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GHTF GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)

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GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)[附网盘链接]
GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)[附网盘链接](截图)

 

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标准部分原文

Study Group 3 Final Document GHTF/SG3/N19:2012

Preface

This document was produced by the Global Harmonization Task Force (GHTF), a voluntary

group of representatives from medical device regulatory authorities 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. It is expected that the

reader is proficient with the requirements of ISO 13485:2003.

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 document is intended for regulatory authorities and auditing organizations. It introduces a

standardized nonconformity grading system for regulatory purposes with a Regulatory Audit In-

formation Exchange Form providing consistent audit information in order to enable exchange

among regulatory authorities.

Currently, the significance of a nonconformity related to a medical device manufacturer’s Quali-

ty Management System (QMS) may vary between regulatory authorities and auditing organiza-

tions. All parties will benefit from the use of a standardized and transparent grading system of

QMS nonconformities. This will build the confidence necessary for the potential mutual accep-

tance of the results of a regulatory audit.

The major and minor classification of nonconformities commonly used does not provide enough

detail for global information exchange. Therefore the terms major and minor nonconformity will

not be defined nor utilized in this document. The intent of this new grading system for regulatory

purposes is to support the exchange of audit results that go beyond the binary concept of major

and minor to a 5 level grading system of nonconformities.

The regulatory authorities can determine how the audit information provided in the Regulatory

Audit Information Exchange Form will be utilized within their jurisdiction. Regulatory authori-

ties may also consider other data sources in addition to the outcome of the regulatory audits such

as product evaluations, recalls, vigilance reports, etc. for regulatory oversight.

1.0 Scope

This document provides a method to present outcomes of regulatory audits that can be used by

regulatory authorities for information exchange. It introduces a nonconformity grading system

for regulatory purposes with a Regulatory Audit Information Exchange Form providing standar-

dized results.

nd

November 2 , 2012 Page 3 of 16

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