and customer drawings/specifications are included in the document control system. 30. To prevent the unidentified use of obsolete documents, suitable identification is assigned if they are retained for any purpose. 31. The management representative is responsible for the production, issue, and holding of documents. Table 1 provides the level and types of documents implemented in the company. 32. The documents identified as quality records are kept secured according to the shelf life determined and are easily retrievable.
Marketing Sales and Contracts Design and Development
Material Control
Manufacture, Engineering, Planning
Accounts Costing
Personnel Training
Service and After-Sales Support
Quality Records
Written Instructions To Control Taks
Company Procedures Level 2 Work Instruction/ Plans of Work Level 3 Forms, Records, Documents, Files Level 4
Statement of Policy, Commitment, Organization, and Responsiblities Company Practices, Responsibilities, and Interfaces
300.30.5
Quality Manual Level 1
Table 1 Quality Documentation Description
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: DOCUMENT AND DATA CONTROL SOP NO: ISO – 4.5 Corresponding Clause: ISO 9001:2000 4.2.1 + 4.2.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 6 of 6
DOCUMENTATION 1. SOPs distribution register 2. External and internal documents distribution register 3. Documents change control form
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PURCHASING SOP NO: ISO – 4.6 Corresponding Clause: ISO 9001:2000 7.4.1 + 7.4.2 + 7.4.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE To describe the purchasing requirement in accordance with clause 4.6 of ISO 9001 and corresponding clauses of inter national standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (purchasing) to understand and implement management r esponsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The procedure has been established and implemented to ensure that purchased product conforms to specified requirements. 2. The quality-related material requisitions are raised with material specification, describing code number, and subjective and quantitative details. Purchasing information describes the product to be purchased, including, where appropriate, requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system requirements. 3. The company ensures the adequacy of specified purchase requirements prior to their communication to the supplier. 4. The supplies and subcontractors are evaluated based on: Quality certificate from the country of origin Material certificate of analysis
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PURCHASING SOP NO: ISO – 4.6 Corresponding Clause: ISO 9001:2000 7.4.1 + 7.4.2 + 7.4.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
5.
6. 7. 8. 9.
10.
11. 12. 13. 14. 15.
Page 2 of 3
In-house checking or sample sent from the supplier or subcontractor Second party audit Formal visit to the site Audit by mail (quality questioner) It is ensured that purchased product conforms to specified purchase requirements. Criteria for selection, evaluation, and reevaluation are established. Records of the results of evaluations and any necessary actions arising from the evaluation are maintained. The procedure for the audit of suppliers and subcontractors is maintained (checklist suitable to the activity). The approved list of suppliers for products affecting quality is maintained (refer to the purchase manual). The purchase orders are issued formally and recorded. The purchase materials are listed according to class (classify as appropriate): Materials affecting the product quality Materials not affecting the product quality The type and extent of control applied to the supplier and the purchased product depends upon the effect of the purchased product on subsequent product realization or the final product. Records of the results of the review of changes in specifications and any necessary actions are maintained. The purchased products are checked against the purchase order for their identification and suitability (as appropriate). All orders identify numbers and quality of materials. The purchasing documents are reviewed for their adequacy prior to release. The materials received are inspected, verified, and documented. The products supplied by the subcontractor are verified (describe the procedure suitable for your company).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PURCHASING SOP NO: ISO – 4.6 Corresponding Clause: ISO 9001:2000 7.4.1 + 7.4.2 + 7.4.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
16. Where the organization or customer intends to perform verification at the supplier’s premises, the organization states the intended verification arrangements and method of product release in the purchasing information.
DOCUMENTATION 1. 2. 3. 4. 5. 6.
Purchase requisition Purchase order Certificate of analysis (from the supplier or manufacturer) Vendor approval records Approved vendor list Materials receiving reports
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTROL OF CUSTOMER-SUPPLIED SOP NO: ISO – 4.7 PRODUCT Corresponding Clause: ISO 9001:2000 7.5.4 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 9001 1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE To describe the control of customer-supplied product in accordance with clause 4.7 of ISO 9001 and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (stores and quality control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The goods supplied by the customer are adequately examined upon receipt (refer to the specification manual). 2. The purchaser-supplied products are kept segregated from other similar goods in storage. 3. All goods are adequately identified using a code numbering system (choose a method suitable to your company). 4. The responsibilities and duties of the customer’s personnel (coordinator) engaged in activities under company supervision relating to the contract are clearly defined (establish procedures suitable to your company and refer to the customer-supplied product manual). 5. The defects in customer-supplied product unsuitable for use in the intended product are reported to the customer and records are maintained.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTROL OF CUSTOMER-SUPPLIED SOP NO: ISO – 4.7 PRODUCT Corresponding Clause: ISO 9001:2000 7.5.4 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 9001 1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
6. The customer-supplied product (while it is under company control or being used by the company) is identified, verified, protected, and safeguarded. Any customer property lost, damaged, or otherwise found to be unsuitable for use is reported to the customer and records are maintained. 7. The lost and damaged customer-supplied products are reported to the customer and records are maintained. Customer property includes the intellectual property.
