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E-raamat: Quality and Standards in Electronics

Ray Tricker (Principal Consultant and Managing Director of Herne European Consultancy Ltd, UK)

Formaat: PDF+DRM
Ilmumisaeg: 02-Dec-2012
Kirjastus: Newnes (an imprint of Butterworth-Heinemann Ltd )
Keel: eng
ISBN-13: 9780080938431

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Formaat: PDF+DRM
Ilmumisaeg: 02-Dec-2012
Kirjastus: Newnes (an imprint of Butterworth-Heinemann Ltd )
Keel: eng
ISBN-13: 9780080938431

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A reference manual to the various standards and organizations involved in the quality assurance of electronic devices and components. Also helps small companies set up their own quality management system by explaining the implications and requirements of a quality system, presenting case studies, and recommending audit procedures. Focuses on the most common international standard, ISO 9000, and how it can be used to check a company's quality system. Annotation c. by Book News, Inc., Portland, Or.

A manufacturer or supplier of electronic equipment or components needs to know the precise requirements for component certification and quality conformance to meet the demands of the customer. This book ensures that the professional is aware of all the UK, European and International necessities, knows the current status of these regulations and standards, and where to obtain them.

A manufacturer or supplier of electronic equipment or components needs to know the precise requirements for component certification and quality conformance to meet the demands of the customer. This book ensures that the professional is aware of all the UK, European and International necessities, knows the current status of these regulations and standards, and where to obtain them.

Arvustused

"Engineers and managers in large as well as small organizations will find this an essential guide to information never previously compiled in one book." --Booknews on the Internet

Foreword

(4)

Preface

xix

(1)

Acknowledgements

Part 1 The Importance of Quality Control and Quality Assurance

(15)

1.1 Quality control

(2)

1.2 Quality assurance

(2)

1.3 Specifications

(4)

1.3.1 The significance of specifications

(1)

1.3.2 Types of specification

(2)

1.3.2.1 General specification

(1)

1.3.2.2 Overall performance specification

(1)

1.3.2.3 Standard specification

(1)

1.3.3 Manufacturer's responsibilities

(1)

1.3.4 Purchaser's responsibilities

(1)

1.4 Quality assurance during a product's life cycle

(5)

1.4.1 Design stage

(2)

1.4.2 Manufacturing stage

(1)

1.4.3 Acceptance stage

(1)

1.4.4 In-service stage

(2)

1.5 Benefits and costs of quality assurance

(1)

1.6 Costs of quality failure

(1)

1.6.1 The manufacturer

(1)

1.6.2 The purchaser

(1)

1.7 Recommended further reading

(1)

Part 2 Quality System

(22)

2.1 Basic requirements of a quality system

(2)

2.2 Quality-system principles

(3)

2.3 Quality-system reliability

(1)

2.4 Quality manual

(1)

2.5 Quality plan

(1)

2.6 ISO 10005

(4)

2.6.1 Management responsibility

(1)

2.6.2 Contract review

(1)

2.6.3 Design control

(1)

2.6.4 Document and data control

(1)

2.6.5 Purchasing

(1)

2.6.6 Customer-supplied product

(1)

2.6.7 Product identification and traceability

(1)

2.6.8 Process control

(1)

2.6.9 Inspection and testing

(1)

2.6.10 Inspection, measuring and test equipment

(1)

2.6.11 Non-conforming service/product

(1)

2.6.12 Other considerations

(1)

2.7 Quality records

(1)

Appendix 2A: Quality organizational structure -- management

(2)

Appendix 2B: Quality organizational structure -- quality assurance personnel

(7)

2B.1 Quality manager

(2)

2B.1.1 General functional description

(1)

2B.1.2 Tasks

(1)

2B.1.3 Responsibilities

(1)

2B.1.4 Co-ordination

(1)

2B.2 Chief quality-assurance inspector

(2)

2B.3 Section quality-assurance inspectors

(1)

2B.4 Quality-assurance personnel

(1)

2B.5 Quality-assurance resources

(1)

