GHTF-SG3-N15R8-2005 Implementation of risk management principles and activities within a Quality Management System

《GHTF-SG3-N15R8-2005 Implementation of risk management principles and activities within a Quality Management System》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、GHTF/SG3/N15R8FINALDOCUMENTTitle:ImplementationofriskmanagementprinciplesandactivitieswithinaQualityManagementSystemAuthoringGroup:GHTFStudyGroup3Endorsedby:TheGlobalHarmonizationTaskForceDate:May20,2005AbraaoCarvalho,GHTFChairThisdocumentwasproducedbytheGloba

2、lHarmonizationTaskForce,avoluntaryinternationalgroupofrepresentativesfrommedicaldeviceregulatoryauthoritiesandtradeassociationsfromEurope,theUnitedStatesofAmerica(USA),Canada,JapanandAustralia.Thedocumentisintendedtoprovidenon-bindingguidancetoregulatoryauthor

3、itiesforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslation

4、intolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.Copyright©2000bytheGlobalHarmonizationTaskForceGHTFStudyGroup3SG3/N15R8Page2of23IMPLEMENTATIONOFRISKMANAGEMENTPRINCIPLESANDACTIVITIESWITHINAQUALITYMAN

5、AGEMENTSYSTEM1.Introduction1.1.Purpose1.2.Scope2.Definitions3.General3.1.Documentation3.2.Communication4.ManagementResponsibilities5.Outsourcing6.Planning7.DesignandDevelopment7.1.Designanddevelopmentplanning7.2.Designanddevelopmentinput7.3.Designanddevelopmen

6、toutputs7.4.Designanddevelopmentreview7.5.Designanddevelopmentverification7.6.Designanddevelopmentvalidation7.7.Controlofdesignanddevelopmentchanges7.8.Designanddevelopmenttransfer8.Traceability9.PurchasingControlsandAcceptanceActivities9.1PurchasingControls9.

7、2AcceptanceActivities10.ProductionandProcessControls10.1.Manufacturing,MeasuringandMonitoringEquipment10.2.WorkEnvironmentandPersonnel10.3.ProcessValidation11.Servicing12.AnalysisofData13.CorrectiveandPreventiveActions(CAPA)Annexes:AnnexA–AnExampleofaRiskChart

8、forCommunicatingInternalRiskManagementActivitiesRiskManagementGuidanceGHTFStudyGroup3SG3/N15R8Page3of23AnnexB–FlowChart–RiskManagementActivitiesinDesignandDevelopmentAnnexC–Example