DOCUMENTATION 1. 2. 3. 4. 5. 6.
Customer-supplied product list Customer-supplied product notification form Test records Maintenance records Storage records Specification manual for customer-supplied products.
Note: Verification by the supplier does not absolve the purchaser of the responsibility to provide acceptable product.
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PRODUCT IDENTIFICATION AND SOP NO: ISO – 4.8 TRACEABILITY Corresponding Clause: ISO 9001:2000 7.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE To describe the product identification and traceability in accordance with clause 4.8 of ISO 9001 and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The materials in the stores are identified by code number and, upon receipt, are assigned specific lot number. 2. The materials are issued to the production line with specific lot numbers against a particular batch number to be manufactured. 3. Each production batch is assigned a specific batch number. 4. The identification is carried throughout the production line with a specific batch number. 5. The materials are clearly identified at dispatch and during production, processing, and installation. 6. The product status is identified with respect to monitoring and measurement requirements. 7. The customer supplied materials are controlled using specific code numbers that are traceable.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PRODUCT IDENTIFICATION AND SOP NO: ISO – 4.8 TRACEABILITY Corresponding Clause: ISO 9001:2000 7.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
8. The organization identifies, verifies, protects, and safeguards customer property provided for use or incorporation into the product by maintaining its unique identity. 9. The customer property lost, damaged, or otherwise found to be unsuitable for use is reported to the customer and records are maintained. 10. The customer property includes intellectual property. 11. The quality records are identified and are traceable with their unique identity according to SOP ISO-4.5 and ISO-4.16.
DOCUMENTATION 1. 2. 3. 4. 5. 6. 7.
Materials code list Product code list Batch number Batch processing documents Materials test reports In-process test reports Finished product test reports
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.9
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PROCESS CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.9 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Revision No.: New
Approved by: Page 1 of 4
PURPOSE To describe the process control in accordance with clause 4.9 of ISO 9001 standard and the corresponding clauses of inter national standard ISO 9001:2000.
RESPONSIBILITY This is the responsibility of all departmental managers or supervisors (production) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The company has determined, provided, and maintained the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, for example: Buildings, workspace, and associated utilities Process equipment, both hardware and software Supporting services such as transport or communication 2. The company plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. In planning product realization, the organization determines the following as adequate: Quality objectives and requirements for the product The need to establish processes and documents and provide resources specific to the product
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PROCESS CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3.
4. 5.
6.
SOP NO: ISO – 4.9 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Revision No.: New
Approved by: Page 2 of 4
Required verification, validation, monitoring, inspection, and test activities specific to fulfill product requirements. Records needed to provide evidence that the realization processes and resulting product fulfill requirements The manufacturing operations are carried out under controlled conditions as follows: Production planning is made on a monthly basis. Written procedures are followed for manufacturing. Manufacturing is performed on suitable equipment. Calibrated monitoring and measuring devices are available. The production environment is controlled if necessary, e.g., temperature and humidity. The manufacturing process is controlled using suitable, acceptable quality plans. Release, delivery, and postdelivery activities are implemented. The output of planning is maintained in a suitable form. The organization validates the process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement (for processes where deficiencies become apparent only after the product is in use or the service has been delivered). The changes made during processing are suitably identified and records are maintained. The changes are reviewed, verified, and revalidated, as appropriate, and approved before further implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and the delivered product. Records of the results of the review of changes and any necessary actions are maintained.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PROCESS CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.9 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Revision No.: New
Approved by: Page 3 of 4
7. The validation of these processes includes, as applicable: Defined criteria for review and approval of the processes Approval of equipment and qualifications of personnel Use of specific methods and procedures Requirements for records and revalidation 8. The materials are used for process evaluation and records are maintained. 9. The production manual includes: Manufacturing direction Compliance with reference standards (specifications) Compliance with codes of practice (specifications) Photographs or representative samples (if applicable) Sampling procedures 10. The inspection is performed after each work operation that affects quality, and corrective actions are initiated, as appropriate, to ensure conformity of the product. 11. Alternatively, several steps are controlled by: Monitoring process methods Equipment control Personnel involvement 12. The inspection methods and controls are corrected whenever their unsuitability is demonstrated. 13. The special processes that form a part of production or inspection are controlled. 14. The critical equipment affecting the product quality and process capability is effectively maintained.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: PROCESS CONTROL Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.9 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3 Revision No.: New
Approved by: Page 4 of 4
DOCUMENTATION Production manual.
