ISO 9000 Quality Systems Handbook ISO 9000 Quality Systems Handbook Fourth Edition Completely revised in response to ISO 9000:2000 David Hoyle OXFORD AUCKLAND BOSTON JOHANNESBURG MELBOURNE NEW DELHI Butterworth-Heinemann Linacre House, Jordan Hill, Oxford OX2 8DP 225 Wildwood Avenue, Woburn, MA 01801-2041 A division of Reed Educational and Professional Publishing Ltd A member of the Reed Elsevier plc group First published 1994 Second edition 1994 Third edition 1998 Reprinted 1999 Fourth edition 2001 © David Hoyle 2001 All rights reserved. No part of this publication may be reproduced in any material form (including photocopying or storing in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright holder except in accordance with the provisions of the Copyright, Designs and Patents Act 1988 or under the terms of a licence issued by the Copyright Licensing Agency Ltd, 90 Tottenham Court Road, London, England W1P 0LP. Applications for the copyright holder’s written permission to reproduce any part of this publication should be addressed to the publishers British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloguing in Publication Data A catalogue record for this book is available from the Library of Congress ISBN 0 7506 4451 6 For information on all Butterworth-Heinemann publications visit our website at www.bh.com Composition by Genesis Typesetting, Laser Quay, Rochester, Kent Printed and bound in Great Britain Contents Preface ix Chapter 1 Introduction 1 Chapter 2 Basic concepts 18 Principles or prescription 18 Quality 19 The interested parties 22 The characteristics of quality 25 Achieving sustaining and improving quality 32 Summary 76 Basic concepts – Food for thought 77 Chapter 3 Role, origins and application of ISO 9000 80 The role of ISO 9000 80 Origin of ISO 9000 83 Changes to ISO 9000 91 Exclusions 102 An alternative structure 106 Certification to ISO 9001:2000 111 Summary 113 Role, origins and application – Food for thought 114 vi Contents Chapter 4 Quality management system 116 Summary of requirements 116 Establishing a quality management system 117 Identifying processes (4.1a) 121 Sequence and interaction of processes (4.1b) 127 Criteria and methods for effective operation and control (4.1c) 128 Documenting a quality management system (4.1, 4.2.1) 130 Documented procedures (4.2.1c) 137 Documents that ensure effective planning, operation and control of processes (4.2.1d) 140 Implementing a quality management system (4.1) 158 Managing processes (4.1) 159 Ensuring information availability (4.1d) 164 Ensuring the availability of resources (4.1d) 166 Measuring, monitoring and analysing processes (4.1e) 167 Maintaining a quality management system (4.1) 170 Continual improvement in the QMS and its processes (4.1 and 4.1f) 172 Preparing the quality manual (4.2.2) 174 Control of documents (4.2.3) 180 Control of records (4.2.1e and 4.2.4) 207 Summary 217 Quality Management System Questionnaire 218 Quality Management System – Food for Thought 219 Chapter 5 Management responsibility 222 Summary of requirements 222 Management commitment (5.1) 223 Customer focus (5.2) 236 Quality policy (5.3) 242 Quality objectives (5.4.1) 251 Quality management system planning (5.4.2) 261 Responsibility and authority (5.5.1) 267 Management Representative (5.5.2) 273 Internal communication (5.5.3) 280 Management Review (5.6) 284 Summary 297 Management Responsibility Questionnaire 297 Management Responsibility – Food for Thought 299 Chapter 6 Resource management 302 Summary of requirements 302 Determining resources (6.2.1) 304 Contents vii Providing resources (6.2.1) 307 Competence of personnel (6.2.1) 310 Training, awareness and competence (6.2.2) 314 Infrastructure (6.3) 329 Work environment (6.4) 336 Summary 349 Resource Management Questionnaire 350 Resource Management – Food for thought 351 Chapter 7 Product realization 353 Summary of requirements 353 Planning product realization processes (7.1) 356 Customer-related processes (7.2) 376 Design and development (7.3) 401 Purchasing (7.4) 449 Production and service provision (7.5) 473 Control of measuring and monitoring devices (7.6) 510 Summary 534 Product Realization Questionnaire 535 Product Realization – Food for Thought 540 Chapter 8 Measurement, analysis and improvement 542 Summary of requirements 542 Monitoring, measurement, analysis and improvement processes (8.1) 544 Customer satisfaction (8.2.1) 553 Internal audit (8.2.2) 556 Monitoring and measurement of processes (8.2.3) 572 Monitoring and measurement of product (8.2.4) 576 Control of nonconforming product (8.3) 584 Analysis of data (8.4) 595 Improvement (8.5) 609 Summary 640 Measurement, analysis and improvement questionnaire 641 Measurement, analysis and improvement – food for thought 644 Appendix A Glossary 647 Appendix B