ISO 9001:2008 for Small Businesses

✍ Scribed by Ray Tricker

• Publisher: Taylor & Francis
• Year: 2011
• Tongue: English
• Leaves: 472
• Edition: 4th
• Category: Library

✦ Synopsis

Quality management is essential to small and medium-sized enterprises (SMEs) in order to  increase bottom-line results, save money and manage risks. Ray Tricker has already guided hundreds of businesses through the challenge and this new book, updated for the 2008 standard, provides: 

• Relevant examples that put the concepts and requirements into a real-life context 
• Down to earth explanations to help you determine what you need to change to achieve certification 
• Free, customisable, quality management system files, available from www.routledge.com/books/details/9781856178617 to give you a starting point from which to develop your own documentation

This established book, now in its fourth edition, provides step-by-step, prescriptive guidance, tailored to the non-quality specialist, on how to approach quality management and certification to ISO 9001 in a cost and time effective way. It enables small businesses to reap the benefits of ISO 9001 certification with minimum effort and paperwork, and without the need for expensive consultancy or training that takes employees out of the office.

✦ Table of Contents

Front Cover......Page 1
ISO 9001: 2008 for Small Businesses......Page 4
Copyright Page......Page 5
Contents......Page 6
Foreword......Page 11
Preface......Page 14
Books by the Same Author......Page 18
1.1 The Importance of Quality......Page 19
1.3 Quality Assurance......Page 22
1.4.1 The Significance of Specifications......Page 24
1.4.2 Types of Specification......Page 25
1.4.3 Supplier’s Responsibilities......Page 27
1.4.4 Purchaser’s Responsibilities......Page 28
1.5.1 Design Stage......Page 30
1.5.2 Manufacturing Stage......Page 33
1.5.4 In-Service Stage......Page 34
1.6 Benefits and Costs of Quality Assurance......Page 36
1.7 Costs of Quality Failure......Page 37
1.7.1 The Supplier......Page 38
1.7.2 The Purchaser......Page 39
2.1 What is ISO 9000?......Page 40
2.2 What National and International Standards are Available (and What is their Interoperability)?......Page 42
2.3 What about the Growth of Quality-specific Standards?......Page 46
2.4 Who is ISO?......Page 48
2.5.1 ISO 9000:1987......Page 49
2.5.3 ISO 9001:2000......Page 50
2.6 What are the Current ISO 9000 Standards?......Page 53
2.6.2 ISO 9001:2008 Quality Management Systems – Requirements......Page 54
2.7 Quality Management Principles......Page 55
2.8.1 The OHSAS 18000 Series......Page 59
2.8.2 ISO 14000......Page 60
2.9 What Other Standards are Based on ISO 9001:2000?......Page 61
2.9.5 Education......Page 62
2.9.10 Iron Ore Industry......Page 63
2.9.16 Telecommunications Industry......Page 64
2.10 What is ISO 9001:2008’s Basic Process?......Page 65
2.11 What is the Structure Of ISO 9001:2008?......Page 66
3. Terms and Definitions
......Page 67
4. Quality Management System
......Page 69
5. Management Responsibility
......Page 70
6. Resource Management
......Page 71
7. Product Realisation
......Page 72
8. Measurement, Analysis and Improvement
......Page 74
2.13.1 Purpose of an Audit......Page 81
2.13.3 Audit Categories......Page 82
2.13.4 ISO 19011:2002......Page 83
2.14.3 What Is Required for Certification?......Page 84
2.14.5 What Is the Difference Being Certifiedand Being Compliant?......Page 85
2.15 Who will be Responsible for Quality Within an Organisation?......Page 86
2.16 What is the Future Evolution Of ISO 9000......Page 87
3.1 Background......Page 88
3.2 But what is the Process Approach?......Page 90
3.3 Planning an Organisation’s Business Processes......Page 91
3.3.1 Core Business Process......Page 95
3.3.3 Primary Supporting Processes......Page 97
3.4 Inter-Relationship of Process Documentation......Page 99
4.1.1 Basic Requirements of a Quality Management System......Page 102
4.2 Quality Management System Principles......Page 105
4.3 Quality Management System Approach......Page 106
4.4 Quality Management System Structure......Page 108
4.4.1 QMS Documentation......Page 109
4.5 Quality Manual......Page 110
4.6 Processes......Page 111
4.7.1 What Documented Procedures Are Required by ISO 9001:2008?......Page 113
4.8.1 What Is the Difference Between a Work Instruction and a Record?......Page 114
4.9 Quality Plan......Page 115
4.9.2 Contract Review......Page 117
4.9.7 Product Identification and Traceability......Page 118
4.9.11 Non-Conforming Service/Product......Page 119
4.10 Quality Records......Page 120
5.1.1 Section 1.1 General......Page 123
5.2 Section 2 - Normative Reference......Page 124
5.3 Section 3 - Terms and Definitions......Page 125
5.4.1 Section 4.1 General Requirements......Page 126
5.4.2 Section 4.2 Documentation Requirements......Page 127
5.5 Section 5 - Management Responsibility......Page 133
5.5.1 Section 5.1 Management Commitment......Page 134
5.5.2 Section 5.2 Customer Focus......Page 135
5.5.3 Section 5.3 Quality Policy......Page 136
5.5.4 Section 5.4 Planning......Page 138
5.5.5 Section 5.5 Responsibility, Authority and Communication......Page 141
5.5.6 Section 5.6 Management Review......Page 143
5.6.1 Section 6.1 Provision of Resources......Page 147
5.6.2 Section 6.2 Human Resources......Page 149
5.6.3 Section 6.3 Infrastructure......Page 151
5.7 Section 7 - Product Realisation......Page 152
5.7.1 Section 7.1 Planning and Realisation......Page 153
5.7.2 Section 7.2 Customer-Related Processes......Page 155
5.7.3 Section 7.3 Design and Development......Page 158
5.7.4 Section 7.4 Purchasing......Page 171
5.7.5 Section 7.5 Production and Service Provision......Page 177
5.7.6 Section 7.6 Control of Measuring and Monitoring Equipment......Page 182
5.8 Section 8 - Measurement, Analysis and Improvement......Page 185
5.8.1 Section 8.1 General......Page 186
5.8.2 Section 8.2 Monitoring and Measurement......Page 187
5.8.3 Section 8.3 Control of Non-conforming Product......Page 193
5.8.4 Section 8.4 Analysis of Data......Page 195
5.8.5 Section 8.5 Improvement......Page 197
6. Example Quality Management System......Page 203
7. Self-assessment......Page 361
7.1 How ISO 9000 can be Used to Check Small Businesses Quality Management System......Page 362
7.2 Internal Audit......Page 363
7.2.1 Audit Plan......Page 364
7.2.2 Internal Audit Program......Page 365
7.3.1 Supplier Evaluation......Page 373
7.4.1 Multiple Evaluations and Audits......Page 377
7.4.4 Conformity Assessment......Page 378
7.5.3 Example Checklist of Typical Auditors Questions for ISO 9001:2008 Compliance......Page 379
Appendix 7A: Documentation Required by an Organisation to Meet ISO 9001:2008 Requirements......Page 380
Appendix 7B: ISO 9001:2008 Requirements of Management......Page 394
Appendix 7C: Example of Typical Auditors Questions for ISO 9001:2008 Compliance......Page 413
Appendix 7D: Example Internal Stage Audit Checks......Page 430
Annex A: Documentation Requirements......Page 435
Annex B: Customer Satisfaction......Page 440
Annex C: Guidance on Non-Conforming Products......Page 456
References......Page 460
Abbreviations and Acronyms......Page 462
Index......Page 465