Index_D


D

Data Analysis (Section 8.4 GCQMS manual), 344

Demonstration, 7

Design and Development (Section 7.3 GCQMS manual), 324–28

design flow, 324

development changes, 327–28

guidelines, 324

inputs, 326

planning, 325

review, 326

validation, 327

verification, 327

See also GCQMS manual

Design history file (DHF), 258

Device history record (DHR), 158

Device master record (DMR), 158

Direct paraphrasing, 252–53

attribute comparison, 253

defined, 252

discussion, 252–53

See also Paraphrasing

Direct sequence, 90–112

assessment implications, 107–9

checklist, 109

cut-and-paste technique, 93–105

fill-in process, 106–7

manual:2000 creation, 92

quality manual status, 111–12

readiness concept, 109–12

sequence comparison, 121–23

stand-alone manuals, 124

upgrade manual:2000 creation, 93

See also Quality manual

Documentation, 7

decision matrix, 261

design rules, 279–84

form, 260

four-tier pyramid, 37–42

growth tendency, 40

implied, 35, 43

ISO 9001:1994, 36

ISO 9001:2000 requirements, 29

procedures and, 153

recommended, 35–46

registrar's required, 35

regulatory required (compliance), 35

requirements overview, 35–37

structure, 28

system methods comparison, 248–49

taxonomy, recommendation, 36–37

taxonomy, this book, 30

waterfall effect, 40, 41

See also Forms; Procedures; Process documents; Quality manual

Documentation Requirements (Section 4.2 GCQMS manual),300–306

control of documents, 303–5

control of records, 305–6

general requirements, 300–301

quality manual, 301–3

See also GCQMS manual

Document change order (DCO), 167

Documents

control of, 303–5

creation order, 247–50

effective, producing, 250

engineering, 249

historical, 174–75

hub, 197–99

LAM control, 260

linking reader to, 268

mandatory, 35, 42–43, 170–74, 179–80

number of, 44

revision control, 304–5

tier II/tier III format differences, 154–56




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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