首页 > GHTF标准 > GHTF SG4 - GuidelinesRegulatory AuditingManufacturer ControlGHTF/SG4/N84:2010

GHTF/SG4/N84:2010 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)

赵静曼 2/4/2022 浏览 308 GHTF/SG4/N84:2010 世界范围

标准简介

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)[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，适用于世界范围。

标准截图

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)[附网盘链接]
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)[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 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)[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 5: Audits of manufacturer control of suppliers

GHTF/SG4/N84 R13:2010 Study Group 4 - Final Document

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.

1.0 Introduction

This document follows on from GHTF/SG4/N28 Guidelines for Regulatory Auditing of Quality

Management Systems of Medical Device Manufacturers - Part 1: General Requirements and

GHTF/SG4/N30 Guidelines for Regulatory Auditing of Quality Management Systems of Medical

Device Manufacturers – Part 2: Regulatory Auditing Strategy.

It is based on the principle set out in Section 3 of GHTF/SG3/N17 Quality Management System –

Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers:

“Within existing regulatory frameworks the term “manufacturer” may be defined

differently. However, each regulatory authority ultimately holds one “manufacturer” of

medical devices or entity primarily responsible for meeting regulatory quality management

system requirements. This “manufacturer” or entity, that has the ultimate responsibility for

its quality management system, cannot relinquish (contractually or otherwise) its obligation

and responsibility over any or all functions within the quality management system. This

means the responsibility for complying with the quality management system requirements

cannot be delegated to any supplier of products and services.”

2.0 Scope

This document gives guidance for the auditing of a manufacturer’s purchasing controls, including

the audit of the suppliers when suppliers should be audited and what a supplier audit should cover,

adding to the guidance given in GHTF/SG4/N28 and GHTF/SG4/N30.

3.0 Rationale

This guideline will provide additional information about audit strategy to regulators, auditing

organizations and auditors for auditing a manufacturer’s purchasing controls and

receiving/incoming acceptance activities, as well as on the performance of audits at the

manufacturer’s supplier(s).

The main aim of the guidance is to promote consistency in conducting audits – a necessity for

harmonization and mutual recognition of audit results.

August 27, 2010 Page 3 of 8

网盘链接

百度网盘：https://pan.baidu.com/s/17ryYnw76hEt3DYDI4Kjo0A
提取码：q9r6

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：74.7554 毫秒

相关评论

相关文章