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Doc #
Document Description
21 CFR - Parts 820, Quality System Regulation
Food and Drug Administration, Code of Federal Regulations
ANSI/ISO/ASQC-Q10011-1-1994,
Q10011-2-1994, Q10011-3-1994
American National Standard - Guidelines
for Auditing Quality Systems
ANSI/ISO/ASQC Q9001-1994
American National Standard - Quality Systems - Model
for Quality Assurance in Design, Development, Production, Installation
and Servicing
BS EN 46001 : 1997
Specification for Application of EN ISO 9001 to the
Manufacture of Medical Devices
ICH Harmonised Tripartite Guidelines
27 October 1993
27 October 1993
Stability Testing of New Drug Substances and Products
IEEE STD 1012 - 1986
IEEE Standard for Software Verification and Validation
Plans
IS/EN 724 : 1995
Guidance on the Application of EN 29001 and EN 46001
and of EN 29002 and EN 46002 for Non-Active Medical Devices
IS/EN 928 : 1996
In Vitro Diagnostic Systems - Guidance on the Application
of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for In Vitro Diagnostic
Medical Devices
ISO 9000-3
International Standard - Quality Management and Quality
Assurance Standards, Second Edition 1997-12-15
ISO 10007 1995-04-15 (E)
International Standard - Quality Management - Guidelines
for Configuration Management
ISO/TR 10014:1998-08-01 (E)
Technical Report - Guidelines for Managing the Economics
of Quality