-内审管理用表单检查表-质量制度表格

'Orderno.:70198205201Date:Nov.4,2002Page1of55ModularAuditQuestionnaireTOVMANAGEMENTSERVICEPRODUCTSERVICEApplicant:ZhejiangAnjiSunlightMedicinalProductsCo.,Ltd.SunLightIndustry,AnjiCounty,ZhejiangProvince,P.R.China313300Auditedcompany:ZhejiangAnjiSunlightMedicinalProductsCo.,Lltd.SunLightIndustry,AnjiCounty,ZhejiangProvince,P.R.China313300Companyrepresent.:Mr.HeqingDongLeadauditor:Mr.XinggangXuTechnologyauditor(s):Mr.LiubaoLi,Mr.JerryJiaAuditrequirements:ISO9002:1994,EN46002:1996EC-Directive93/42/EECAnnexV.3TypeofAudit:CertificationAuditProducts,Category:MedicalBandageQ-Manual(number,dateofissue:Otherdocuments:Date(s)ofQ-documentinspection:Auditperiod:Nov.8,2002・Nov.9,2002 Comments: Orderno.:70198205201Date:Nov.4,2002Page3of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEScopeofthequestionnaireThisquestionnaireisbasedonthestandardsmentionedbelow・TheAudit-Questionnairecontainsquestionsfromthefollowingareas:•ISO9001•EN46001/ISO13485•MDD/AIMD/IVDDFile:CRT_F_07.33E/Rev.1/23.11.99File:CRT_F_15.30E/Rev.3/1.9.00File:CRT_F_15.31E/Rev.4/2002-04-01TableofcontentsGeneral4ECDirectives54.1:Managementresponsibility174.2:QualitySystem194.3:Contractreview204.4:Designcontrol214.5:Documentanddatacontrol254.6:Purchasing274.7:Controlofcustomer-suppliedproduct294.8:Productidentificationandtraceability304.9:Processcontrol324.10:Inspectionandtesting364.11:Controlofinspection,measuringandtestequipment404.12:Inspectionandteststatus424.13:Controlofnonconformingproduct434.14:Correctiveandpreventiveaction454.15:Handling,storage,packaging,preservationanddelivery484.16:Controlofqualityrecords504.17:Internalqualityaudits514.18:Training534.19:Servicing544.20:Statisticaltechniques55 Orderno.:70198205201Date:Nov.4,2002Page4of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234567GeneralISO9001Isthefollowingcompanyinformationup-to-date?E.g.•Address•Phone•Fax•E-mail•internethomepage•contactperson•productrangeNumberofemployees?•Completecompany•subsidiariesAddress,numberofemployeesExistingcertificates(productandQA)undersurveillance(certificate#,Scope)?Certificatesup-to-date?Significantchangessincethelastaudit?e.g.•Organization•QA-System•Processes•ProductsCorrectiveactionimplementedsincelastaudit?Advertisingwithcertification?•QA-system-certification•inrelationtoproductNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page5of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12345678ECDirectivesMDD/AIMD/IVDDClassification,ConformityAssessmentRoutes,DeclarationofConformity,andCE-markingOnlyMDD:Alldevices/products/・groupsclassified?OnlyMDD:Classificationcorrect?(exampleswithrule?)OnlyIVDD:Typeofproduct?□AnnexIIListA(Which?)□AnnexIIListB(Which?)□Homeuse?□BloodGlucose(ListB)□Othersforhomeuse(Which?)□Others(Which?)Selectedconformityassessmentroutesuitable?Allproducts/productgroupscovered?Declarationsforallproducts/devicesavailable?Doesdeclarationcoveragivennumberofproducts(AnnexII.3.2,V.2)ORstartofCE-marking(lot,date)?DeclarationofConformitycomplete(e.g.accordingtoEN45014)?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page6of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S91011121314151617CEmarkingaccordingtoarticle17andannexXIIofMDD/article12andannex9ofAIMD/article16andannex10orIVDD?Whereapplicable:ProcedureforputtingtogethersystemsandprocedurepacksandlabelingaccordingtoMDDarticle12?ControlledlistofallCEmarkeddevices?Guidanceonly:Listincludesclassification,rule,andifapplicableOEM-Manufacturer?SystemtoregularlyinformNotifiedBodyaboutCEmarkeddevices(definitionofsuitabletimeperiods)?InclusionofOEMproductsinconformityassessmentprocedure?ProcedureforinformationofNotifiedBodyineventofOEMsupplierchange?ControlledlistofOEM-suppliersavailable?Procedureforcontentofcontract/qualityagreementwithsupplierconcerninge.g.