Index_S

S

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