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Guidance on corrective action and preventive action and related QMS processes

Guidance on corrective action and preventive action and related QMS processes

ID：40080595

大小：318.64 KB

页数：26页

时间：2019-07-20

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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.....................................................

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