ISO 9001:2000 Audit Procedures

✍ Scribed by Ray Tricker (MSc IEng FIET FCIM FIQA FIRSE)

• Publisher: Butterworth-Heinemann
• Year: 2005
• Tongue: English
• Leaves: 341
• Edition: 2
• Category: Library

✦ Synopsis

In order to meet the recommendations, requirements and specifications of ISO 9001:2000, organisations must undertake an audit of their own quality procedures and those of their suppliers. Likewise, when supplying ISO 9001:2000 accredited customers, suppliers must be prepared to undergo a similar audit. Revised, updated and expanded, ISO 9001:2000 Audit Procedures describes the methods for completing management reviews and quality audits, and outlines the experiences of working with 9001:2000 since its launch in 2000. It also includes essential new material on process models, generic pocesses, the requirements for mandatory documented procedures, and detailed coverage of auditors questionnaires. * Internal, external and third-party audits are central to ISO 9001:2000 accreditation * A new edition, updated in the light of three years experience with the standard and with essential information on the relationship of ISO 9001:2000 with other quality and environmental audit requirments and procedures * Includes audit check lists and templates; the only ISO 9001:2000 audit refence you will need

✦ Table of Contents

Cover......Page 1
ISO 9001:2000 Audit Procedures, Second edition......Page 4
Contents......Page 6
Foreword......Page 10
Preface......Page 12
Disadvantages of using an audit checklist......Page 14
About the author......Page 18
1.1 The revision process......Page 20
1.2 The main changes......Page 22
1.3.1 Requirements......Page 23
1.3.3 Consistent pair of standards......Page 24
1.3.4 Top management......Page 25
1.3.5 The process model......Page 26
1. Customer focused organisation......Page 27
2. Leadership......Page 29
3. Involvement of people......Page 30
4. Process approach......Page 31
5. System approach to management......Page 32
6. Continual improvement......Page 33
7. Factual approach to decision making......Page 35
1.5.2 People in the organisation......Page 38
1.5.5 Society......Page 39
1.7 Cost......Page 40
1.8.1 ISO 9000:2000......Page 42
1.8.2 ISO 9001:2000......Page 43
1. Management responsibility......Page 44
3. Product realisation......Page 46
4. Measurement, analysis and improvement......Page 47
1.8.2.3 Section 1 – Scope......Page 49
1.8.2.6 Section 4 – Quality Management System......Page 50
1.8.2.7 Section 5 – Management responsibility......Page 51
1.8.2.8 Section 6 – Resource management......Page 52
1.8.2.9 Section 7 – Product realisation......Page 53
1.8.2.10 Section 8 – Measurement, analysis and improvement......Page 54
1.8.2.11 Relationship between ISO 9001:2000 and ISO 14001......Page 55
1.8.3 ISO 9004:2000......Page 56
1.8.4 ISO 19011......Page 57
1.8.5 What other standards are based on ISO 9001:2000?......Page 58
Telecommunications industry......Page 59
Automotive industry......Page 60
Testing and calibration laboratories......Page 61
Petroleum, petrochemical and natural gas industries......Page 62
Computer softwar......Page 63
TickIT......Page 64
2 Background notes for auditors......Page 66
2.2 Types of audit......Page 69
2.3 Audit categories......Page 70
2.4 First party (internal) audit......Page 71
2.4.1 Internal audit programme......Page 73
2.5.1 The old audit process......Page 80
2.5.2 External audit programme......Page 82
On-site audit activities......Page 84
Multiple evaluations and audits......Page 87
2.6 Third party certification audits......Page 88
2.8 Conformity assessment......Page 91
2.9.1 Design stage......Page 93
2.9.2 Manufacturing stage......Page 95
2.9.3 Acceptance stage......Page 96
2.9.4 In-service stage......Page 97
2.9.5 Supplier’s responsibilities......Page 98
2.9.6 Purchaser’s responsibilities......Page 100
2.10.3 Training......Page 101
2.10.8 Quality Management System requirements......Page 102
2.11 Basic requirements of a Quality Management System......Page 103
2.11.1 Quality Management System principles......Page 105
2.11.3 Quality Management System reliability......Page 107
2.11.4 Quality Management System structure......Page 108
2.11.4.1 Quality Manual......Page 109
2.11.4.3 Quality procedures......Page 111
2.11.5 Quality Plan......Page 114
Document and data control......Page 116
