1.5.11 What is the ISO 9000 family? 37
1.5.12 Integrated Management Systems 41
1.5.13 ISO 9000:2000 42
1.5.14 ISO 9001:2000 43
1.5.15 Process approach 49
1.5.16 Planning an organisation’s business processes 51
1.5.17 Brief summary of the ISO 9001:2000 standard 60
1.5.18 ISO 9004:2000 Quality Management Systems –
guidelines for performance improvement 66
1.6 Certification 67
1.6.1 Who can certify an organisation? 67
1.6.2 What is required for certification? 68
1.6.3 Who will be responsible for quality within
an organisation? 68
1.7 Assistance (in the UK) for obtaining a Quality
Management System 69
1.7.1 Government assistance 69
1.7.2 Assistance for the smaller company 70
1.7.3 Assistance in setting up a Quality Management
System in America 71
Appendix A ISO 14001 – Environmental Management System 73
Part Two – The Structure of ISO 9001:2000 79
2 The structure of ISO 9001:2000 81
2.1 Section 1 – Scope 81
2.1.1 Section 1.1 General 81
2.1.2 Section 1.2 Application 81
2.2 Section 2 – Normative reference 82
2.3 Section 3 – Terms and definitions 82
2.4 Section 4 – Quality Management System 83
2.4.1 Section 4.1 General requirements 84
2.4.2 Section 4.2 Documentation requirements 85
2.5 Section 5 – Management responsibility 89
2.5.1 Section 5.1 Management commitment 91
2.5.2 Section 5.2 Customer focus 92
2.5.3 Section 5.3 Quality policy 93
2.5.4 Section 5.4 Planning 95
2.5.5 Section 5.5 Responsibility, authority and communication 97
2.5.6 Section 5.6 Management review 99
2.6 Section 6 – Resource management 103
2.6.1 Section 6.1 Provision of resources 104
2.6.2 Section 6.2 Human resources 105
2.6.3 Section 6.3 Infrastructure 107
2.6.4 Section 6.4 Work environment 107
2.7 Section 7 – Product realisation 108
2.7.1 Section 7.1 Planning and realisation 109
2.7.2 Section 7.2 Customer-related processes 111
2.7.3 Section 7.3 Design and development 114
2.7.4 Section 7.4 Purchasing 126
2.7.5 Section 7.5 Production and service provision 131
2.7.6 Section 7.6 Control of measuring and monitoring
devices 136
2.8 Section 8 – Measurement, analysis and improvement 139
2.8.1 Section 8.1 General 140
2.8.2 Section 8.2 Monitoring and measurement 140
2.8.3 Section 8.3 Control of non-conforming product 147
2.8.4 Section 8.4 Analysis of data 149
2.8.5 Section 8.5 Improvement 150
Part Three – The Importance of Quality Control and Quality Assurance 157
3 Quality control and quality assurance 159
3.1 Quality control 159
3.2 Quality assurance 160
3.3 Specifications 161
3.3.1 The significance of specifications 161
3.3.2 Types of specification 162
3.3.3 Manufacturer’s responsibilities 163
3.3.4 Purchaser’s responsibilities 165
3.4 Quality assurance during a product’s life cycle 166
3.4.1 Design stage 166
3.4.2 Manufacturing stage 169
3.4.3 Acceptance stage 170
3.4.4 In-service stage 171
3.5 Benefits and costs of quality assurance 173
3.6 Costs of quality failure 174
3.6.1 The manufacturer 174
3.6.2 The purchaser 175
Part Four – Quality Management System 177
4 Quality Management System 179
4.1 Quality Management System – requirements 179
4.1.1 Basic requirements of a Quality Management System 180
4.2 Quality Management System principles 181
4.3 Quality Management System approach 183
4.3.1 What is a quality system? 185
4.3.2 What is the difference between a quality manual
and a quality system? 185
4.4 Quality Management System structure 185
4.4.1 QMS documentation 186
4.5 Quality Manual 187
4.6 Processes 188
4.7 Quality Procedures 190
4.7.1 What documented procedures are required
by ISO 9001:2000? 190
4.8 Work Instructions 191
4.8.1 What is the difference between a Work Instruction
and a record? 192
4.9 Quality Plan 192
4.9.1 Management responsibility 194
4.9.2 Contract review 195
4.9.3 Design control 195
4.9.4 Document and data control 196
4.9.5 Purchasing 196
4.9.6 Customer supplied product 196
4.9.7 Product identification and traceability 196
4.9.8 Process control 196
4.9.9 Inspection and testing 197
4.9.10 Inspection, measuring and test equipment 197
4.9.11 Non-conforming service/product 197
4.9.12 Other considerations 198
4.10 Quality records 198
Part Five – Quality Organisational Structure 201
5 Quality organisational structure 203
5.1 Management 204
5.2 Quality assurance personnel 206
5.2.1 Quality manager 207
5.2.2 Chief Quality Assurance Inspector 209
5.2.3 Section Quality Assurance Inspectors 210
5.2.4 Quality assurance personnel 211
5.2.5 Quality assurance resources 212
Part Six – Example Quality Management System 213
Part Seven – Self-assessment 369
7 Self-assessment 371
7.1 How ISO 9000 can be used to check an organisation’s
Quality Management System 371
7.2 Internal audit 372
7.2.1 Audit plan 373
7.2.2 Internal audit program 374
7.3 External audit 382
7.3.1 Supplier evaluation 382
7.4 The surveillance or quality audit visit 386
7.4.1 Multiple evaluations and audits 387
7.4.2 Secondary audit 387
7.4.3 Third-party evaluation 387
7.4.4 Conformity assessment 387
7.5 ISO 9001:2000 checklist 388
7.5.1 ISO 9001:2000 headings 388
7.5.2 ISO 9001:2000 explanations and likely documentation 388
7.5.3 ISO 9001:2000 requirements of management 388
7.5.4 Example of an external auditor’s checklist 389
7.5.5 Example stage audit checklist 389
7.5.6 Index for ISO 9001:2000 389
Appendix 7A ISO 9001:2000 headings 390
Appendix 7B ISO 9001:2000 – Explanations and
likely documentation 392
Appendix 7C Requirements of management 403
Appendix 7D Example checklists for auditors 415
Appendix 7E Example internal stage audit checks 429
Appendix 7F Index for ISO 9001:2000 436
Annex A Documentation requirements 453
Annex B Customer satisfaction 459
Annex C Guidance on non-conforming products 477
References 483
Abbreviations and acronyms 491
Glossary of terms 493
Useful addresses 503
Index 507
Дата введения 13 ноября 2009 г.
Докладчик: Назарова Ирина Георгиевна –
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