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.10
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TESTING Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.10 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1 + 8.2.4 Revision No.: New
Approved by: Page 1 of 4
PURPOSE To describe the inspection and testing in accordance with clause 4.10 of ISO 9001 and the corresponding clauses of inter national standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (receiving inspection), in-process control, and quality control to understand and implement management responsibilities described in the procedures. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The materials received from the vendors are identified, assigned a unique lot number, and documented. 2. The incoming goods and materials ar e checked against the purchase order (or original specified requirement). If the company or its customer intends to per form verification at the supplier premises, the company states the intended verification arrangements and method of product release in the purchasing information. 3. The company identifies the product by suitable means throughout product realization. The product status with respect to monitoring and measurement is identified. The finished product identification and traceability are maintained and recorded.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TESTING Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.10 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1, 8.2.4 Revision No.: New
Approved by: Page 2 of 4
4. The incoming goods are inspected or tested and recorded against the approved specifications. 5. The nonconforming goods or materials are marked, segregated, and subsequently issued against a concession or returned for replacement. 6. In addition to product realization, the company determines the following as appropriate to their activities: Quality objectives and requirements for the product The need to establish processes and documents and provide resources specific to the product Required verification, validation, monitoring, inspection, and test activities specific to fulfill product requirements Records needed to provide evidence that the realization processes and resulting product fulfill requirements in any suitable form 7. At each workstation, the documented procedures and/or work instructions are available for in-process inspection. 8. The in-process inspection is carried out according to the approved statistical sampling plans and acceptance criterias to: Demonstrate conformity of the product Ensure conformity of the quality management system and continually improve the effectiveness of the quality management system 9. The company plans and carries out production and service provision under controlled conditions. Controlled conditions include, as applicable: The availability of information that describes the characteristics of the product The availability of work instructions
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TESTING Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
10. 11. 12.
13. 14.
15.
16.
SOP NO: ISO – 4.10 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1, 8.2.4 Revision No.: New
Approved by: Page 3 of 4
The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement and the implementation of release, delivery, and postdelivery activities The nonconforming items are suitably identified by labels and removed from the work area. The nonconformances are immediately reported to the authority responsible for their review. The nonconformances brought about by machine malfunctions or faulty machinery/test instruments are systematically rechecked, upon rectification of such malfunctions or faults, and documented. The control documents include a provision to initiate corrective action in case of noncompliance. The finished product is subject to final inspection/test to ensure that the inspection/test requirements are met (refer to finished product specifications). The finished tests include (as relevant): Procedure qualification tests Equipment qualification tests Prototype qualification tests Proof tests Commissioning test Operational tests The inspections/tests are performed in accordance with written inspection/test procedures (as relevant): Incorporate inspection/test requirements Specify acceptance limits Specify environmental conditions The instruments used for inspection and testing are properly calibrated (if applicable).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TESTING Corresponding Clause: ISO 9001:2000 Distributed To:
Written by:
Based on: ANSI/ASQC Q 90011994 Checked by:
Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.10 7.1 + 7.4.3 + 7.5.1 + 7.5.3 + 8.1, 8.2.4 Revision No.: New
Approved by: Page 4 of 4
The calibration procedures are based on the manufacturer’s manual or made in-house. The calibration records are maintained. After calibration, the instruments are labeled to indicate status (calibration performed on, by, date of calibration, and next calibration due on). The instruments that are out of calibration are labeled to indicate their status. The results of the products tested on the instruments that are out of calibration are reevaluated after the calibration. 17. The documented inspection/test results are evaluated by authorized personnel prior to the release of the products. 18. The hold points are described in inspection/test procedures and are verified by an authorized staff if necessary. 19. The inspection/test personnel are either suitably qualified, have sufficient relevant experience, or are trained to perform the task.
DOCUMENTATION 1. 2. 3. 4. 5. 6. 7. 8.
Production manual In-process control records Calibration records (as relevant) Materials receiving reports Materials specification manual Materials nonconforming records Final inspection records Equipment manual
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
SL3089_frame_300.30.10 Page 370 Monday, May 7, 2001 11:21 AM
SL3089_frame_300.30.11 Page 371 Monday, May 7, 2001 11:21 AM
300.30.11
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300.30.11
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION, MEASURING, AND TEST EQUIPMENT Corresponding Clause: ISO 9001:2000 7.6 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.11
Revision No.: New
Approved by: Page 1 of 3
PURPOSE To describe the inspection, measuring, and test equipment in accordance with clause 4.11 of ISO 9001 and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers and supervisors (maintenance) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The monitoring and measurement activities and devices needed to provide evidence of conformity are defined to ensure consistency with the requirements. 2. The measuring and test equipment and test software used for the verification of product quality are selected based on: Range Type Accuracy Precision
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION, MEASURING, AND TEST EQUIPMENT Corresponding Clause: ISO 9001:2000 7.6 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.11
Revision No.: New
Approved by: Page 2 of 3
3. The equipment used for inspection and measurement/test equipment is identified by number or serial number (as necessary). 4. The following instruments affecting the product quality are on a calibration and maintenance program (location and frequency is described): List (as relevant) 5. The initial and periodic calibration is performed against standards that are traceable to national standards or another defined calibration basis. 6. Records are maintained in order to provide evidence of calibration and maintenance status. 7. Any equipment that is found to be out of calibration is rectified. 8. In the event that any equipment is found to be out of calibration, the results of the finished products released prior to that determination are reviewed for disposition. 9. The equipment is: Adjusted or readjusted as necessary Identified to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance, and storage 10. The ability of computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed as necessary, using adequate means as appropriate.