・Complaintsresponsibilities・Marketingsurveillance・Informationaboutchanges・TechnicalDocumentation・CertificationstatusNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page7of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1819TechnicalDocumentationProceduresandresponsibilitiesfordevelopmentandmaintenanceofthetechnicaldocumentation/file,thedesigndossier,thedocumentationfortypeexamination?OnlyMDD:AdequatetechnicaldocumentationinaccordaneewithAnnexVIIclause3orAnnexIIclause3.2coftheMDDNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page8of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S20OnlyIVDD:AdequatetechnicaldocumentationinaccordaneewithAnnexIIIclause3orAnnexIVclause3.2cExamplesforcheckofcompleteness?TechnicalDocumentationcontains□generaldescriptionoftheproductincludingintendeduse(MDD/IVDD)□listofaccessories,adaptors,intendeddevicecombinations(MDD)□possiblevariants(MDD/IVDD)□deviceclassification(MDD)□labeling,iinstructionsforuse,safetyinspections(sicherheitstechnischeKontrollen)(MDD/IVDD)□(harmonized)standardsused(MDD/IVDD)□resultsofriskanalysis(EN1441,ISO14971)(MDD/IVDD)□fulfillmentoftheEssentialRequirements(E.R.checklist)(MDD/IVDD)□clinicaldata(MDD)□performaneeevaluationdataacc・toAnnexVIII(incLrefereneemethod)EN13612(IVDD)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page9of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S□designdocumentationincludingdeviceperformsneespecifications,manufacturingmethods,instrumentdrawings/diagrams(MDD/IVDD)□resultsofdesigncalculationsandinspectionscarriedout(MDD/IVDD)□testreports(MDD/IVDD)□resultsofstabilitystudies(MDD/IVDD)EN13460used(IVDD)?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page10of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S212223ifapplicable:□originandcollectioninformationonmaterialsofhumanorigin(IVDD)□originandcollectioninformationonmaterialsofanimalorigin(MDD)□evidencethatessentialrequirementsarefulfilledifconnectedtootherdeviceswithintheintendeduse(MDD/IVDD)□testresultsforthecombinationwithmedicinalsubstancesifsuchsubstancesformanintegralpartofthedevice(classIIIMDD)□proofofsuccessfullycompletedconsultationprocess(MDD)□sterilisationmethodincludingvalidation(MDD/IVDD)□documentationofchanges(MDD/IVDD)□certificatesanddecisionsofNotifiedBody(MDD/IVDD)Forremarksraisedintechnicalreports(TypeExamination，DesignDossier,Others):Havecorrectiveactionsbeenimplementedandaretheyeffective?IfTechnicalDocumentationiskeptbythirdparty:accessandavailabilityofdocumentationcontractuallyagreedNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page11of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S2425262728CompliancewithEssentialRequirementsEvideneeofcomplyingwithEssentialRequirementsforeveryproduct(device)/productgroup(completeness)?Adoptedsolutionssuitable:(examples)•eliminate/reducerisks•takeadequateprotectionmeasurestorisks•informusersofresidualrisksduetoshortcomingsofprotectionmeasuresComplianceshownbyuseof•(harmonized)standards•CommonTechnicalSpecificationsRiskanalysisProcedureforcontentandresponsibilitiesforperformaneeoftheriskanalysis?□EN1441and/or□ISO14971considered?Procedureforreassessmentofrisks-incaseofproduct/manufacturingchanges•basedonresultsofmarket!ngsurveillance-asaresultofinformationaboutnewrisks?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page12of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S293031323334353637Chosenmeasuressuitable(giveexamples)?ClinicalInvestigationClinicalInvestigationsaccordingtoAnnexXclause2ofMDD(samplingfornonclassIIIproducts)IfnoClinicalInvestigationsrequired:Compilationofclinicaldata?Assessmentofavailablemarketdata?Areclinicaldataspecificfortheproducttheyareappliedto?Assessment/conclusionperformedbyqualifiedexpert?Datedandsignedsummaryreportavailable?Reportincludesconelusionthat,whenusedundertheconditionsandforthepurposesintendedbymanufacturertheperformaneeofthedevicecomplywithAnnex1.3MDDorAnnex1.2AIMD?Reportineludesconclusionthatundesirablesideeffectsundernormalconditionsofuseareacceptablewhenweighedagainstbenefitstothepatient?Clinicalaspectsconsideredinupdatedriskanalysis?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page13of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S3839404142434445Performance(IVDD)PerformaneeEvaluationsaccordingto•AnnexVIIIandAnnexLAofIVDD•prEN13612?Performaneedataspecificforrelevantproduct?CTSconsideredforlistAdevicesSuitablerefereneemethodselected(CE-marked?)Interferrjngsubstancesinvestigated-which?Serum/Plasmasamplesinvestigated?InformationaboutperformaneechangestopathogensandmarkersofinfectionstobetestedtoNotifiedBody?Incaseofself-testingdevices:Isselectedtrialgrouprepresentativeforthecommonuser?