Part 3 ISO 9000

(51)

3.1 Interoperability of standards

(2)

3.2 The demand for standardization in support of quality systems

(1)

3.3 The background to the ISO 9000 set of quality standards

(1)

3.4 Future revisions of ISO 9000

(1)

3.5 ISO 9000

(1)

3.6 The ISO 9000 series

(2)

3.6.1 ISO 9000/1

(1)

3.6.2 ISO 9000/2

(1)

3.6.3 ISO 9000/3

(1)

3.6.4 ISO 9000/4

(1)

3.6.5 ISO 9000, 9002 and 9003

(1)

3.7 ISO 9004

(1)

3.7.1 ISO 9004/1

(1)

3.7.2 ISO 9004/2

(1)

3.7.3 ISO 9004/3

(1)

3.7.4 ISO 9004/4

(1)

3.8 Choosing the relavant part of ISO 9000

(5)

3.8.1 ISO 9001

(1)

3.8.2 ISO 9002

(3)

3.8.3 ISO 9003

(1)

3.9 Assistance in obtaining a quality system

(1)

3.9.1 Government assistance

(1)

3.9.1.1 DTI business links

(1)

3.9.1.2 National Quality Information Centre

(1)

3.9.2 Assistance for the small company

(1)

3.10 Recommended further reading

(3)

Appendix 3A: Checklist for ISO 9000

(6)

Appendix 3B: The elements of ISO 9000

(27)

3B.1 Management responsibility (ISO 9001: Section 4.1)

(1)

3B.2 Quality system (ISO 9001: Section 4.2)

(2)

3B.2.1 Procedures

(1)

3B.2.2 The procedures manual

(1)

3B.2.3 Working instructions

(1)

3B.3 Contract review (ISO 9001: Section 4.3)

(1)

3B.3.1 The contract document

(1)

3B.3.2 Contract review

(1)

3B.4 Design control (ISO 9001: Section 4.4)

(4)

3B.4.1 Design input

(1)

3B.4.2 Process control and instructions

(1)

3B.4.3 Marketing implications

(1)

3B.4.4 Components, parts and materials

(1)

3B.4.5 Specifications and tolerances

(1)

3B.4.6 Health and safety

(1)

3B.4.7 Computers

(1)

3B.4.8 Design output

(1)

3B.4.9 Design review

(1)

3B.4.10 Design process review

(1)

3B.4.11 Design verification and review

(1)

3B.5 Document and data control (ISO 9001: Section 4.5)

(1)

3B.6 Purchasing (ISO 9001: Section 4.6)

(1)

3B.6.1 Control of a product or service obtained from a third party

(1)

3B.7 Customer-supplied product (ISO 9001: Section 4.7)

(1)

3B.8 Product identification and traceability (ISO 9001: Section 4.8)

(1)

3B.9 Process control (ISO 9001: Section 4.9)

(1)

3B.10 Inspection and testing (ISO 9001: Section 4.10)

(2)

3B.10.1 Goods inwards

(1)

3B.10.2 Inspection and testing

(1)

3B.10.3 Inspection procedures

(1)

3B.11 Inspection, measuring and test equipment (ISO 9001: Section 4.11)

(1)

3B.11.1 Control of inspection, measuring and testing equipment

(1)

3B.11.2 Maintenance

(1)

3B.11.3 Calibration

(1)

3B.12 Inspection and test status (ISO 9001: Section 4.12)

(1)

3B.12.1 Production control

(1)

3B.12.2 Product testing

(1)

3B.12.3 Special processes

(1)

3B.21 Control of non-conforming product (ISO 9001: Section 4.13)

(4)

3B.13.1 Material control and traceability

(1)

3B.13.2 Control of non-conformity

(4)

3B.14 Corrective action (ISO 9001: Section 4.14)

(3)

3B.14.1 Concessions and approvals

(1)

3B.14.2 Concession scheme

(1)

3B.14.3 Defects and defect reports

(1)

3B.14.4 Bonded store

(1)

