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1、GHTF/SG3/N18:2010FINALDOCUMENTGlobalHarmonizationTaskForceTitle:Qualitymanagementsystem–MedicalDevices–GuidanceoncorrectiveactionandpreventiveactionandrelatedQMSprocessesAuthoringGroup:StudyGroup3Date:4November2010Dr.LarryKelly,GHTFChairThedocumenthereinwasproducedbytheGlobalHarmonizationTask
2、Force,whichiscomprisedofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.Therearenorestrictionsonthereproduction,distribution
3、oruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.Copyright?2010bytheGlobalHarmonizationTaskForceGuidanceoncorrectiveactiona
4、ndpreventiveactionandrelatedQMSprocessesGHTF/SG3/N18:2010TableofContentsPreface........................................................................................................................................................................3Introduction.................................
5、................................................................................................................................31.0Scope............................................................................................................................................................
6、...42.0Definitions.......................................................................................................................................................42.1Correction..............................................................................................................
7、...........................42.2Correctiveaction...............................................................................................................................42.3DataSources.....................................................
