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Implementation, 7
design rules, 279–84
GCQMS, 303
mandatory effective requirement, 185–86
Implicit requirements, 80
Implied documentation, 35, 43
Improvement (Section 8.5 GCQMS manual), 344–47
continual, 344
corrective action, 345–47
preventative action, 347
See also GCQMS manual
Information channels, 44
Infrastructure (GCQMS manual), 320
In-House Calibration Work instruction, 36
Initial assessment, 229–31
Integrated manual configuration, 126–29
comparison, 128–29
implementation, 127–28
quality policy statement forms, 126
schematic representation, 127
See also Manual configurations; Quality manual
Internal audits, 339–40
ISO 9000
certified vendor, 82
hierarchical drivers, 40–42
management representative, 212
quality plans, 156–60
responsiveness, difficult areas, 237
stewardship, 205–7
stewardship and team leader summary, 355
stewardship distribution, 213–14
tiers, 36
ISO 9000:2000
documentation, 26
schema, 24–25
ISO 9001:1994
biggest change in, 235–36
QSR relationship with, 119–20
ISO 9001:2000 QMS, 11–16
auditors, 107
Baldridge criteria vs., 27
biggest change, 235–36
certification assessment, 107–9
certification gates, 56
certification impact, 12
certification purpose, 14
changes, 274–75
clause implementation, 23
customer orientation, 19–20
descriptive requirement, 74
design context, 11–12
design rules, 280–82
Element 4.2.3: Control of Documents Quality Manual Requirements checklist, 359–60
forms linkage scheme, 170
hierarchical drivers, 40–42
international/national recognition, 8
mandatory documentation requirements, 29
most difficult critical issues, 110
operational model, 14–16
in practice, 13
process model, 14–16
QSR relationship with, 119–20
quality management principles, 13
quality manual status, 111–12
quality specification, 19
readiness chart, 208–9
sections, 15, 90
umbrella-documentation complexity, 28
value chain, 116
ISO 9004:2000, 25
ISO 10013:1995, 252
ISO 13485 Standard, 117, 136
ISO 19011, 26
ISO Guidance on the Documentation Requirements of ISO 9001:2000, 170
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