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300.30.11
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION, MEASURING, AND TEST EQUIPMENT Corresponding Clause: ISO 9001:2000 7.6 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.11
Revision No.: New
Approved by: Page 3 of 3
DOCUMENATION 1. Equipment preventive maintenance manual/records 2. Equipment calibration manual/records 3. Out of calibration/materials disposition form Note: See ISO 10012-1 and ISO 10012-2 for guidance.
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.12
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300.30.12
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TEST STATUS SOP NO: ISO – 4.12 Corresponding Clause: ISO 9001:2000 7.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE To describe the inspection and test status in accordance with clause 4.12 of ISO 9001 standard and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (production and shipping) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The company identifies the product by suitable means throughout product realization using a specific batch number. 2. The product status with respect to monitoring and measurement is identified using the same batch number. 3. The inspection and test status of the product is identified by using markings, authorized stamps, tags, labels, routing cards, inspection records, test software, physical location, or other suitable means to indicate the conformance or nonconformance of the product with regard to inspection and tests performed. 4. The identification of the inspection and test status is maintained, as necessary, throughout the production and installation of the product to ensure that only product that has passed the required inspections and tests is dispatched, used, or installed.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TEST STATUS SOP NO: ISO – 4.12 Corresponding Clause: ISO 9001:2000 7.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 3
5. The following measures are used for checking status: Physical identification marks Transfer of identification marks Other methods (as relevant) 6. The markings are clearly applied. 7. When physical identification is not possible, other suitable methods are used and recorded (provide details). 8. The production or manufacturing documents are maintained as the product passes through various stages with specific identification, i.e., batch number. 9. The marking are posted on the finished product to indicate the positions that affect the function of the item or cause stress in the material. 10. The manufacturing records identifying the inspections and test status are maintained with a specific batch number. 11. The nonconforming items are identified by labels with a specific batch number. 12. The authorized personnel responsible for the application and removal of status markings are clearly identified. 13. The manufacturing direction is provided with literature indicating the operating status of structures, systems, and components to prevent inadvertent operation and mix-up. 14. Before the release system, all inspection and test operations are ensured to have been satisfactorily completed, and all documentary evidence is reviewed and completed with product identification and traceability. 15. The system allows for release of the product by authorized personnel under the cover of a concession with complete identification and traceability. Authorized personnel may release the products if the finished product results are satisfactory.
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300.30.12
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INSPECTION AND TEST STATUS SOP NO: ISO – 4.12 Corresponding Clause: ISO 9001:2000 7.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
DOCUMENTATION 1. 2. 3. 4.
Labeling system manual/records Production manual/records Product manual Quality control manual
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.13
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300.30.13
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTROL OF NONCONFORMING PRODUCT Corresponding Clause: ISO 9001:2000 8.3 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.13
Revision No.: New
Approved by: Page 1 of 3
PURPOSE To describe the control of nonconforming product in accordance with clause 4.13 of ISO 9001 standard and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (production and quality control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The nonconforming products are identified and segregated by labels to indicate their pending disposition. 2. The organization ensures that product that does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure. 3. The organization deals with nonconforming product in one or more of the following ways: By taking action to eliminate the detected nonconformity By authorizing its use, release, or acceptance under concession by a relevant authority and, where applicable, by the customer By taking action to preclude its original intended use or application
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTROL OF NONCONFORMING PRODUCT Corresponding Clause: ISO 9001:2000 8.3 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.13
Revision No.: New
Approved by: Page 2 of 3
4. All nonconformities have to be dealt with regardless of how important an impact they may have on the established system. It is common practice to categorize nonconformities into groups to enable the speed of reaction to their rectification to be assessed. 5. They are categorized into the following groups: 5.1 Serious: A complete system element (standard requirement) or a significant part of an element is missing or ineffective. 5.2 Requires attention: A minor lapse within the system has occurred (the human element), which can quickly be put right. Several minor lapses of the same content (incorrect issue of documentation in use in several areas) show a system breakdown and are therefore regarded as serious and upgraded as such. 6. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained. 7. The products not meeting the specification are indicated to the relevant personnel or customers in a timely manner. 8. The nonconformance report incorporates recommendations for remedial action as appropriate. 9. The measures initiated ensure timely response to the nonconformance report by authorized personnel. 10. The agreed remedial actions are promptly implemented. Rework Disposal (rejection or release with notification) 11. The documented procedures/quality plans applicable to reworked products are reviewed and approved by authorized personnel. 12. Adequate records are kept of the actions taken and the quality compliance of the item upon completion of repair/rework. 13. The reworked items are issued after adequate verification review and approval.
