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Quality and Standards in Electronics

Author(s): Tricker
ISBN10: 0750625317
ISBN13: 9780750625319
Cover: Hardcover
 
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SummaryTable of Contents
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.

This book ensures that the engineers and managers in organizations are aware of all national and international necessities, know the current status of these regulations and standards and where to obtain them. Covers BS/EN/ISO 9000 systems.
Foreword xv(4)
Preface xix(1)
Acknowledgements xx
Part 1 The Importance of Quality Control and Quality Assurance 1(15)
1.1 Quality control
2(2)
1.2 Quality assurance
2(2)
1.3 Specifications
4(4)
1.3.1 The significance of specifications
4(1)
1.3.2 Types of specification
4(2)
1.3.2.1 General specification
4(1)
1.3.2.2 Overall performance specification
5(1)
1.3.2.3 Standard specification
6(1)
1.3.3 Manufacturer's responsibilities
6(1)
1.3.4 Purchaser's responsibilities
7(1)
1.4 Quality assurance during a product's life cycle
8(5)
1.4.1 Design stage
8(2)
1.4.2 Manufacturing stage
10(1)
1.4.3 Acceptance stage
11(1)
1.4.4 In-service stage
11(2)
1.5 Benefits and costs of quality assurance
13(1)
1.6 Costs of quality failure
14(1)
1.6.1 The manufacturer
14(1)
1.6.2 The purchaser
15(1)
1.7 Recommended further reading
15(1)
Part 2 Quality System 16(22)
2.1 Basic requirements of a quality system
17(2)
2.2 Quality-system principles
19(3)
2.3 Quality-system reliability
22(1)
2.4 Quality manual
22(1)
2.5 Quality plan
23(1)
2.6 ISO 10005
24(4)
2.6.1 Management responsibility
25(1)
2.6.2 Contract review
25(1)
2.6.3 Design control
25(1)
2.6.4 Document and data control
26(1)
2.6.5 Purchasing
26(1)
2.6.6 Customer-supplied product
26(1)
2.6.7 Product identification and traceability
26(1)
2.6.8 Process control
26(1)
2.6.9 Inspection and testing
27(1)
2.6.10 Inspection, measuring and test equipment
27(1)
2.6.11 Non-conforming service/product
27(1)
2.6.12 Other considerations
28(1)
2.7 Quality records
28(1)
Appendix 2A: Quality organizational structure -- management
29(2)
Appendix 2B: Quality organizational structure -- quality assurance personnel
31(7)
2B.1 Quality manager
31(2)
2B.1.1 General functional description
31(1)
2B.1.2 Tasks
32(1)
2B.1.3 Responsibilities
32(1)
2B.1.4 Co-ordination
33(1)
2B.2 Chief quality-assurance inspector
33(2)
2B.3 Section quality-assurance inspectors
35(1)
2B.4 Quality-assurance personnel
36(1)
2B.5 Quality-assurance resources
37(1)
Part 3 ISO 9000 38(51)
3.1 Interoperability of standards
39(2)
3.2 The demand for standardization in support of quality systems
41(1)
3.3 The background to the ISO 9000 set of quality standards
42(1)
3.4 Future revisions of ISO 9000
43(1)
3.5 ISO 9000
44(1)
3.6 The ISO 9000 series
44(2)
3.6.1 ISO 9000/1
45(1)
3.6.2 ISO 9000/2
45(1)
3.6.3 ISO 9000/3
45(1)
3.6.4 ISO 9000/4
46(1)
3.6.5 ISO 9000, 9002 and 9003
46(1)
3.7 ISO 9004
46(1)
3.7.1 ISO 9004/1
46(1)
3.7.2 ISO 9004/2
47(1)
3.7.3 ISO 9004/3
47(1)
3.7.4 ISO 9004/4
47(1)
3.8 Choosing the relavant part of ISO 9000
47(5)
3.8.1 ISO 9001
48(1)
3.8.2 ISO 9002
48(3)
3.8.3 ISO 9003
51(1)
3.9 Assistance in obtaining a quality system
52(1)
3.9.1 Government assistance
52(1)
3.9.1.1 DTI business links
52(1)
3.9.1.2 National Quality Information Centre
53(1)
3.9.2 Assistance for the small company
53(1)
3.10 Recommended further reading
53(3)
Appendix 3A: Checklist for ISO 9000
56(6)
Appendix 3B: The elements of ISO 9000
62(27)
3B.1 Management responsibility (ISO 9001: Section 4.1)
62(1)
3B.2 Quality system (ISO 9001: Section 4.2)
