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ISO 9001
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Table of Contents

Foreword xi
Preface xiii
1 Background to the ISO 9001:2000 standard 1
1.1 The revision process 1
1.2 The main changes 3
1.3 Key changes 4
1.3.1 Requirements 4
1.3.2 Revised title 5
1.3.3 Consistent pair of standards 5
1.3.4 Top management 6
1.3.5 The process model 7
1.4 Benefits of the revised standards 19
1.5 Other benefits 19
1.5.1 Customers 19
1.5.2 People in the organisation 19
1.5.3 Owners and investors 20
1.5.4 Suppliers and partners 20
1.5.5 Society 20
1.6 Permissible exclusions 21
1.7 Cost 21
1.8 The ISO 9000:2000 family of standards 23
1.8.1 ISO 9000:2000 23
1.8.2 ISO 9001:2000 24
1.8.3 ISO 9004:2000 37
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viii Contents
1.8.4 ISO 19011 38
1.8.5 What other standards are based on ISO 9001:2000 39
2 Background notes for auditors 47
2.1 Purpose of an audit 50
2.2 Types of audit 50
2.3 Audit categories 51
2.4 First party (internal) audit 52
2.4.1 Internal audit programme 54
2.5 External audit 61
2.5.1 The old audit process 61
2.5.2 External audit programme 63
2.5.3 Ongoing supplier surveillance visits 68
2.6 Third party certification audits 69
2.7 What is the cost of certification? 72
2.8 Conformity assessment 72
2.9 Quality assurance during a product's or service's lifecycle 74
2.9.1 Design stage 74
2.9.2 Manufacturing stage 76
2.9.3 Acceptance stage 77
2.9.4 In-service stage 78
2.9.5 Supplier's responsibilities 79
2.9.6 Purchaser's responsibilities 81
2.10 The effect of ISO 9001:2000's new requirements 82
2.10.1 Customer focus 82
2.10.2 Customer communication 82
2.10.3 Training 82
2.10.4 Legal and regulatory compliance 83
2.10.5 QMS development and improvement 83
2.10.6 Product conformity 83
2.10.7 Measurement and continual improvement 83
2.10.8 Quality Management System requirements 83
2.11 Basic requirements of a Quality Management System 84
2.11.1 Quality Management System principles 86
2.11.2 Quality Management System approach 88
2.11.3 Quality Management System reliability 88
2.11.4 Quality Management System structure 89
2.11.5 Quality Plan 95
2.11.6 Quality records 101
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Contents ix
2.12 Quality organisational structure 102
2.12.1 Management 102
2.12.2 The Quality Manager 103
3 ISO 9001:2000 checklists 105
Advantages of using an audit checklist 106
Disadvantages of using an audit checklist 107
3.1 ISO 9001:2000 - headings 109
3.2 ISO 9001:2000 - explanation and likely documentation 123
3.3 ISO 9001:2000 - organisational requirements 132
3.4 ISO 9001:2000 - management responsibilities 141
3.4.1 Top management responsibilities 142
3.4.2 General management requirements 146
3.5 ISO 9001:2000 - audit checks 156
3.5.1 Section 4 - Quality Management System 156
3.5.2 Section 5 - Management responsibility 158
3.5.3 Section 6 - Resource management 160
3.5.4 Section 7 - Product realisation 161
3.5.5 8 Measurement, analysis and improvement 168
3.6 Additional (general purpose) check sheets 171
3.6.1 Quality management system 171
3.6.2 Documentation requirements 172
3.6.3 Management commitment 175
3.6.4 Customer focus 176
3.6.5 Quality policy 177
3.6.6 Planning 177
3.6.7 Responsibility, authority and communication 178
3.6.8 Management review 179
3.6.9 Provision of resources 180
3.6.10 Human resources 180
3.6.11 Infrastructure 181
3.6.12 Work environment 181
3.6.13 Planning and product realisation 182
3.6.14 Customer-related processes 184
3.6.15 Design and development 185
3.6.16 Purchasing 188
3.6.17 Production and service provision 190
3.6.18 Control of monitoring and measuring devices 195
3.6.19 Monitoring and measurement 197
3.6.20 Control of non-conforming product 201
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3.6.21 Analysis of data 202
3.6.22 Improvement 203
3.7 Example stage audit checks 204
3.7.1 Design stage 204
3.7.2 Manufacturing stage 207
3.7.3 Acceptance stage 208
3.7.4 In-service stage 209
3.8 Complete index for ISO 9001:2000 211
3.9 ISO 9001:2000 crosscheck and correspondence form 228
3.10 Audit check sheet 232
3.11 Audit check sheet 232
3.11.1 Systematic requirements 232
3.11.2 Document requirements 234
3.11.3 Management requirements 236
3.11.4 Resource requirements 241
3.11.5 Product requirements 243
3.11.6 Measurement analysis and improvement 253
requirements
3.11 Comparison between ISO 9001:2000 and ISO 9001:1994 259
3.12 Counter-comparison between ISO 9001:1994 261
and ISO 9001:2000
3.13 A selection of audit forms 263
3.14 ISO 9001:2000 elements covered and outstanding 268
3.15 Abbreviations and acronyms common to quality 269
management and auditing
3.16 Glossary of terms used in quality 284
References 291
Useful addresses 303
Index 313

About the Author

Ray Tricker is the Principal Consultant of Herne European Consultancy Ltd - a company specialising in ISO 9000 Management Systems - and is also an established author. He served with the Royal Corps of Signals (for a total of 37 years) during which time he held various managerial posts culminating in being appointed as the Chief Engineer of NATO's Communication Security Agency (ACE COMSEC). Most of Ray's work since joining Herne has centred on the European Railways. He has held a number of posts with the Union International des Chemins de fer (UIC) (e.g. Quality Manager of the European Train Control System (ETCS)) and with the European Union (EU) Commission (e.g. T500 Review Team Leader, European Rail Traffic Management System (ERTMS) Users Group Project Co-ordinator, HEROE Project Co-ordinator) and currently (as well as writing books!) he is busy assisting small businesses from around the world produce their own auditable Quality and/or Integrated Management Systems to meet the requirements of ISO 9001:2008, ISO 14001 and OHSAS standards. He is also a UKAS Assessor for the assessment of certification bodies for the harmonisation of the trans-European high speed railway network.

Reviews

'This book fills a need for a guide which will assist auditors in completing internal, external and third party audits of existing QMSs, newly implemented QMSs and transitional QMSs ... The book usefully describes methods for completing management reviews and quality audits.'
Quality World, April 2002

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