Design control......Page 117
Inspection, measuring and test equipment......Page 118
Other considerations......Page 119
2.11.6 Quality records......Page 120
2.12.1 Management......Page 121
2.12.2.1 General functional description......Page 122
2.12.2.4 Co-ordination......Page 123
3 ISO 9001:2000 checklists......Page 124
Advantages of using an audit checklist......Page 125
Disadvantages of using an audit checklist......Page 126
3.1 ISO 9001:2000 – headings......Page 128
1.2 Application......Page 129
4.2.2 Quality Manual......Page 130
5.3 Quality policy......Page 131
5.5.2 Management representative......Page 132
6 Resource management......Page 133
6.4 Work environment......Page 134
7.2.3 Customer communication......Page 135
7.3.4 Design and development review......Page 136
7.4.1 Purchasing process......Page 137
7.5.2 Validation of processes for production and service provision......Page 138
8.1 General......Page 139
8.3 Control of non-conforming product......Page 140
8.5.2 Corrective action......Page 141
3.2 ISO 9001:2000 – explanation and likely documentation......Page 142
3.3 ISO 9001:2000 – organisational requirements......Page 151
3.4 ISO 9001:2000 – management responsibilities......Page 160
3.4.1 Top management responsibilities......Page 161
Systemic requirements......Page 165
Management requirements......Page 166
Resource requirements......Page 168
Realisation requirements......Page 169
Remedial requirements......Page 172
4.1 General requirements......Page 175
4.2.3 Control of documents......Page 176
5.3 Quality policy......Page 177
5.5.2 Management representative......Page 178
6.2.1 General......Page 179
7.1 Planning and product realisation......Page 180
7.2.3 Customer communication......Page 181
7.3.3 Design and development outputs......Page 182
7.3.7 Control of design and development changes......Page 183
7.4.3 Verification of purchased product......Page 184
7.5.3 Identification and traceability......Page 185
7.6 Control of monitoring and measuring devices......Page 186
8.2.2 Internal audit......Page 187
8.3 Control of a non-conforming product......Page 188
8.5.2 Corrective action......Page 189
3.6.1 Quality management system......Page 190
3.6.2 Documentation requirements......Page 191
3.6.3 Management commitment......Page 194
3.6.4 Customer focus......Page 195
3.6.6 Planning......Page 196
3.6.7 Responsibility, authority and communication......Page 197
3.6.8 Management review......Page 198
3.6.10 Human resources......Page 199
3.6.12 Work environment......Page 200
3.6.13 Planning and product realisation......Page 201
3.6.14 Customer-related processes......Page 203
3.6.15 Design and development......Page 204
3.6.16 Purchasing......Page 207
3.6.17 Production and service provision......Page 209
3.6.18 Control of monitoring and measuring devices......Page 214
3.6.19 Monitoring and measurement......Page 216
3.6.20 Control of non-conforming product......Page 220
3.6.21 Analysis of data......Page 221
3.6.22 Improvement......Page 222
3.7.1 Design stage......Page 223
3.7.2 Manufacturing stage......Page 226
3.7.3 Acceptance stage......Page 227
3.7.4 In-service stage......Page 228
3.8 Complete index for ISO 9001:2000......Page 230
3.9 ISO 9001:2000 crosscheck and correspondence form......Page 247
3.10.1 Systematic requirements......Page 251
3.10.2 Document requirements......Page 253
3.10.3 Management requirements......Page 255
3.10.4 Resource requirements......Page 260
3.10.5 Product requirements......Page 262
3.10.6 Measurement analysis and improvement requirements......Page 272
3.11 Comparison between ISO 9001:2000 and ISO 9001:1994......Page 278
3.12 Counter-comparison between ISO 9001:1994 and ISO 9001:2000......Page 280
3.13 A selection of audit forms......Page 282
3.14 ISO 9001:2000 elements covered and outstanding......Page 287
3.15 Abbreviations and acronyms common to quality management and auditing......Page 288
3.16 Glossary of terms used in quality......Page 303
Standards......Page 310
Other publications......Page 315
The ISO 9001 Auditing Practices Group......Page 317
Books by the same author......Page 319
Useful addresses......Page 322
Other useful addresses......Page 326
A......Page 332
C......Page 333
E......Page 334
I......Page 335
M......Page 337
P......Page 338
Q......Page 339
R......Page 340
Y......Page 341