63(2)
3B.2.1 Procedures
63(1)
3B.2.2 The procedures manual
64(1)
3B.2.3 Working instructions
65(1)
3B.3 Contract review (ISO 9001: Section 4.3)
65(1)
3B.3.1 The contract document
65(1)
3B.3.2 Contract review
65(1)
3B.4 Design control (ISO 9001: Section 4.4)
66(4)
3B.4.1 Design input
66(1)
3B.4.2 Process control and instructions
67(1)
3B.4.3 Marketing implications
67(1)
3B.4.4 Components, parts and materials
68(1)
3B.4.5 Specifications and tolerances
68(1)
3B.4.6 Health and safety
68(1)
3B.4.7 Computers
69(1)
3B.4.8 Design output
69(1)
3B.4.9 Design review
69(1)
3B.4.10 Design process review
69(1)
3B.4.11 Design verification and review
70(1)
3B.5 Document and data control (ISO 9001: Section 4.5)
70(1)
3B.6 Purchasing (ISO 9001: Section 4.6)
70(1)
3B.6.1 Control of a product or service obtained from a third party
71(1)
3B.7 Customer-supplied product (ISO 9001: Section 4.7)
71(1)
3B.8 Product identification and traceability (ISO 9001: Section 4.8)
72(1)
3B.9 Process control (ISO 9001: Section 4.9)
72(1)
3B.10 Inspection and testing (ISO 9001: Section 4.10)
72(2)
3B.10.1 Goods inwards
72(1)
3B.10.2 Inspection and testing
73(1)
3B.10.3 Inspection procedures
73(1)
3B.11 Inspection, measuring and test equipment (ISO 9001: Section 4.11)
74(1)
3B.11.1 Control of inspection, measuring and testing equipment
74(1)
3B.11.2 Maintenance
74(1)
3B.11.3 Calibration
74(1)
3B.12 Inspection and test status (ISO 9001: Section 4.12)
75(1)
3B.12.1 Production control
75(1)
3B.12.2 Product testing
75(1)
3B.12.3 Special processes
76(1)
3B.21 Control of non-conforming product (ISO 9001: Section 4.13)
76(4)
3B.13.1 Material control and traceability
76(1)
3B.13.2 Control of non-conformity
76(4)
3B.14 Corrective action (ISO 9001: Section 4.14)
80(3)
3B.14.1 Concessions and approvals
80(1)
3B.14.2 Concession scheme
81(1)
3B.14.3 Defects and defect reports
81(1)
3B.14.4 Bonded store
82(1)
3B.15 Handling, storage, packaging and delivery (ISO 9001: Section 4.15)
83(2)
3B.15.1 Storage
84(1)
3B.15.2 Delivery
84(1)
3B.16 Quality records (ISO 9001: Section 4.16)
85(1)
3B.16.1 Documentation
85(1)
3B.16.2 Logistic support
85(1)
3B.17 Internal quality audits (ISO 9001: Section 4.17)
85(1)
3B.17.1 Audit plan
86(1)
3B.18 Training (ISO 9001: Section 4.18)
86(1)
3B.19 Servicing (ISO 9001: Section 4.19)
87(1)
3B.20 Statistical techniques (ISO 9001: Section 4.20)
87(1)
3B.20.1 Records
88(1)
3B.21 Recommended further reading
88(1)
Part 4 How ISO 9000 Can be used to Check a Company's Quality System 89(15)
4.1 Internal audit
90(1)
4.1.1 Purpose
90(1)
4.2 Responsibility
91(1)
4.2.1 Method
91(1)
4.2.2 Results and achievements
91(1)
4.3 External audit
92(3)
4.3.1 Supplier evaluation
92(1)
4.3.2 Evaluation team
93(1)
4.3.3 Pre-evaluation meeting
93(1)
4.3.4 Study of the quality manual
94(1)
4.3.5 The evaluation
94(1)
4.3.5.1 Acceptable system control
95(1)
4.3.5.2 Weak system control
95(1)
4.3.5.3 Unacceptable system control
95(1)
4.3.5.4 DTI manufacturers lists
95(1)
4.4 The surveillance or quality audit visit
95(2)
4.4.1 Multiple evaluations and audits
97(1)
4.4.1.1 Secondary audit
97(1)
4.4.1.2 Third-party evaluation
97(1)
4.5 Assessment of quality-management systems
97(3)
4.5.1 Pre-assessment
98(1)
4.5.2 The assessment
98(1)
4.5.3 Reporting
98(1)
4.5.4 Approval
98(1)
4.5.5 Maintenance of approval
99(1)
4.5.6 Triennial reassessment
99(1)
4.5.7 System changes
99(1)
4.5.8 Confidentiality
99(1)
4.5.9 Suspension or withdrawal of approval
99(1)
4.5.10 Complaints and appeals
99(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

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