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page14of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S46474849LabelingandaccompanyingdocumentsLabelingandaccompanyingdocumentsaccordingto□Annex1.13MDD/□Annex1.14AIMD/□AnnexI.B8IVDD□(Harmonized)standards□EN375(IVDD)□EN376(IVDD-self-testing)□EN591/2(IVDDinstruments)□EN1658□EN980□EN1041□Productspecificstandards(which)□Others.Which?Procedurefortranslationofaccompanyingdocumentsandinformationincl.labelingintodestinationIanguages,retentionofcopiesCopiesoflabeling(devicelabelsetc.)retainedaspartofthetechnicaldocumentationSterilization(seealso4.9)Ifsubcontracted,isthesubcontractedsterilizationcompanycertifiedaccordingtoEN55XorhasowncertificateaccordingtoMDDforsterileproducts?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page15of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S5051525354555657PostMarketingSurveillanceandVigilancesystemDefinedprocedureandresponsibilityforgainingandreviewingexperieneeinthepostproduct!onphase(RecommendationNB-MED/2.12)?DefinedresponsibilitiesforincidentreportingaccordingtoArticle10oftheMDD/Article8ofAIMD/Article11oftheIVDD(jobdescription/training)?NotificationofincidentstonationalcompetentauthorityaccordingtoMDD/AIMD/IVDDandMED.DEV3/93)?Examplesavailable?InformationaboutvigilancereportstoTUVProductService?EuropeanRepresentative/ImporterEstablishedintheEuropeanCommunity?ExplicitlydesignatedbymanufacturertoactandbeaddressedbyauthoritiesandbodiesintheEuropeanCommunity(IVDDArt.21)?AvailabilityofTechnicalDocumentationatEuropeanRepresentative/Importer?OthersPre-lnformationaboutsubstantialproduct/technologyorQM-SystemChangestoNotifiedBody?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page16of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S58596061ResponsiblepersonsAreproceduresandresponsibilitiesfortheimplementationoftheprovisionsofnationallegislationdefined?Registrationofpersonsresponsiblefor„placingdevicesonthemarket1"(MDDArt.14,1/IVDDArt.10.1)performed?(formanufacturerorpersonplacedonanequalfootinginsideGermany):IsaresponsiblepersonnamedforthesafetyofmedicalproductsaccordingtoMPG§31?(insideGermanyifapplicable:):MedicaldeviceconsultantsaccordingtoMPG§32(education,training)?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page17of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.1:ManagementresponsibilityISO9001Fundamentaldeclarationofmanagement•relevanttoorganizationalgoals•relevanttocustomersexpectations•commitmentforqualityGoals•writtenpolicies•controlofresults•verifiableQualitypolicy•understood•implemented•maintainedOrganization•complete(organizationalchart)•refereneetoresponsibilitiesResponsibilitiesandpersonneltomaintainquality•staffneeds•resourcesallocatedManagementrepresentative•competenee•memberofmanagement•positionintheorganization•improvementsandcorrectionsbykeepingmanagementinformedNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page18of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S7891011QS-systemevaluationthroughmanagement•fixedtimeperiods•controlofresults•definedevaluationbasis,e.g.-auditreports-qualityreports-complaintreports•documentation•definitionofcorrectiveactionsMDD/AIMD/IVDDQualityobjectivesestablished?Organizationalstructureswithdefinedresponsibilitiesandauthoritiesfordesignandmanufactureofdevices?VerificationofeffectivenessofQS-SystemaccordingtoMDD/AIMD/IVDDconcerninge.g.•achievethedesiredqualityofdesignandofproduct•qualityofdesigndossier(MDDAnnexII.4/IVDDAnnexIV.4),DesignReviews•reviewofproductqualityandcontrolloopwithclinical/postmarketdata,riskanalysis,correctiveandpreventiveaction•controlofnon-conformingproductsRegulatoryAffairsreportsNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page19of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234.2:QualitySystemISO9001Systemdocumentation•structureofQ-systemdescribed•structureofdocumentationdescribed•allrelevantQ-elementsdescribed•enactedbyexecutivemanagement•tableofcontents,revision•refereneetoadditionalvaliddocuments•scopeandvalidity(organizational,productrelated...)