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300.30.13
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CONTROL OF NONCONFORMING PRODUCT Corresponding Clause: ISO 9001:2000 8.3 Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
SOP NO: ISO – 4.13
Revision No.: New
Approved by: Page 3 of 3
14. The “as built” drawings are kept when necessary or when contractually required. 15. The changes to design requirements arising from nonconformance follow the original design approval route. 16. Regarding any nonconforming product detected after delivery or use, the company takes action appropriate to the effects of the nonconformity. 17. The company strives to continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.
DOCUMENTATION 1. Nonconformance reports 2. Corrective action request forms/records 3. Rework disposition records
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.14
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300.30.14
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CORRECTIVE ACTION SOP NO: ISO – 4.14 Corresponding Clause: ISO 9001:2000 8.4 + 8.5.1 + 8.5.2 + 8.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE To describe the elements of corrective action in accordance with clause 4.14 of ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (mostly production and quality control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review 2. The company determines, collects, and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data provides information relating to: Customer satisfaction Conformance to product requirements
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CORRECTIVE ACTION SOP NO: ISO – 4.14 Corresponding Clause: ISO 9001:2000 8.4 + 8.5.1 + 8.5.2 + 8.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3.
4. 5.
6.
7.
Page 2 of 3
Characteristics and trends of processes and products including opportunities for preventive action Suppliers The records of product and system defects are analyzed to identify and eliminate potential areas of nonconformance. Nonconformance handling programs are made and followed. In the event of noncompliance, the effective corrective and preventive actions are established and documented. The company initiates actions to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions appropriate to the effects of the nonconformities encountered are taken. The nonconformity investigations include: Reviewing nonconformities (including customer complaints) Determining the causes of nonconformities Evaluating the need for action to ensure that nonconformities do not recur Determining and implementing actions needed Records of the results of actions taken Reviewing any corrective actions taken The noncompliance detected is extended for investigation and corrective action (as relevant): Within the process Within work operation/instructions Via service reports Via customer complaints The major, minor, and critical defectives that may adversely affect quality are identified and checked.
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300.30.14
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: CORRECTIVE ACTION SOP NO: ISO – 4.14 Corresponding Clause: ISO 9001:2000 8.4 + 8.5.1 + 8.5.2 + 8.5.3 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
8. The corrective action causes and resolutions taken are recorded (as appropriate). Documented evidence of individual occurrence Minutes of management meetings Changes to procedures (reason for revision) 9. The preventive actions are established to prevent recurrence and are recorded. Determining potential nonconformities and their causes Evaluating the need for action to prevent the occurrence of nonconformities Determining and implementing actions needed Records of results of actions taken and reviewing any preventive actions taken 10. The changes to procedures and other results of preventive actions are presented at management review meetings.
DOCUMENTATION 1. Nonconformance reports 2. Minutes of management reviews 3. Change control records
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.15
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: HANDLING, STORAGE, PACKAGING, SOP NO: ISO – 4.15 PRESERVATION, AND DELIVERY Corresponding Clause: ISO 9001:2000 7.5.1 + 7.5.5 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE To describe the handling, storage, packaging, and delivery in accordance with clause 4.15 of ISO 9001 and corresponding clauses of international standard ISO 9001:2001.