Related web sites 658 Index 661 Preface and acknowledgements Since the third edition of this handbook was published in 1998 there has been a radical change to the ISO 9000 family of standards. The standards have changed in structure from 20 elements to 8 sections; they have changed in intent from quality assurance to customer satisfaction; the terminology has changed so as to suit all types of organizations and there has been a change in direction from a focus on planning, inspection and test and the removal of nonconformity to a focus on objectives, processes, measurement, analysis and improvement. This meant that the handbook that had evolved over the previous eight years required a complete rewrite. However, I have maintained the basic purpose of the handbook – that of providing the reader with an understanding of each requirement of ISO 9001 through explanation, examples, lists, tables and diagrams. As there were over 300 requirements in the 1994 version of ISO 9001, this led to a book of considerable size – it was not intended as a quick read! It was and remains a source of reference and although I was tempted to restructure the book as an A-Z of ISO 9000 to reduce duplication, I have adhered to following the structure of the standard, adding clause numbers to the headings to make it user-friendly. The handbook is therefore laid out so as to follow the section numbers of ISO 9001. Most of the requirements of the 1994 version are included in the 2000 version of ISO 9001, but few remain exactly the same. Many have been reworded or condensed to remove over-prescriptive requirements and focus on general concepts. The differences between the 1994 and 2000 versions are shown in text x Preface and acknowledgements boxes by the side of the new requirement. In revising this handbook a lot of detail had to be omitted primarily as it was focused on manufacturing examples or detail requirements that are no longer included in the standard. Previous versions of this handbook therefore remain relevant and a useful source of information for those interested in seeking such detail. In the previous editions the approach taken was to identify a requirement and then explain its meaning followed by some examples to illustrate how it could be implemented. In this new edition I have followed a more structured approach and for each requirement answered three basic questions: What does it mean? Why is it important? How is it implemented? This is so that the requirements may be perceived as reflecting concepts valid outside the context of ISO 9000. At the end of each chapter there is a Questionnaire built from the requirements of the standard. It is not intended that these questions be used by auditors but by users of the standard in order to test the completeness of the system they have formalized. In place of the lists of do’s and don’ts and the task list of previous editions, I have included a section on Food for Thought. This is intended to cause the reader to reflect on the previous chapter, perhaps even change perceptions but mostly confirm understanding. The do’s and don’ts and task lists are within the text and will be consolidated in a new edition of the ISO 9000 Pocket Guide. Throughout the book a common approach has been taken to the require- ments of ISO 9000. This approach is a development of that what was used in the previous editions. The standard has become more generic, it now presents the requirements in a more user-friendly format and has adopted the process approach to management. While the requirements of ISO 9001 are expressed in a way that takes the reader through a cycle starting with the quality policy, leading onto quality objectives and ending with performance being reviewed against objectives, there remain many inconsistencies that could lead to confusion. Many of the linkages between policy, objectives, processes and results are inferred – they are not expressed unambiguously. It is only by studying ISO 9000, ISO 9001 and ISO 9004 and searching for understanding that a clear logic emerges. The use of the word quality creates an anomaly and tends to represent the standard as simply a tool to meet customer quality requirements and no others. This is not to say that the standard is flawed. It is only saying that the concepts could be presented more clearly. Consequently I have taken an approach that requires the principles and requirements contained in the ISO 9000 family to be perceived as general business concepts and not simply limited to the achievement of quality in its narrowest sense. While the arguments for taking this approach are addressed in the book, the theme of the book is reflected in the following principles. The quality policy exists to shape behaviour and establish the core values in an organization and therefore equates with the corporate policy – no benefits are gained from specifically expressing a quality policy and ignoring other [...]