文档介绍：GHTF/SG4(98)39
GLOBAL HARMONISATION
TASK FORCE
GUIDELINES FOR REGULATORY AUDITING
OF QUALITY SYSTEMS OF
MEDICAL DEVICE MANUFACTURERS
PART 1: GENERAL REQUIREMENTS: 1998
FINAL DOCUMENT
Study Group 4: auditing.
Guidelines for regulatory auditing of quality systems of medical device manufacturers:
Part 1 General requirements: 1998 Final document
Contents
Foreword 3
1. Introduction 4
2. Scope 5
3. Reference documents 5
4. Definitions 5
5. General principles for anisations 7
6. Audit objectives 9
7. Audit scope 10
8. Types of audit 10
9. Roles and responsibilities 12
10. Audit team 15
11. Audit process 18
12 Corrective action follow-up 24
Annex
A: List anisations represented on Study Group 4: 25
Auditing
B: List of references to the relevant regulations applicable to 26
manufacturers of medical devices and which include
compliance with quality system requirements
C: Relevant anisations responsible for 27
enforcement of the regulations listed in Annex B
D: Definitions of 'manufacturer' applicable to the regulations 28
listed in Annex B
E: References 30
7 July 1998 page 2 of 30
Study Group 4: auditing.
Guidelines for regulatory auditing of quality systems of medical device manufacturers:
Part 1 General requirements: 1998 Final document
Foreword
“Guidelines for regulatory auditing of quality systems of medical device manufacturers:
part 1; general requirements” has been endorsed by the Global Harmonisation Task
Force as a Final Document. It has been prepared by Study Group 4, auditing and is a
consensus.
In February 1998, the GHTF Proposed Document version (SG4(98)24) was made
available to other agencies through the participating regulatory bodies and trade
associations in order to ments. At the same time, it was also made available,
in the public domain, through the UK Medical Devices Agency home page on the
. Study Group 4 reviewed ments received and as a result amendments
were incorporated into this document.