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Guidelins for Regulatory Auditing of Quality Systems of Medical Device Manufacturers.doc

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Guidelins for Regulatory Auditing of Quality Systems of Medical Device Manufacturers

GHTF/SG4/N(99)24R3:2002 FINAL DOCUMENT Global Harmonization Task Force Title: Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7) Authoring Group: Study Group 4 Date: 12 May 2002 Rita Maclachlan, GHTF Chair The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force. Copyright ? 2002 by the Global Harmonization Task Force Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force. Table of Contents 1.0 Introduction 4 2.0 References 4 3.0 Definitions 4 4.0 Scope 5 5.0 Pre Audit 5 6.0 Observed Audit Process 6 7.0 Post Audit 6 Introduction This document has