Excellence Beyond Compliance

Index

A

Acceptance activities, 183

Annex SL model, 129

in ISO 9001:2015, 33

multiple management standards, 129–132

quality management standards, 132

Asia, medical device regulation, 10–11

Asian Harmonization Working Party, 10–11, 12

Auditors, 41, 67–68

external, 30, 40, 71

improvement of QMS, 67–68

number of, internal audits, 102–103

Audits

external, 81, 153

follow-up, 153

internal, see Internal audits

quality, 81–82

Augmented FDA QSIT approach, 33

Australia, medical device regulation, 11

B

Business issue, 80, 200

C

Canadian Guidance Document GD210, 8, 61

Canadian QMS requirements, 7–8

Canadian Standards Association, 89

CAPA, see Corrective and preventive action

Capability maturity model, 110

“Certification body”, 107

CGMP framework, see Current ...