3B.15 Handling, storage, packaging and delivery (ISO 9001: Section 4.15)

(2)

3B.15.1 Storage

(1)

3B.15.2 Delivery

(1)

3B.16 Quality records (ISO 9001: Section 4.16)

(1)

3B.16.1 Documentation

(1)

3B.16.2 Logistic support

(1)

3B.17 Internal quality audits (ISO 9001: Section 4.17)

(1)

3B.17.1 Audit plan

(1)

3B.18 Training (ISO 9001: Section 4.18)

(1)

3B.19 Servicing (ISO 9001: Section 4.19)

(1)

3B.20 Statistical techniques (ISO 9001: Section 4.20)

(1)

3B.20.1 Records

(1)

3B.21 Recommended further reading

(1)

Part 4 How ISO 9000 Can be used to Check a Company's Quality System

(15)

4.1 Internal audit

(1)

4.1.1 Purpose

(1)

4.2 Responsibility

(1)

4.2.1 Method

(1)

4.2.2 Results and achievements

(1)

4.3 External audit

(3)

4.3.1 Supplier evaluation

(1)

4.3.2 Evaluation team

(1)

4.3.3 Pre-evaluation meeting

(1)

4.3.4 Study of the quality manual

(1)

4.3.5 The evaluation

(1)

4.3.5.1 Acceptable system control

(1)

4.3.5.2 Weak system control

(1)

4.3.5.3 Unacceptable system control

(1)

4.3.5.4 DTI manufacturers lists

(1)

4.4 The surveillance or quality audit visit

(2)

4.4.1 Multiple evaluations and audits

(1)

4.4.1.1 Secondary audit

(1)

4.4.1.2 Third-party evaluation

(1)

4.5 Assessment of quality-management systems

(3)

4.5.1 Pre-assessment

(1)

4.5.2 The assessment

(1)

4.5.3 Reporting

(1)

4.5.4 Approval

(1)

4.5.5 Maintenance of approval

(1)

4.5.6 Triennial reassessment

(1)

4.5.7 System changes

(1)

4.5.8 Confidentiality

(1)

4.5.9 Suspension or withdrawal of approval

(1)

4.5.10 Complaints and appeals

(1)

4.5.11 Appeals

100

(1)

4.6 Recommended further reading

100

(1)

Appendix 4A: ISO 9000 auditor's checklist

100

(4)

Part 5 Statistical Methods Applied to Quality Control

104

(17)

5.1 Probability function

105

(1)

5.2 Failure rate

106

(1)

5.3 Mean Time Between Failures

107

(1)

5.4 Quality control and testing

107

(1)

5.4.1 Life testing

107

(1)

5.4.2 Non-destructive testing

107

(1)

5.4.3 Destructive testing

108

(1)

5.5 Planning a graph

108

(5)

5.5.1 Identifying and assembling the data source

109

(1)

5.5.2 The data

109

(4)

5.6 How a manufacturer can `guarantee' quality

113

(1)

5.6.1 Random variability

113

(1)

5.6.2 Systematic variability

113

(1)

5.7 Quality-control charts

114

(1)

5.8 Sampling methods

115

(2)

5.8.1 Sampling by batches

115

(1)

5.8.2 Sampling by attributes

116

(1)

5.8.2.1 Inspection by attributes

116

(1)

5.8.2.2 Inspection by variables

116

(1)

5.8.2.3 Comparison between inspection by attributes and inspection by variables

116

(1)

5.8.3 Random sampling

116

(1)

5.9 Other types of test

117

(2)

5.9.1 Lot-by-lot tests

117

(1)

5.9.2 Periodic tests

117

(1)

5.9.3 Assessed process average

117

(1)

5.9.4 Parts per million approach

118

(1)

5.10 Recommended further reading

119

(2)

Part 6 Maintenance and Control of a Quality System

121

(44)

6.1 Third party certification

122

(1)

6.1.1 Types of certification

122

(1)

6.1.2 Role of a certifying body

123

(1)

6.2 BSI certification

123

(1)

