ISO 9000: 2000: An A-Z Guide

175 Pages·2002·1.082 MB·English

by  David Hoyle

ISO 9000: 2000
An A–Z Guide

ISO 9000: 2000
An A–Z Guide
David Hoyle
OXFORD AMSTERDAM BOSTON LONDON NEW YORK PARIS
SAN DIEGO SANFRANCISCO SINGAPORE SYDNEY TOKYO
Butterworth-Heinemann
An imprint of Elsevier Science
Linacre House, Jordan Hill, Oxford OX2 8DP
225 Wildwood Avenue, Woburn, MA 01801-2041
First published 2003
Copyright © 2003, David Hoyle. All rights reserved
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ISBN 0 7506 5844 4
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Printed and bound in Great Britain
A . . . . . .1...............................................................
Acceptance criteria . . . . .1....................................
Accreditation . . . .1...............................................
Accreditation body.......................................... 2
Adequacy........................................................ 2
Analysis of data............................................... 3
Applicable....................................................... 4
Appropriate..................................................... 5
Approved......................................................... 5
Assessment.................................................... 6
Assessor......................................................... 7
Assurance....................................................... 7
Audit................................................................ 8
Audit criteria.................................................... 9
Audit programme............................................ 9
Audit results.................................................... 10
Audit scope..................................................... 10
Auditors........................................................... 11
Authority.......................................................... 11
Authorized....................................................... 12
Awareness...................................................... 13
B1..6...................................................................
Benchmarking1..6...............................................
Best practice................................................... 16
Breakthrough.................................................. 16
Business management process...................... 17
Business management system....................... 18
Business process............................................ 19
C2..1...................................................................
Calibration2..1.....................................................
Certification2..1...................................................
Certification body............................................ 22
Codes of practice............................................ 23
Collection of data............................................ 23
Commitment.................................................... 24
Common cause variation................................ 25
Competence.................................................... 26
Concession..................................................... 27
Continual improvement................................... 28
Continuous improvement................................ 29
Contract.......................................................... 30
Control............................................................ 31
Control before, during and after an event....... 32
Control charts.................................................. 33
Controlled conditions...................................... 33
Controlled distribution..................................... 35
Controlled documents..................................... 35
Corrective action............................................. 35
Corrective maintenance.................................. 37
Critical success factors................................... 38
Cross-functional team..................................... 39
Culture and climate......................................... 39
Customer........................................................ 40
Customer communication............................... 40
Customer complaints...................................... 41
Customer expectations................................... 41
Customer feedback......................................... 42
Customer focus............................................... 42
Customer needs.............................................. 43
Customer property.......................................... 43
Customer requirements.................................. 44
Customer satisfaction..................................... 45
Customer surveys........................................... 46
D . . .4..8................................................................
Data . . .4..8...........................................................
Demonstrate . . .4..8..............................................
Department..................................................... 49
Design............................................................. 49
Design and development................................ 49
Design changes.............................................. 50
Design inputs.................................................. 51
Design outputs................................................ 51
Design planning.............................................. 52
Design review................................................. 53
Design validation............................................. 54
Design verification........................................... 55
Determining requirements............................... 57
Document approval......................................... 58
Document change request.............................. 58
Document control............................................ 59
Document identification................................... 60
Document review............................................ 60
Document revision.......................................... 61
Document security.......................................... 61
Documented procedures................................. 62
E6..4...................................................................
Effectiveness of the system6..4..........................
Ensure............................................................. 65
Environmental factors of the work
environment.................................................... 65
Establish and maintain.................................... 66
Establishing a management system............... 66
Evaluation....................................................... 67
Evidence of conformity.................................... 68
Exclusions....................................................... 68
External documents, control of....................... 69
F . . . .7..1...............................................................
Factual approach . . . .7..1......................................
Failure mode effects analysis (FMEA) . . . .7..1......
First-party audit............................................... 72
Follow-up audit................................................ 72
Functions........................................................ 73
I7..4....................................................................
Identification of records7..4.................................
Identifying document changes7..4......................
Identifying processes...................................... 75
Implementation audit....................................... 75
Infrastructure................................................... 76
Inspection........................................................ 76
Inspection authority......................................... 77
Intellectual property......................................... 77
Interested party............................................... 78
Internal audit................................................... 79
Internal communication................................... 80
Internal customer............................................ 81
Invitation to tender.......................................... 81
Involvement of people..................................... 82
ISO 9000......................................................... 82
ISO 9000 family.............................................. 83
ISO 9001......................................................... 83
ISO 9004......................................................... 84
L8..6...................................................................
Leadership8..6....................................................
M8..7..................................................................
Maintenance8..7.................................................
Management commitment.............................. 88
Management representative........................... 89
Management review........................................ 90
Marketing process........................................... 92
Measurement.................................................. 92
Measurement capability.................................. 92
Measurement process.................................... 92
Measurement uncertainty............................... 94
Mission............................................................ 94
Modifications................................................... 95
Monitoring....................................................... 95
Monitoring and measuring devices................. 96
Motivation........................................................ 97
Mutual beneficial supplier relationships.......... 97
N9..8...................................................................
Naming processes9..8........................................
Nonconforming product9..8.................................
O.1..0..0................................................................
Objective1..0..0.....................................................
Objective evidence.1..0..0.....................................
Obsolete documents1..0..0...................................
Order fulfilment process1..0..0..............................
Organizational goals....................................... 101
P1..0..2.................................................................
Physical factors of the work environment1..0..2...
Plan................................................................. 103
Planned arrangements.................................... 103
Policy.............................................................. 103
Policy audit...................................................... 104
Potential nonconformity.................................. 105
Predictive maintenance................................... 105
Pre-qualification of suppliers........................... 105
Preservation of product................................... 106
Prevent............................................................ 107
Preventive action............................................ 107
Preventive maintenance................................. 108
Procedure....................................................... 108
Process........................................................... 109
Process approach........................................... 109
Process audit.................................................. 110
Process capability........................................... 111
Process control............................................... 112
Process description......................................... 112
Process management..................................... 113
Process model................................................ 114
Process parameters........................................ 115
Product............................................................ 115
Product audit................................................... 115
Product identification....................................... 116
Product realization.......................................... 116
Production....................................................... 117
Project audit.................................................... 118
Proprietary designs......................................... 118
Psychological factors of the work
environment.................................................... 118
Purchaser........................................................ 119
Purpose of an organization............................. 119
Q.1..2..0................................................................
Quality1..2..0.........................................................
Quality assurance1..2..0.......................................
Quality control1..2..0.............................................
Quality improvement1..2..0...................................
Quality management principles....................... 121
Quality management system.......................... 121
Quality manual................................................ 122