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GHTF/SG3/N18:2010 GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)

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标准简介

GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[附网盘链接]是Study Group 3于4 November 2010发布的GHTF标准，适用于世界。

标准截图

GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[附网盘链接]
GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[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

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 doc-

ument 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, in-

corporation 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.

Introduction

This guidance document is intended for medical device manufacturers and regulatory authorities.

It is intended for educational purposes and is not intended to be used to assess or audit compli-

ance with regulatory requirements. It is expected that the reader is familiar with regulatory Qual-

ity Management System (QMS) requirements within the medical devices sector.

For the purposes of this document it is assumed that the medical device manufacturer has a QMS

which requires the manufacturer to have documented processes to ensure that medical devices

placed on the market are safe and effective. For example ISO13485 Medical Devices – Quality

Management Systems – Requirements for regulatory purposes, Japanese Ministerial Ordinance

on Standards for Manufacturing Control and Quality Control for Medical Devices and in vitro

1 2

Diagnostics (MHLW Ministerial Ordinance No. 169), the FDA Quality System Regulation 21

CFR Part 820 or the respective quality system requirements of the European medical Device Di-

rectives.

For this purpose the manufacturer will establish processes and define appropriate controls for

measurement and analysis to identify nonconformities and potential nonconformities. Also, the

manufacturer should establish processes defining when and how corrections, corrective actions,

or preventive actions should be undertaken. These actions should be commensurate with the sig-

nificance or risk of the nonconformity or potential nonconformity.

The terms risk, risk management and related terminology utilized within this document are in

accordance with ISO 14971 “Medical Devices-Application of Risk Management to Medical De-

vices.”

The acronym “CAPA” will not be used in this document because the concept of corrective action

and preventive action has been incorrectly interpreted to assume that a preventive action is re-

quired for every corrective action.

1

Japanese Ministry of Health Labor and Welfare

2

US Food and Drug Administration

November 4, 2010 Page 3 of 26

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