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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
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