•qualityplanningEN46001/ISO13485Individualrequirements•design•formulation•specifications•completemanufacturingprocess•qualityassurance/qualitycontrol•labeling•(ISO13485)Installationandservicing,ifappropriatefiledforeverytype/modelofmedicaldeviceMDD/AIMD/IVDDSystematicdocumentationwithstrategiesandwrittenprocedures?(programs,plans,manualsandqualityrecords)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page20of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.3:ContractreviewISO9001Procedures,responsibilities•offers•quotes•contractsCoordinationoftheparticipatingorganizationalunits,interfacewithcustomerCriteriaofcontractreview,e.g.•requirementsdefined•feasibility•personnel(productrequirements,installations,personnel,suppliedparts,qualitytests,qualifications,specifications,shippingrequirements,standards)Documentationofcontractreview•involvedorganizationalunits•customerresponseCorrelationbetweentenderandpurchaseorderverifiedContractchanges•procedures•responsibilities•documentationNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page21of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.4:DesigncontrolISO9001Procedures,responsibilitiesDesign-anddevelopmentplanning•designplanning•completeness•responsibilities•qualifiedpersonnel•adequateresources•updateofplansOrganizationalandtechnicalinterfaces•specification•documentation•verificationDesigninput•productrelatedrequirementsincl.legalandauthorityrequirements•verificationofcompleteness,clarityofdesign,absenceofcontradictions•useofresultsfromcontractreviewDesignoutput•documentation•acceptaneecriteria•characteristicse.g.safety,functionality(usage,storage,handling,repair,disposal)•verificationofresultsbeforereleaseDesignapproval•formalverificationofdesignresultsatappropriatemilestones•participants,incl.otherspecialists•documentationNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page22of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S789101112Designverification•verificationatappropriateintervalsifdesignresultsmeetrequirements，e.g.・alternativecalculations・comparisonwithproveddesign・qualifications,tests•inspectionofdesigndocumentspriortorelease•documentationDesignvalidation•verificationifproductmeetstherequirementsoftheuser•validationunderdefinedoperatingconditions•multiplevalidationsfordifferentfieldsofapplicationDesignchanges•identification•documentation•verificationEN46001/ISO13485Specificrequirementsconcerningsafetyidentifiedindesignspec.?Useof(harmonized)standards?Which?(ISO13485)Needfor(updateof)riskanalysisregularlyevaluated,recordskept?Allactivitiesfordesignverificationincludingclinicalevaluationidentifiedandimplemented?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page23of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S131415161718(ISO13485)Clinicalevaluationsperformedandrecordskeptaspartofdesignvalidation?MDD/AIMD/IVDDSeealso4.0EC-DirectiveTechnicaldocumentationTechniquesforsystematicmeasures,controlandverificationProceduresformonitoringandverifyingthedesignofthedevices:•devicedescription,variants•technicaldocumentationperMDD/AIMDAnnexIl3.2cIVDDAnnexIIIsection3•technicaldocumentationforselftestingperIVDDAnnexIII,section6.1•techniquesusedtocontrolandverifythedesign,andtheprocessesandsystematicmeasuresusedduringdesignIndependentevaluationofdesignanddevelopmentEvaluationandverificationofthedesignwith:•trainedpersonnel•applicablestandardsorin-housetestprocedures•representativeusersincaseofself・testingdevices(onlyIVDD)•adequateandcalibratedtestequipment?