MDSAP AU P0002.004 Audit Model

2MEDICALDEVICESINGLEAUDITPROGRAMAUDITMODEL2017-01-06MDSAPAUP0002.0042TableofContentsOverview...............................................................................................................5AuditSequence.....................................................................................................5ConductingtheAudit.........................................................................................8NavigatingtheAuditSequence...........................................................................…8Terminology.......................................................................................................….9ReferencetoAnnexes…………………………………………………………………………………..9AuditCycle............................................................................................................9InitialAudit........................................................................................................10Stage1..........................................................................................................10Stage2..........................................................................................................10SurveillanceAudits..........................................................................................11Re-audit..........................................................................................................12SpecialAudits..................................................................................................13UnannouncedAudits..........................................................................................14AuditsConductedbyRegulatoryAuthorities..................................................14Chapter1Process:Management..........................................................................15Chapter2Process:DeviceMarketingAuthorizationandFacilityRegistration......20Chapter3Process:Measurement,AnalysisandImprovement..................................23Chapter4Process:MedicalDeviceAdverseEventsandAdvisoryNoticesReporting..................................................................................32Chapter5Process:DesignandDevelopment.......................................................34Chapter6Process:ProductionandServiceControls...........................................42Chapter7Process:Purchasing...........................................................................553Annex1–AuditofTechnicalDocumentation……………………………………………………62Annex2–AuditofRequirementsforSterileMedicalDevices…………………………………72SummaryofChangesfromPriorRevision…………………………………………………………784ForewordTheMedicalDeviceSingleAuditProgram(MDSAP)isintendedtoallowcompetentauditorsfromMDSAPrecognizedAuditingOrganizations(AOs)toconductasingleauditofamedicaldevicemanufacturer’squalitymanagementsystemthatwillsatisfytherequirementsofthemedicaldeviceregulatoryauthoritiesparticipatingintheMDSAPprogram.AuditsperformedundertheMDSAPprogramwillbeprocessbased,focusingonseveraldefinedprocesses,adefinedmethodforlinkingthoseprocesses,andbuiltonafoundationofrequirementsforriskmanagement.UseofthisdocumentThisdocumentcontainsspecificinstructionsforperformingauditsundertheMDSAPprogram.Itincorporatesanauditsequenceandinstructionsforauditingeachspecificprocess.Thedocumentalsoprovideslinkstohighlighttheinteractionsbetweentheprocesses.Thedocumentadditionallyemphasizestheinterrelationshipstorelevantriskmanagementactivities.Linkstospecificprocessesarenotedina“red”boxifviewingacolorversionofthedocument,orareingrayboxesifviewingtheblackandwhiteversion.Theinterrelationshipsofriskmanagementarealsonotedinthedocumentandthosearein“blue”andthisfont.TheMDSAPAuditProcessCompaniondocumentisalsoavailable.Thatdocumentisprovidedasareferenceandincludesadditionaldetailregardingeachauditedprocessaswellasguidanceforassessingtheconformityofeachprocess.Pleaserefertothecompaniondocumentasneeded.5MedicalDeviceSingleAuditProgramOverview:TheMedicalDeviceSingleAuditProgram(MDSAP)auditprocesswasdesignedanddevelopedtoensureasingleauditwillprovideefficientyetthoroughcoverageoftherequirementsofMedicaldevices–Qualitymanagementsystems–Requirementsforregulatorypurposes(ISO13485:2016),theQualityManagementSystemrequirementsoftheConformityAssessmentProceduresoftheAustralianTherapeuticGoods(MedicalDevices)Regulations(TG(MD)RSch3),BrazilianGoodManufacturingPractices(RDCANVISA16/2013),JapanOrdinanceonStandardsforManufacturingControlandQualityControlofMedicalDevicesandInVitroDiagnosticReagents(MHLWMinisterialOrdinanceNo.169),theQualitySystemRegulation(21CFRPart820),andspecificrequirementsofmedicaldeviceregulatoryauthoritiesparticipatingintheMDSAPprogram.AuditSequence:TheMDSAPauditsequencewasdesignedanddevelopedtoallowfortheaudittobeconductedinalogical,focused,andefficientmanner.TheMDSAPauditsequencefollowsaprocessapproachandhasfourprimaryprocesses:(1)Management;(2)Measurement,AnalysisandImprovement;(3)DesignandDevelopment;(4)ProductionandServiceControls;andasupportingprocess,(5)Purchasing.Thedefinitionofeachprocessincludesapurpos