6.2.1 Consumer Protection Act 1987

123

(1)

6.2.2 Kitemark

124

(1)

6.3 Commercial benefits

124

(3)

6.3.1 BSI Quality Assurance

125

(1)

6.3.2 National Accreditation Council for Certification Bodies

126

(1)

6.4 BS 9000

127

(5)

6.4.1 Qualification approval

127

(1)

6.4.2 Capability approval

127

(1)

6.4.3 The various standards making up BS 9000

128

(2)

6.4.3.1 BS 9000: Part 1

128

(1)

6.4.3.2 BS 9000: Part 2

128

(1)

6.4.3.3 BS 9000: Part 3

128

(1)

6.4.3.4 BS 9000: Part 4

128

(1)

6.4.3.5 BS 9000: Part 5

128

(1)

6.4.3.6 BS 9000: Part 6

129

(1)

6.4.3.7 BS 9000: Part 7

129

(1)

6.4.3.8 BS 9000: Part 8: Section 8.1

129

(1)

6.4.3.9 BS 9000: Part 8: Section 8.2

129

(1)

6.4.4 European and international equivalents

130

(1)

6.4.4.1 The CECC

130

(1)

6.4.4.2 IECQ

130

(1)

6.4.5 CODUS

130

(2)

6.5 BSI schemes

132

(3)

6.5.1 British Approvals Service for Electric Cables

132

(1)

6.5.2 BASEC markings

132

(1)

6.5.3 Validation of manufacturers data scheme

133

(1)

6.5.4 Service Industries Scheme

133

(1)

6.5.5 UK Certification Authority for Reinforced Steels

134

(1)

6.5.6 BSI Registration of Licensees

135

(1)

6.6 International harmonization of standards

135

(1)

6.6.1 CB scheme

135

(1)

6.7 CCA Scheme

136

(1)

6.8 UK Accreditation Service

137

(2)

6.8.1 The role of accereditation

139

(1)

6.8.2 Identifying an accredited body

139

(1)

6.9 MUAHAG

139

(1)

Appendix 6A: The BSI Kitemark

140

(5)

6A.1 The use of the Kitemark

141

(2)

6A.1.1 The Kitemark on a product

141

(1)

6A.1.2 The Kitemark on a product sold or advertised under another firm's name

142

(1)

6A.1.3 The Kitemark and ISO 9000

142

(1)

6A.2 The French equivalent of the Kitemark

143

(2)

Appendix 6B: The CE mark

145

(6)

6B.1 Telecommunications products

146

(1)

6B.1.1 The TTE Directive

146

(1)

6B.1.2 The EMC Directive

147

(1)

6B.1.3 The Low Voltage Directive

147

(1)

6B.2 Machinery Safety Directive

147

(1)

6B.3 National approval

148

(1)

6B.4 Pan-European approval

148

(1)

6B.5 Displaying the CE mark

148

(2)

6B.6 Keymark

150

(1)

Appendix 6C: Certification services for manufacturers of electrical equipment for Canada

151

(1)

6C.1 Product certification

151

(1)

6C.2 Special acceptance

152

(1)

6C.3 Consultancy service

152

(1)

6C.4 Multiple listing

152

(1)

Appendix 6D: The European Organization for Quality

152

(1)

Appendix 6E: Standards used for procurement and MOD contracts

153

(1)

6E.1 Standards used for procurement

154

(1)

6E.2 MOD contracts

154

(1)

Appendix 6F: The EMC Directive

154

(11)

6F.1 Objectives

154

(1)

6F.2 Application

154

(1)

6F.3 Requirements

155

(1)

6F.4 Assessment procedures

155

(1)

6F.5 Assessment bodies

155

(1)

6F.6 Conformity mode

155

(1)

6F.7 Emission limits

155

(1)

6F.8 EMC-related standards

156

(4)

6F.8.1 EN 55022

156

(1)

6F.8.2 EN 50081: Part 1

156

(1)

6F.8.3 EN 50082: Part 1

156

(1)

6F.8.4 IEC 801: Part 1

157

(1)