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page24of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S19202122TestinadequateinternallaboratoriesUseofexternaltestlaboratories(listofacceptedandapprovedtestlaboratories)EvaluationofcompeteneeofexternaltestlaboratoriesTestsduringdesignverification:□chemical,biological(biocompatibility)□medicinalsubstances(safety,quality,efficiency)□physicalproperties□hygienicproperties,sterility□constructionalsafety□environmentalsafety□mechanicalpropertiesandsafety□ergonomicfeatures□measuringfunction□compatibilitywithotherdevices(intendeduse)□EMC□radiation□electricalsafety□functionalsafety□protectionagainstthermalrisks□packaging(considerationofEN868ffforsterileMD)□softwaresafetyNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page25of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.5:DocumentanddatacontrolISO9001Procedures,responsibilitiesComprehensivewithrespectto•systemrelateddocuments(e.g.QA-Manual,SOP"s,workinstructions5forms)•technicaldocuments(e.g・drawings,schematics)•externaldocuments(e.g・customerdrawings)•highleveldocuments(e.g・standards,laws)Procedurecomprehensivewithrespectto•compilation•approval•release•labeling(alsoobsolete)•distribution•change•filingandstorageDocumentchangesbysameunitswhichissuedoriginaldocumentMarkingofobsoletedocumentsorappropriatesurveillanee,handlingofobsoletedocumentsMarkingofchangesNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page26of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S7891011EN46001/ISO13485Markingondocuments(includingelectronically):•lastrevisionwithkindofchange•creator•date•identificationArchivingofdocumentsanddataregulatedApprovalandauthorizationofchangesRetentionofunvalidproductspecs・MDD/AIMD/IVDDRetentionperiodofdocumentsaccordingMDDAnnexII,6.1(AnnexV,5.1);IVDDArticle9.7e.g.•declarationofconformity•documentationofthequalitysystem•decisionsoftheNotifiedBody•DesignDossier/TechnicalDocumentation(5yearsafterlastproducthasbeenmanufactured)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page27of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12345674.6:PurchasingISO9001Purchasing,selectionofsuppliers(selectionforfirstsamples)procedures,responsibilitiesProcedurecomprehensiveforsuppliersofe.g.•components,subassemblies•rawmaterials•servicesSelectioncriteriaforsupplierse.g.•firstsampleinspections•system-process・and/orproductaudit•certifications•referencesPurchasing/supplierevaluation(continuousrating)procedures,responsibilitiesMethodsappropriateandeffectivee.g.•resultsofincominginspections•regularlyscheduledaudits•analysisofdeliverydelays•analysisofcustomercomplaintsDocumentationrecordsofhigh-qualitysuppliersNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page28of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S891011Purchasingdata•procedures,responsibilities•comprehensiveprocedureregardingrequirementsforpurchasedproducts(drawings，specifications,processrequirements,deliveryterms,accompanyingdocuments,approvals,applicablestandards)•testandverificationproceduresIfapplicable:proceduresforverificationbycustomeratthesupplierorsubcontractorEN46001/ISO13485RetentionofpurchasingdocumentsfortraceabilityMDD/AIMD/IVDDIVDD/MDD-requirements,responsibilitiesanddocumentationregulatedwithsupplier(contracts,qualityagreements)?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page29of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S124.7:Controlofcustomer-suppliedproductISO9001Procedures,responsibilitiesProceduresuitablewithrespectto•contract•receiving•labeling•handling/storage•maintenance/approval•loss/damage•nonconformities•informationofcustomerNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page30of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12345674.8:ProductidentificationandtraceabilityISO9001Procedures,responsibilitiesProceduresuitablewithrespectto•allphasesofproductdevelopment(fromincomingtodelivery)•productidentification•markingindocumentationIdentificationcodegiveninproductiondocumentsTraceabilityofproducts,procedures,responsibilitiesProcedurecontainse.g.•planningoftechnicalimplementation•planningandimplementationofthedocumentationEN46001/ISO13485Identification:•identificationofproductsforrefurbishing•separationfromnormalproductionTraceability:Degreeoftraceabilityforperformaneeof•correctiveactions•(ISO13485)preventiveactionsNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page31of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S8910Traceabilityforimplantableproducts:Traceabilityforallcomponents,materials,environmentalconditionsiflikelytocausenon-conformancies(ISO13485)Proceduretorequiretraceabilityatdistributororagent?Availabilityofdistributionrecordsforinspectionatdistributororagent?MDD/AIMD/IVDDInspectionandqualityassurancetechniques•productidentificationateverystageofmanufactureNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page32of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12345674.9:ProcesscontrolISO9001Procedures,responsibilitiesControlledprocessesin•production•assembly•servicing•subcontradedassembliesControlledproduct!onensuredbye.g.