Index_I


I

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




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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