FDA 质量体系手册 第一章 质量体系法规.pdf

FDA FDA医疗器械质量体系手册 FFDDAA 本文翻译自：FDA医疗器械质量体系手册: 小实体（医疗器械企业）认证指南第一版 FDA网站上可查到原文 MedicalDeviceQualitySystemsManual 医疗器械质量体系手册 A Small Entity Compliance Guide First Edition (Supersedes the Medical Device Good ManufacturingPractices[GMP]Manual) 小实体企业认证指南第一版（用于取代原医疗器械GMP手册） Chapters 章节 Coverpage,Preface,Foreword 首页，前言 TableofContents 目录 1.TheQualitySystemRegulation 1. 质量体系法规 2.QualitySystems 2. 质量体系 3.DesignControls 3. 设计控制 4.ProcessValidation 4. 流程验证 5.PersonnelandTraining 5. 人员和培训 6.BuildingsandEnvironment 6. 建筑和环境 7.EquipmentandCalibration 7. 设备和校准 8.DeviceMasterRecord 8. 器械主记录 9.DocumentandChangeControl 9. 文档和变更控制 10.PurchasingandAcceptanceActivities 10. 采购和接收活动 11.Labeling 11. 标签 12.ProductEvaluation 12. 产品评价 13.Packaging 13. 包装 14.Storage,DistributionandInstallation 14. 存储，分发和安装 15.Complaints 15. 投诉 16.Servicing 16. 售后服务 17.QualitySystemsAudits 17. 质量体系审计 18.FactoryInspections 18. 工厂检查 19.Appendices 19. 附件 Coverpage,Preface,Foreword HHSPublicationFDA97-4179 首页，前言 MEDICALDEVICEQUALITYSYSTEMSMANUAL: A SMALLENTITYCOMPLIANCEGUIDE FirstEdition (SupersedestheMedicalDeviceGoodManufacturingPracticesManual) AndrewLowery,JudyStrojny,andJosephPuleo DivisionofSmallManufacturersAssistance OfficeofHealthandIndustryPrograms CENTERFOR DEVICESAND RADIOLOGICALHEALTH CDRH December1996 (ThispublicationsupersedesFDA91-4179) U.S.DEPARTMENTOFHEALTHANDHUMANSERVICES PublicHealthService FoodandDrugAdministration CenterforDevicesandRadiologicalHealth Rockville,Maryland20850 FOREWORD 前言 The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA), develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices, to control unnecessary human exposure to potentially hazardous