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GHTF/SG4/N83:2010 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)

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标准简介

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)[附网盘链接]是Study Group 4 of the Global Harmonization Task Force于August 27, 2010发布的GHTF标准，适用于全球。

标准截图

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)[附网盘链接]
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Part 4: Multiple Site Auditing

GHTF/SG4/N83R6:2010 Study Group 4 - Final Document

Table of Contents

Preface 4

1.0 Introduction 4

2.0 Scope 5

3.0 Purpose 5

4.0 Rationale 5

5.0 References 5

6.0 Definitions 6

7.0 Audit program for a manufacturer with multiple sites 7

7.1 Objectives and criteria of audit program 9

7.1.1 Audit program objectives 9

7.1.2 Audit criteria 9

7.2 Scope of audit program 9

7.3 Preparation of audit program 10

7.3.1 Objectives, criteria and scope of individual site audits 10

7.3.2 Sequence of audits 11

7.3.3 Determination of resource needs 12

7.3.4 Determination of communication and reporting needs 12

7.3.5 Completion of audit program preparation 13

8.0 Execution of audit program 13

8.1 Execution of individual site audits 14

8.1.1 Opening meeting 14

8.1.2 Auditing of subsystems 14

8.1.2.1 Management subsystem 14

8.1.2.2 Design and development subsystem 15

8.1.2.3 Product documentation subsystem 15

8.1.2.4 Production and process controls subsystem 15

8.1.2.5 Corrective and preventive actions - CAPA subsystem 15

8.1.2.6 Purchasing controls subsystem 15

8.1.2.7 Documentation and records subsystem 16

8.1.2.8 Customer related processes subsystem 16

8.1.3 Closing meetings 17

8.1.4 Audit Report 17

8.2 Audit program synthesis 17

8.2.1 Communication of overall findings 17

8.2.2 Synthesis report 18

8.3 Audit program completion 18

9.0 Audit follow-up 19

10.0 Audit program review 19

10.1 Audit program effectiveness 19

10.2 Modifying the audit program 20

10.3 Corrective and corrective action 20

August 27, 2010 Page 2 of 21

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