RESPONSIBILITY It is the responsibility of all departmental managers and supervisors (production, stores, and shipping) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The materials received and finished products are kept in a secured store to prevent damage, deterioration, and loss. Forklifts are used for transportation within the company (as relevant). The storage area is segregated, secured, temperature and humidity controlled, and provided with numbered shelves. Transport between locations and to the site is carried out in secured temperature and humidity-controlled trucks (as relevant). 2. The material’s lot number or finished product batch number is clearly identified with shelf number (location) at all times during handling, storage, and shipping, as appropriate.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: HANDLING, STORAGE, PACKAGING, SOP NO: ISO – 4.15 PRESERVATION, AND DELIVERY Corresponding Clause: ISO 9001:2000 7.5.1 + 7.5.5 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 3
3. The conformity of the product during internal processing and delivery to the intended destination is ensured. This preservation includes identification, handling, packaging, storage, and protection including constituent parts of a product. 4. The production and service provisions are carried out under controlled conditions. Controlled conditions include, as applicable: The availability of information that describes the characteristics of the product The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement, and the implementation of release, delivery, and postdelivery activities 5. The equipment used for lifting and special handling is inspected, tested, identified, and recorded. Records are kept of materials and equipment received. Storage conditions of materials and equipment are maintained where special cleanliness or environments are necessary. 6. The environmental conditions inside and outside storage areas and around equipment are periodically monitored. 7. For transportation, a temperature-controlled national delivery system is used. 8. Alternatively, companies owning temperature-controlled trucks are also used.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: HANDLING, STORAGE, PACKAGING, SOP NO: ISO – 4.15 PRESERVATION, AND DELIVERY Corresponding Clause: ISO 9001:2000 7.5.1 + 7.5.5 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
DOCUMENTATION 1. Materials receiving records 2. Materials status/location records 3. Environmental monitoring records of stores
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.16
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300.30.16
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY RECORDS SOP NO: ISO – 4.16 Corresponding Clause: ISO 9001:2000 4.2.4 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 3
PURPOSE To describe the quality records in accordance with clause 4.16 of ISO 9001 and the corresponding clause of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers and supervisors to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The quality-related records are identified and kept according to the specified shelf life and disposition procedure established. Provide a list of quality records with shelf life (as relevant). 2. The quality record may include the following (as appropriate to the company’s operations): Design records Design reviews Procurement records Commissioning and operation records Manufacturing records Inspect and test records Calibration records Control procedures Management reviews Stability records of products Material certificates
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY RECORDS SOP NO: ISO – 4.16 Corresponding Clause: ISO 9001:2000 4.2.4 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
3. 4. 5. 6.
7. 8. 9. 10.
Page 2 of 3
Nonconformance reports and concessions Corrective actions Audit plans and records Quotes, tenders, contracts, and contract review Purchasing specification Drawings Quality plans The records are traceable with the plant/material to which they relate. The records are systematically filed and are readily retrievable. The records are stored in a segregated and secured room to ensure there will be no deterioration or loss of records. The records on computers are subject to: Periodic backup Recoverable (backup is placed in a fireproof cabinet away from the workplace) The records are handled by authorized personnel to ensure security and control possible contamination with viruses Quality records are kept legible, readily identifiable, and retrievable. The records furnished are consistent with relevant codes, standards, and regulatory requirements. The records that are shipped with equipment are suitably protected. The contractual record requirements are identified and passed to appropriate organizations.
DOCUMENTATION 1. Quality records list 2. Records retrieval audit reports 3. Computer system verification records
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: QUALITY RECORDS SOP NO: ISO – 4.16 Corresponding Clause: ISO 9001:2000 4.2.4 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 3 of 3
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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300.30.17
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300.30.17
STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INTERNAL QUALITY AUDITS SOP NO: ISO – 4.17 Corresponding Clause: ISO 9001:2000 8.2.2 + 8.2.3 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 4
PURPOSE To describe the internal quality audits in accordance with clause 4.17 of ISO 9001 and corresponding clauses of inter national standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The internal audits at planned intervals determine whether the quality management system conforms to the planned arrangements of the requirements of this international standard and to the quality management system requirements established by the organization, and are effectively implemented and maintained. 2. Follow-up activities include the verification of actions taken and the reporting of verification results. The organization also applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product. 3. The company quality system is audited once every year to: Demonstrate conformity of the product Ensure conformity of the quality management system
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INTERNAL QUALITY AUDITS SOP NO: ISO – 4.17 Corresponding Clause: ISO 9001:2000 8.2.2 + 8.2.3 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 4
Continually improve the effectiveness of the quality management system Where applicable, statistical techniques are also used. 4. The main requirement of the audit team is to collect objective evidence throughout the audit task by means of interviews with the staff, examination of documents, and observation of activities and conditions at the work or site. The following methods may be used as a guideline or as appropriate to your company’s operations to achieve the “audit aim”: 4.1 Seek objective evidence that the system is functioning as prescribed. Samples taken of the system allow the audit team to obtain the required evidence. 4.2 Establish absolute proof to substantiate each nonconformity found; therefore, always seek objective evidence when nonconformity is apparent. The occurrence discovered may be the effect and not the cause. Objective evidence helps find the proof of nonconformity. 4.3 Ensure that the responsibility, authority, and interrelationships of all personnel who manage, perform, and verify work affecting quality are defined. 4.4 Ensure that each requirement (element) of the quality system is documented to demonstrate that the system covers every element/requirement and that each one is effective. 4.5 Review procedures and work instructions for completeness, adequacy, and issue levels against a master list. 4.6 Verify evidence of implementation of procedures and instructions in the work areas. The procedures and instructions are of required issue (revision), and their distribution is controlled. 4.7 Management, specialist, technician, evident staff, employee, and operator training and qualification records are evident, particularly when specialist skills are required, to ensure all employees are adequately qualified.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INTERNAL QUALITY AUDITS SOP NO: ISO – 4.17 Corresponding Clause: ISO 9001:2000 8.2.2 + 8.2.3 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
4.8
5.
