ISO 9001 :2000 for small businesses

Part One – The Background to ISO 9000 1 1 ISO 9000 3 1.1 ISO 9000 3 1.2 Interoperability of standards 6 1.3 The demand for standardisation of Quality Management Systems 9 1.4 The background to the ISO 9000 set of quality standards 10 1.4.1 What does the term ISO mean? 11 1.4.2 ISO 9000:1987 12 1.4.3 ISO 9000:1994 13 1.5 ISO 9001:2000 14 1.5.1 Background to the ISO 9001:2000 standard 14 1.5.2 The revision process 16 1.5.3 Factors considered during the revisions of the standards 17 1.5.4 Key changes in the standards 19 1.5.5 What are the aims, benefits, main changes and new requirements of ISO 9001:2000? 21 1.5.6 Certification registration and accreditation 24 1.5.7 The ‘consistent pair’ 26 1.5.8 Quality management principles 26 1.5.9 What has happened to other standards previously based on ISO 9000:1994? 29 1.5.10 Are there any other standards based on ISO 9001:2000? 36 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 vi Contents Contents vii 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 viii Contents 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 Contents ix 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