Contents
Preface ix
Acknowledgements xiii
Chapter 1 Basic concepts 1
Introduction 1
Principles or prescription 3
Quality 4
The interested parties 8
The characteristics of quality 11
Achieving sustaining and improving quality 18
Managing processes 54
Developing an effective system 65
Summary 74
Basic concepts – Food for thought 75
Chapter 2 Perceptions of ISO 9000 and its derivatives 76
Introduction 76
How we think about ISO 9000 77
How we think about quality management system 78
How we think about certification 82
How ISO 9000 made us think about quality 87
How we think about reviews, inspections and audits 90
Is ISO/TS 16949:2002 any different? 91
Summary 92
Perceptions of ISO 9000 and its derivatives –
Food for thought 94
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Chapter 3 Role, origins and application of ISO/TS 16949 95
The role of ISO/TS 16949 95
The origins 97
Emergence of a common certification scheme 105
Applications of ISO/TS 16949 requirements 110
Summary 113
Role, origins and application – Food for thought 114
Chapter 4 Quality management system 115
Summary of requirements 115
Establishing a quality management system 116
Identifying processes 118
Sequence and interaction of processes 125
Criteria and methods for effective operation and control 126
Documenting a quality management system 128
Documented procedures 132
Documents that ensure effective planning, operation and
control of processes 135
What should be documented? 143
Implementing a quality management system 147
Managing processes 148
Ensuring information availability 149
Ensuring the availability of resources 150
Measuring, monitoring and analyzing processes 151
Maintaining a quality management system 155
Continual improvement in the quality management
system and its processes 156
Outsourcing 158
Preparing the quality manual 159
Control of documents 164
Control of records 191
Summary 201
Quality management system requirements checklist 202
Quality management system – Food for thought 204
Chapter 5 Management responsibility 205
Summary of requirements 205
Management commitment 206
Customer focus 220
Quality policy 225
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Quality objectives 234
Quality management system planning 244
Responsibility and authority 249
Management representative 258
Internal communication 265
Management review 269
Summary 282
Management responsibility requirement checklist 283
Management responsibility – Food for thought 285
Chapter 6 Resource management 286
Summary of requirements 286
Determining resources 288
Providing resources 291
Competence of personnel 294
Training awareness and competence 298
Infrastructure 318
Work environment 327
Summary 339
Resource management requirements checklist 341
Resource management – Food for thought 343
Chapter 7 Product realization 345
Summary of requirements 345
Planning product realization processes 347
Customer-related processes 369
Design and development 395
Purchasing 450
Production and service provision 478
Control of monitoring and measuring devices 518
Summary 544
Product realization requirements checklist 545
Product realization – Food for thought 552
Chapter 8 Measurement, analysis and improvement 553
Summary of requirements 553
Monitoring, measurement, analysis and
improvement processes 556
Customer satisfaction 566
Contents vii
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viii Contents
Internal audit 570
Monitoring and measurement of processes 590
Monitoring and measurement of product 596
Control of nonconforming product 605
Analysis of data 616
Improvement 629
Summary 668
Measurement, analysis and improvement
requirements checklist 670
Measurement, analysis and improvement – Food for thought 674
Appendix A – Glossary 675
Appendix B – Related web sites 689
Bibliography 691
Index 695
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Preface
The first edition of this handbook was published in response to ISO/TS 16949:1999
just prior to the total revision of the ISO 9000 family of standards. Three years later
ISO/TS 16949 was revised to take account of the changes in ISO 9000. As ISO/TS
16949 embodies the complete text of ISO 9001, this second edition of the Automotive
Quality Systems Handbook is based on the fourth edition of the ISO 9000 Quality
System Handbook which was produced to align with ISO 9001:2000. The three pre-
vious editions addressed ISO 9000:1987 and 1994.
Approach to the requirements
Although the handbook required a complete rewrite, I have maintained its basic pur-
pose, i.e. that of providing the reader with an understanding of each requirement of
ISO/TS 16949 through explanation, examples, lists, tables and diagrams. As there are
over 400 requirements in ISO/TS 16949, this has led to a book of considerable size;
it was not intended as a quick read! It was and remains a source of reference. I have
adhered to following the structure of the standard, adding clause numbers to the head-
ings to make it user-friendly. The handbook is therefore laid out so as to follow the sec-
tion numbers of ISO/TS 16949:2002.
In the previous edition the approach taken was to identify a requirement and then
explain its meaning followed by some examples to illustrate how it could be imple-
mented. 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 impor-
tant? How is it implemented? This is so that the requirements may be perceived as
reflecting concepts valid outside the context of ISO/TS 16949.
I make no apologies for the layout. I have chosen to address the requirements of the
standard in the sequence they are presented in the standard itself. Although it is claimed
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