6.
7.
8.
9. 10.
Page 3 of 4
Corrective actions undertaken to clear any previous nonconformities are followed up. 4.9 Work, which has been accepted, is selected at random and examined, and the findings are compared with the appropriate requirements, basis for acceptance, and applicable issue status. 4.10 Where processes are involved, the audit team should examine process controls and records to establish conformance with the specification. 4.11 Information gathered during interviews is checked by acquiring the same information from other independent sources and checking the samples against each other for accuracy. Throughout the entire audit, all the evidence collected in the form of observations should be documented on the checklist. This evidence is then examined to determine if there are any nonconformities that need to be reported. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, and methods are defined. The standard operating procedures are also audited according to the plan. Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits and for reporting results and maintaining records are defined in a documented procedure. The audits are conducted according to the checklist. The audit program includes time frame, area, and concerned responsible parties. The findings of the audit are reported, and any noncompliance found is attached to the report to initiate corrective actions and preventive measures.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: INTERNAL QUALITY AUDITS SOP NO: ISO – 4.17 Corresponding Clause: ISO 9001:2000 8.2.2 + 8.2.3 Distributed To: Based on: Revision No.: New ANSI/ASQC Q 9001-1994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 4 of 4
11. The follow-up audit is made to close the audit findings. 12. The general audit of the housekeeping is performed every six months. The findings are documented and the responsible parties are informed to initiate corrective actions. 13. The audit performed is reviewed with senior management/involved parties. 14. Recommendations are made for the resolution of problems and follow-up actions are delegated. 15. The corrective actions are closed out. 16. The results of audits are discussed during a management review meeting. 17. The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes.
DOCUMENTATION 1. SOPs audit records 2. Corrective action reports 3. Management review records
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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SL3089_frame_300.30.18 Page 401 Monday, May 7, 2001 11:25 AM
300.30.18
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: TRAINING SOP NO: ISO – 4.18 Corresponding Clause: ISO 9001:2000 6.2.1 + 6.2.2 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE To describe the training in accordance with clause 4.18 of ISO 9001 and corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. All personnel are adequately trained for the functions they perform. Personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience. 2. The training needs are effectively identified for personnel performing work affecting product quality. Qualification Previous experience Training to be provided by the equipment supplier or in-house senior staff Procedure reading is part of the training records 3. The required level of qualification and experience is defined for each quality-related job in the personnel qualification file. 4. The in-house training program is made every year and followed.
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: TRAINING SOP NO: ISO – 4.18 Corresponding Clause: ISO 9001:2000 6.2.1 + 6.2.2 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
5. The employees are sent for outside training (if necessary or as needed). 6. The training program ensures to: Provide training or take other action to satisfy these needs Evaluate the effectiveness of the action taken Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and maintain appropriate records of education, training, skills, and experience 7. The training and experience records are archived systematically and are retrievable.
DOCUMENTATION 1. Personnel qualification file 2. Employee training record 3. Annual training program
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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SL3089_frame_300.30.19 Page 405 Monday, May 7, 2001 11:25 AM
300.30.19
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: SERVICING SOP NO: ISO – 4.19 Corresponding Clause: ISO 9001:2000 7.5.1 + 7.1 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 09911994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE To describe the servicing in accordance with clause 4.19 of ISO 9001 and the corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers and supervisors to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The safety aspects of the product or service quality are identified. 2. For each product, the safety standards are identified and service provisions are made under controlled conditions. Controlled conditions include, as applicable: The availability of information that describes the characteristics of the product The availability of work instructions The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement and the implementation of release, delivery, and postdelivery activities. 3. The products are subject to safety testing as per in-house procedure (refer to the relevant procedure).
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: SERVICING SOP NO: ISO – 4.19 Corresponding Clause: ISO 9001:2000 7.5.1 + 7.1 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 09911994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
4. Safety warnings are issued to the customer. Labeling the product Within promotional literature Within maintenance or operations manuals 5. The products found to be unsafe in use are investigated by an authorized person. 6. The products are traceable by batch number and can be recalled. 7. The services provided are documented (refer to the servicing manual). 8. The service records are maintained. 9. The servicing requirements are clearly defined, reviewed, and approved by authorized personnel to ensure they have been conducted successfully. 10. The company plans and develops processes needed for product realization as appropriate to ensure customer satisfaction. Quality objectives Resources and documents required for each specific product Validation, verification, monitoring, inspection, and test activities critical for product characteristics. Documented records (for details, refer to SOP ISO-4.4).
