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1、GHTF/SG3/N19:2012FINAL DOCUMENTGlobal Harmonization Task ForceTitle: Quality management system -Medical devices - Nonconformity Grading System for Regulatory Purposes and Information ExchangeAuthoring Group: Study Group 3 of the Global Harmonization Task ForceDate: November 2nd, 2012Dr. Kazunari Asa
2、numa, GHTF ChairThis document was produced by the Global Harmonization Task Force, a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia.The document is intende
3、d to provide non-binding guidance to regulatory authorities 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 p
4、art 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 2012 by the Global Harmonization Task ForceTable of ContentsPreface 3Introduction 31.0Scope 32.0Def
5、initions 42.1 Manufacturer 42.2 Nonconformity 42.3 Quality management system (QMS) 43.0References 44.0General 54.1 Writing Nonconformities 54.2 Grading of Nonconformities 64.2.1 Step 1 Grading Matrix 74.2.2 Step 2 Grading -Escalation Rules94.3 Applying the Nonconformity Grading System 104.4 Regulato
6、ry Audit Information Exchange Form 114.5 Use of the Regulatory Audit Information Exchange Form 115.0Appendix A: Examples of statements of nonconformities 146.0Appendix B: Examples Illustrating Nonconformity Grading 15PrefaceThis document was produced by the Global Harmonization Task Force (GHTF), a
7、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 re
8、ader is proficient with the requirements of ISO 13485:2003.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
9、 or represent an endorsement of any kind by the Global Harmonization Task Force.IntroductionThis document is intended for regulatory authorities and auditing organizations. It introduces a standardized nonconformity grading system for regulatory purposes with a Regulatory Audit Information Exchange
10、Form providing consistent audit information in order to enable exchange among regulatory authorities.Currently, the significance of a nonconformity related to a medical devicQeuamlai-nufacturers ty Management System (QMS) may vary between regulatory authorities and auditing organizations. All partie
11、s 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 acceptance of the results of a regulatory audit.The major and minor classification of nonconformities commonly used does not provide
12、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
13、 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 authorities may also consider other data sources in addition to t
14、he outcome of the regulatory audits such as product evaluations, recalls, vigilance reports, etc. for regulatory oversight.1.0 ScopeThis document provides a method to present outcomes of regulatory audits that can be used by regulatory authorities for information exchange. It introduces a nonconform
15、ity grading system for regulatory purposes with a Regulatory Audit Information Exchange Form providing standardized results.The following are not included in the scope of this document: How to perform audits and prepare associated reports (see GHTF SG4 documents) How the Regulatory Audit Information
16、 Exchange Form will be utilized by regulatory authorities2.0 Definitions2.1 ManufacturerAny natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himse