6F.8.5 IEC 801: Part 2

157

(1)

6F.8.6 IEC 801: Part 3

157

(1)

6F.8.7 IEC 801: Part 4

158

(1)

6F.8.8 IEC 601: Part 4

158

(1)

6F.8.9 EN 55024

158

(1)

6F.8.10 EN 45001

158

(1)

6F.8.11 EN 45002

158

(1)

6F.8.12 EN 45003

159

(1)

6F.8.13 EN 45004

159

(1)

6F.8.14 EN 45011

159

(1)

6F.8.15 EN 45012

159

(1)

6F.8.16 EN 45013

160

(1)

6F.8.17 EN 45014

160

(1)

6F.9 Other related standards

160

(1)

6F.10 Enforcement of the EMC Directive

161

(1)

6F.11 EMC testing: a comparison of the test alternatives

162

(3)

Part 7 Availability and Interoperability of Standards

165

(37)

7.1 International, regional and national standards

166

(1)

7.1.1 International standards

166

(1)

7.1.2 Regional standards

166

(1)

7.1.3 National standards

167

(1)

7.2 European standardization

167

(26)

7.2.1 Records

167

(1)

7.2.2 Data retrieval systems: CD-ROM

168

(3)

7.2.3 Databases and on-line information services

171

(1)

7.2.3.1 ISONET Information System

171

(1)

7.2.4 British Standards Institution

172

(8)

7.2.4.1 Library copies of British Standards

172

(2)

7.2.4.2 Customer Services and Information Centre

174

(1)

7.2.4.3 BSI library

174

(1)

7.2.4.4 Language Service Centre

175

(1)

7.2.4.5 PLUS

175

(1)

7.2.4.6 PERINORM

176

(1)

7.2.4.7 BSI Testing

177

(1)

7.2.4.8 BSI publications

177

(1)

7.2.4.9 The BSI electronic book on quality management systems

178

(1)

7.2.4.10 BSI contact addresses

178

(2)

7.2.5 Technical Indexes

180

(4)

7.2.5.1 Electronic Quality Assurance Documents Service on CD-ROM

180

(1)

7.2.5.2 British Defence Documents Service on CD-ROM

181

(1)

7.2.5.3 Nato Documents Service on CD-ROM

181

(1)

7.2.5.4 Germany: DIN (Deutsches Institute fur Normung e.V.) standards on CD-ROM

181

(1)

7.2.5.5 France: AFNOR (Association Francaise de Normalisation) standards on CD-ROM

182

(1)

7.2.5.6 Saudi Arabia: Saudi Arabian Standards Organization (SASO)

182

(1)

7.2.5.7 Australia: Standards Association of Australia (SAA)

182

(1)

7.2.5.8 World-wide Standards Service on CD-ROM

182

(1)

7.2.5.9 RAPIDOC

183

(1)

7.2.6 Infornorme London Information

184

(9)

7.2.6.1 Standards Infodisk

185

(1)

7.2.6.2 Standards Express

185

(1)

7.2.6.3 ILI's Tailored Updating Service

185

(1)

7.2.6.4 ILI's Customized Searches

186

(1)

7.2.6.5 International Telegraph and Telephone Consultant Committee Blue Book

186

(1)

7.2.6.6 EC Infodisk

186

(3)

7.2.6.7 Eurolaw CD-ROM

189

(4)

7.3 Other international standards, specifications, documentation and information

193

(4)

7.3.1 IEEE Standards Catalogue

193

(1)

7.3.2 The TickIT Scheme for software quality systems

193

(2)

7.3.3 NATO

195

(2)

7.4 Other National standards

197

(5)

7.4.1 Belgium

197

(1)

7.4.2 France

197

(1)

7.4.3 Italy

198

(1)

7.4.4 Norway

198

(1)

7.4.5 Switzerland

199

(1)

7.4.6 The UK

199

(3)

References

202

(3)

Glossary of terms

205

(14)

Acronyms and abbreviations

219

(5)

Index

224

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.

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