ISO 9001:2000 in brief

1 What is Quality? 1 2 What is a Quality Management System? 5 2.1 What are the requirements of a Quality Management System? 9 2.2 What are Quality Control and Quality Assurance? 12 2.2.1 Quality Control 12 2.2.2 Quality Assurance 13 2.3 What are the costs and benefits of having a Quality Management System? 14 2.4 What is a Quality Manual? 17 2.4.1 What goes into a Quality Manual? 18 2.4.2 What does each part of the Quality Manual do? 19 2.5 What are Quality Policies and Objectives? 20 2.5.1 Mission statements 20 2.5.2 Corporate Policy Statement 22 2.5.3 Process-specific policies 22 2.5.4 How to set Quality Objectives 27 2.6 What is a Quality Process? 30 2.6.1 The Process Approach 31 2.6.2 Core Business Process 32 2.6.3 Supporting processes 33 2.6.4 Inter-relationship of process documentation 36 2.6.5 The hierarchy of processes 38 2.7 What is a Quality Procedure? 38 2.7.1 What is the best way to write a Quality Procedure 40 2.7.2 What should go into a Quality Procedure? 40 2.7.3 Annex A – Example Quality Procedure 43 2.8 What is a Work Instruction? 58 2.8.1 What should go into a Work Instruction? 58 2.8.2 How many Work Instructions can I have? 60 2.8.3 Annex B – Example Work Instruction 61 2.9 What is a Quality Plan? 77 2.9.1 What should be covered by a Quality Plan? 80 2.9.2 Other considerations 83 3 The history of Quality Standards 84 3.1 1979 88 3.2 1981 88 3.3 1987 89 3.4 1994 90 3.5 2000 91 4 Who produces Quality Standards? 92 5 What is ISO 9000:2000? 99 5.1 Background to the ISO 9001:2000 standard 99 5.2 The ISO 9000:2000 family of standards 105 5.2.1 ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary 107 5.2.2 ISO 9001:2000 Quality Management Systems – Requirements 108 5.3 The ‘consistent pair’ 110 5.4 Compatibility with other Management Systems 113 5.4.1 Compatibility with ISO 14001:1996 114 5.4.2 Compatibility with BS8800:2004 115 5.5 The Principles of ISO 9001:2000 115 5.5.1 Eight Principles of Management 115 5.5.2 The Process Model 117 5.6 Brief summary of ISO 9001:2000 requirements 119 5.6.1 Section 1 – Scope 119 5.6.2 Section 2 – Normative reference 119 5.6.3 Section 3 – Terms and definitions 119 5.6.4 Section 4 – Quality Management System 119 5.6.5 Section 5 – Management responsibility 120 5.6.6 Section 6 – Resource management 121 5.6.7 Section 7 – Product realisation 122 5.6.8 Section 8 – Measurement, analysis and improvement 123 5.7 ISO 9004:2000 Quality Management Systems – guidelines for performance improvement 124 6 How quality helps during a product’s life cycle 126 6.1 Design stage 127 6.2 Manufacturing stage 127 6.3 Acceptance stage 128 6.4 In-service stage 129 6.5 End of life stage 130 7 Who controls quality in an organisation? 131 7.1 Management 132 7.1.1 The 21 Management responsibilities 132 7.2 Quality management team 135 7.2.1 Quality Manager 136 7.2.2 Chief Quality Assurance Inspector 139 7.2.3 Section Quality Assurance Inspectors 140 7.2.4 Quality Assurance personnel 141 7.2.5 The staff 141 7.3 Quality Assurance resources 142 8 What are the purchaser’s responsibilities? 143 9 What are the supplier’s responsibilities? 145 10 What to do once the QMS is established 148 10.1 Continual improvement 148 10.2 Process metrics 150 10.3 Process improvement tools 151 10.3.1 How do I apply Six-Sigma to improve my processes? 153 10.3.2 Why have six Sigmas, when one would do? 153 10.4 Audit 154 10.5 Certification 157 11 Quality Management and computer technology 162 Annex A – ISO 9001:2000 – A summary of requirements 166 Abbreviations and acronyms 178 References 181 Glossary 184 Useful addresses 190