DOCUMENTATION Servicing manual/records.
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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SL3089_frame_300.30.20 Page 409 Monday, May 7, 2001 11:26 AM
300.30.20
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: STATISTICAL TECHNIQUES SOP NO: ISO – 4.20 Corresponding Clause: ISO 9001:2000 8.1 + 8.2.3 + 8.4 + 8.2.4 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 1 of 2
PURPOSE To describe the elements of statistical technique in accordance with clause 4.20 of ISO 9001 and the corresponding clauses of international standard ISO 9001:2000.
RESPONSIBILITY It is the responsibility of all departmental managers or supervisors (production and in-process control) to understand and implement management responsibilities described in the procedure. The ISO systems coordinator (management representative) is responsible for SOP compliance.
PROCEDURE 1. The statistical analysis is performed to: Demonstrate the conformity of the product Ensure conformity of the quality management system Continually improve the effectiveness of the quality management system 2. Suitable statistical techniques are used to demonstrate the ability of the process to achieve planned results. When planned results are not achieved, correction and corrective actions are taken, as appropriate, to ensure conformity of the product. 3. The statistical analysis provides information relating to: Customer satisfaction Conformance to product requirements Characteristics and trends of processes and products including opportunities for preventive action and suppliers
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STANDARD OPERATING PROCEDURE YOUR COMPANY NAME HERE SUBJECT: STATISTICAL TECHNIQUES SOP NO: ISO – 4.20 Corresponding Clause: ISO 9001:2000 8.1 + 8.2.3 + 8.4 + 8.2.4 Revision No.: New Distributed To: Based on: ANSI/ASQC Q 90011994 Written by: Checked by: Approved by: Date Supersedes:
Date Issue:
mm-dd-yy
mm-dd-yy
Page 2 of 2
4. The areas where statistical techniques are employed are: Raw material sampling Market analysis Product design, including experiment analysis Reliability and life testing In-process control and finished product testing 5. For in-process control and determination of quality levels, inspection plans and quality control charts are used (as relevant). For sampling plans and acceptance criteria, Military Standard 105E is used. 6. The statistical analysis performed during the in-process control and finished product test is verified by other authorized personnel prior to release. 7. Product performance assessment is carried out using suitable statistical techniques as applicable. 8. The company collects and analyzes data to demonstrate the suitability and effectiveness of the system on a continuous basis to ensure: Effective internal and external communication Customer satisfaction Product meets the customer and regulatory requirements
DOCUMENTATION 1. In-process control manual/statistical analysis records 2. Statistical sampling plans 3. Product assessment records
REASONS FOR REVISION mm-dd-yy
1) First time issued for (your company name).
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SL3089_frame_300.30.20 Page 413 Tuesday, May 8, 2001 11:54 AM
SYSTEM REQUIREMENTS: Windows 95, 98, or NT 4.0 Minimum Video: 640×480 256 color display Recommended Video: 800×600 16-bit or higher color display Free Disk Space: 12 Mb Minimum Memory: 16 Mb of RAM Recommended Memory: 32 Mb of RAM
INSTALLATION INSTRUCTION: 1. Place the CD-ROM into the CD-ROM drive. 2. Using My Computer or Windows Explorer, locate the “letter” that designates the CD-ROM drive. 3. Double-click on the CD-ROM drive icon and select the folder of choice NOTE:
This product requires that Microsoft Word 97 or higher be installed on your computer.
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LIMITED WARRANTY CRC Press LLC warrants the physical disk(s) enclosed herein to be free of defects in materials and workmanship for a period of thirty days from the date of purchase. If within the warranty period CRC Press LLC receives written notification of defects in materials or workmanship, and such notification is determined by CRC Press LLC to be correct, CRC Press LLC will replace the defective disk(s). The entire and exclusive liability and remedy for breach of this Limited Warranty shall be limited to replacement of defective disk(s) and shall not include or extend to any claim for or right to cover any other damages, including but not limited to, loss of profit, data, or use of the software, or special, incidental, or consequential damages or other similar claims, even if CRC Press LLC has been specifically advised of the possibility of such damages. In no event will the liability of CRC Press LLC for any damages to you or any other person ever exceed the lower suggested list price or actual price paid for the software, regardless of any form of the claim. CRC Press LLC specifically disclaims all other warranties, express or implied, including but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Specifically, CRC Press LLC makes no representation or warranty that the software is fit for any particular purpose and any implied warranty of merchantability is limited to the thirty-day duration of the Limited Warranty covering the physical disk(s) only (and not the software) and is otherwise expressly and specifically disclaimed. Since some states do not allow the exclusion of incidental or consequential damages, or the limitation on how long an implied warranty lasts, some of the above may not apply to you.
