FDA 质量体系手册 第一章 质量体系法规

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1、FDA医疗器械质量体系手册本文翻译自：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ASmallEntityComplianceGuideFirstEdition(SupersedestheMedicalDeviceGoodManufacturingPractices[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Tab

2、leofContents目录1.TheQualitySystemRegulation1.质量体系法规2.QualitySystems2.质量体系3.DesignControls3.设计控制4.ProcessValidation4.流程验证5.PersonnelandTraining5.人员和培训6.BuildingsandEnvironment6.建筑和环境7.EquipmentandCalibration7.设备和校准8.DeviceMasterRecord8.器械主记录9.DocumentandChangeControl9.文档和变更控制10.Purc

3、hasingandAcceptanceActivities10.采购和接收活动11.Labeling11.标签12.ProductEvaluation12.产品评价13.Packaging13.包装14.Storage,DistributionandInstallation14.存储，分发和安装15.Complaints15.投诉16.Servicing16.售后服务17.QualitySystemsAudits17.质量体系审计18.FactoryInspections18.工厂检查19.Appendices19.附件Coverpage,Preface,

4、ForewordHHSPublicationFDA97-4179首页，前言MEDICALDEVICEQUALITYSYSTEMSMANUAL:ASMALLENTITYCOMPLIANCEGUIDEFirstEdition(SupersedestheMedicalDeviceGoodManufacturingPracticesManual)AndrewLowery,JudyStrojny,andJosephPuleoDivisionofSmallManufacturersAssistanceOfficeofHealthandIndustryProgramsC

5、ENTERFORDEVICESANDRADIOLOGICALHEALTHCDRHDecember1996(ThispublicationsupersedesFDA91-4179)U.S.DEPARTMENTOFHEALTHANDHUMANSERVICESPublicHealthServiceFoodandDrugAdministrationCenterforDevicesandRadiologicalHealthRockville,Maryland20850FOREWORD前言TheCenterforDevicesandRadiologicalHealth

6、(CDRH)oftheFoodandDrugAdministration(FDA),developsandimplementsnationalprogramstoprotectthepublichealthinthefieldsofmedicaldevicesandradiologicalhealth.Theseprogramsareintendedtoassurethesafety,effectiveness,andproperlabelingofmedicaldevices,tocontrolunnecessaryhumanexposuretopote

7、ntiallyhazardousionizingandnon-ionizingradiation,andtoassurethesafe,efficacioususeofsuchradiation.FDA器械及放射卫生中心（CDRH）开发并实施医疗器械及放射卫生领域旨在保护公共健康的国家项目。这些项目是为了确保医疗器械的安全，有效和正确标志，控制人体暴露于潜在的电离或非电离放射性危害，以及确保安全有效地使用此类辐射。TheCenterpublishestheresultsofitsworkinscientificjournalsandinitsowntech

8、nicalreports.Thesereportsdissemin