|
Scope of effort, 193–95
discussion, 194
estimates, 193–94
timeline example, 195
See also Quality manual
Sections, 15, 90
hub documents in, 199
labeling, 266
numbering, 90
QSR, 118
See also GCQMS manual
Sector-specific manuals, 132–38
accreditation board requirements, 132–33
Current Good Manufacturing Practices example, 134–36
EN46001/ISO 13485 example, 136–38
quality policy statements, 133–34
See also Quality manual
Sector-specific requirements
audit plan, 225–29
example 1, 226–27
example 2, 228
impact, 225, 226–27, 228
for software, 227
Sensible requirements, 186
Sentences, 265
Sequences
another standard's, 90, 117–21
comparison, 121–23
direct, 90–112
operational, 90, 114–17
Shewhart, 90, 112–14
See also Quality manual
SHALLS, 67–73
analysis, 67–73
analysis example, 72–73
appropriate response to, 67–68
defined, 67
denoting specific requirements, 73
duplicated, 68
effective, 70
effective number of, 69–71
expanded, 71, 73
explicit, 72, 88
implicit, 88
method to count, 71–73
nonapplicability of, 81–82
nonapplicable, positive approach to, 81–82
paraphrasing and, 68
QS-9000, 134
written as descriptive, 74
Shewhart cycle, 18, 20–23
act, 22–23
check, 22
do, 21–22
in manual configuration, 112–14
operational power, 23
by paragraph, 20
plan, 21
Shewhart sequence, 90, 112–14
as concept, 114
defined, 112
example, 115
illustrated, 113
problem areas, 114
sequence comparison, 121–23
See also Quality manual
Spell checkers, 269
Stand-alone configuration, 123–26
application to third-party assessments, 125
comparison, 128–29
defined, 123
direct-sequence, 124
dislocated quality policy statements, corrective actions, 125–26
inconsistency source, 125
quality policy statement imperative, 124
section references, 124
See also Manual configurations; Quality manual
Standards
establishment requirements, 3
examples, 11
relevance, 3–4
use, 4
See also specific standards
Stewards, 208–11
duties, 210
essential role, 209–11
information objectives, 211
summary, 355–56
See also Leadership
Suppliers
defined, 116
mutually beneficial relationships, 296
Systems history record (SHR), 158
Systems master record, 158
|