GHTF 质量管理系统-医疗设备 预防措施-QMS-Medical_Devices-Guidance_on_Corrective_Action_and_Preventive.pdfVIP

1 SG3(PD)/N18R8 2 3 4 5 6 7 8 9 10 11 12 PROPOSED DOCUMENT 13 Global Harmonization Task Force 14 15 16 17 Title: Quality management system –Medical Devices – Guidance on corrective ac- 18 tion and preventive action and related QMS processes 19 20 Authoring Group: Study Group 3 21 22 Date: 22nd September 2009 23 24 25 26 27 28 29 30 31 32 33 Guidance on corrective action and preventive action and related QMS processes SG3(PD)/N18R8 34 Table of Contents 35 36 Preface 3 37 Introduction 4 38 1.0 Scope 4 39 2.0 Definitions 5 40 2.1 Correction 5 41 2.2 Corrective action 5 42 2.3 Data Sources 5 43 2.4 Concession 5 44 2.5 Preventive action 5 45 2.6 Nonconformity 5 46 2.7 Verification 6 47 2.8 Validation 6 48 3.0 Overview 6 49 4.0 Phase I: Planning 8 50 4.1 Planning for Measurement, Analysis and Improvement Processes 9 51 4.2 Establish Data Sources and Criteria 10 52 5.0 Phase II: Measurement and Analysis within and across Data Sources 11 53 5.1 Measurement 11 54 5.2 Analysis 11 55 6.0 Phase III: Improvement 14 56 6.1 Investigate 15 57 6.2