... razzmatazz, that the part that was formalized using ISO 9000 became labelled as the ISO 9000 quality system It isolated parts of the organization and made them less efficient Other organizations recognized that quality was an 4 ISO 9000 Quality Systems Handbook Figure 1.1 Bolt-on systems important issue and formalized part of their informal management system When ISO 14001 came along this resulted in the formalization... this handbook on ISO 9000: 2000 it may be useful to take a look at these perceptions – look at how we have come to think about ISO 9000, quality, quality systems, certification and inspection A realization of these perceptions will hopefully enable us to approach the new standard with a different perspective or at least provide food for thought How we think about ISO 9000 To the advocate, ISO 9000 is... on the quality of anything we need a measure of its characteristics and a basis for comparison By combining the definition of the terms quality 22 ISO 9000 Quality Systems Handbook and requirement in ISO 9000: 2000, quality can be expressed as the degree to which a set of inherent characteristics fulfils a need or expectation that is stated, generally implied or obligatory Having made the comparison we... was not the intent of ISO 9000 then clearly we have to do something about it But why should these perceptions be changed? After all, can 340,000 organizations have got it wrong? Some organizations in fact did use ISO 9000 wisely but they are likely to be in the minority Many organizations also chose not to pursue ISO 9000 certification and focused on 2 ISO 9000 Quality Systems Handbook TQM but that... on quality Auditors often held the view that if an organization took the trouble to document it, it must be essential to product quality and therefore by not doing it, product quality must be affected! How ISO 9000 made us think about quality ISO 9000 was conceived to bring about an improvement in product quality It was believed that if organizations were able to demonstrate they were operating a quality. .. to be a standard Therefore by this definition, ISO 9000 is a standard ISO 9000 is also perceived as a label given to the family of standards and the associated certification scheme However, certification was never a requirement of any of the standards in the ISO 9000 family – this came from customers Such notions as ‘We are going for ISO 9000 imply ISO 9000 is a goal like a university degree and like... belief that ISO 9000 was simply a matter of documenting what you do and doing what you document This led to the perception that ISO 9000 built a bureaucracy of procedures, records and forms with very little effect on quality The 1994 version also created a perception that quality systems only exist to assure customers that product meets requirements ISO 9001 was often referred Figure 1.2 Separate systems. .. related to the achievement of quality Those producing the 12 ISO 9000 Quality Systems Handbook documentation were focusing on meeting the standard not on achieving quality Those producing the product were focusing on meeting the customer requirement but the two were often out of sync As quality assurance became synonymous with procedures, so people perceived that they could achieve quality by following procedures... Ishikawa, Crosby and many others ISO 9000: 2000 is unlikely to change this situation because all these problems are caused by people who for one reason or another chose not to do the right things All we can hope for is that ISO 9000: 2000 will raise the bar enough to enable more organizations to satisfy more customers and do less harm to society 16 ISO 9000 Quality Systems Handbook Introduction – Food for... not quality Before ISO 9000, organizations were faced with meeting all manner of rules and regulations Government inspectors and financial auditors frequently examined the books and practices for evidence of wrong-doing but none of this 8 ISO 9000 Quality Systems Handbook resulted in organizations creating something that was not integrated within the routines they applied to manage the business When ISO . ISO 9000 Quality Systems Handbook ISO 9000 Quality Systems Handbook Fourth Edition Completely revised in response to ISO 9000: 2000 David Hoyle OXFORD AUCKLAND. using ISO 9000 became labelled as the ISO 9000 quality system. It isolated parts of the organization and made them less efficient. Other organizations recognized that quality was an 4 ISO 9000 Quality. fact did use ISO 9000 wisely but they are likely to be in the minority. Many organizations also chose not to pursue ISO 9000 certification and focused on 2 ISO 9000 Quality Systems Handbook TQM