•productionplanning(technical,timeschedule)•releaseofworkinstructions•approvalofprocesses•surveillanceandcontrol•maintenanceofproductionequipment•qualifiedpersonnelCompleteness,e.g.•product!onsteps•procedures•manufacturingequipment,tools•processparameters•testingandinspect!onsteps•workmanship(referencesamples)CapabilityofprocessesandequipmentDocumentationofsingleworkstepsControlofmeasurementequipmentusedforprocesscontrolNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page33of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S891011Appropriateworkingconditionse.g.•cleanliness•lighting•temperature•workclothing""Specialprocesses41:•qualificationofpersonnel•qualificationofprocessesandequipment•continuouscontrolofprocessparameters•documentationEN46001/ISO13485(A)Requirementsfor•health•cleanliness(hygiene)•clothingofpersonneliflikelytocauseadverselyaffecttoproductquality(B)Requirementsonproductionenvironmentinthecase:•suppliedsterile•sterilizedpriortouse•microbiologicalstatusrelevantforfunctionandstabilityofproduct•specialconditionsforapplication(microbial/particulatecleanlinessetc.)•specialrequirementsforproduction•control/recordingofenvironmentalconditions(ifapplicable)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page34of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S—L—L—L98765432(C)Requirementsoncleanlinessofproductif•cleaningpriortosterilizationand/orapplication•nocleaningprocessbutcleanlinessimportant•removalofprocessagentsduringmanufacturingprocess(ifCisapplicable,AandBarenotrequired)(ISO13485)Proceduresforvalidationoftheapplicationofcomputersoftwareusedforprocesscontrol?(ISO13485)Recordsofsoftwarevalidationkept?Auditedexamples?Requirementsformaintenanceifinflueneeonproductquality?Ifapplicable:instructionsandacceptaneecriteriaforinstallationandcontrolofthemedicaldevicesRecordsaboutinstallationandcontrolretainedfromsupplierorauthorizedrepresentativeWritteninstructionsforinstallationandcontrolifinstallationbythirdpartyForspecialprocesses:Qualityrecordson•usedworkinstruct!on•dateofperformance•identityofoperatorNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page35of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S202122232425Forsterilemedicaldevices:•controlofrawmaterials•validationofpackagingprocess•validationofsterilizationprocess•recordofcontrolparameters•useofharmonizedstandards(EN550ff,EN867ff,EN868ff,EN1174ff)MDD/AIMD/IVDDInspectionandqualityassuraneetechniques•processesandprocedurestobeusedregardingcleanroommanufacturing•processesandprocedurestobeusedregardingsterilizationPartsofproductionexternal?•subcontracted?■proIongedworkbench?Requirementsforexternalproduct!ondefined?InformationofNotifiedBodyincaseofsubcontractingpartsofproduction?Auditatoutsideproductionnecessary?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page36of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12345674.10:InspectionandtestingISO9001Procedures,responsibilitiesProcedurescontain•inspectionplans/useofsupplierevaluation•receivinginspection/testing•in-processinspection/testing•markingofteststatus•refereneesamples•documentationofresultsInspect!ondocumentscompleteandappropriate•inspectedcharacteristics(scopeofinspectionandtesting)•testcharacteristics•acceptaneeandrejectioncriteria•inspection,measuringandtestequipment•documentationofresultsProceduresforearlyreleaseIn-ProcessinspectionandtestingProceduresandresponsibilitiesProcedurescontain•inspectionplans•inspection/testing•markingofteststatus•documentationofresultsNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page37of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2SOLc|COCO6LLLLInspectiondocumentscompleteandappropriate•inspectedcharacteristics(product!ondocuments)•standards•numbersoftests•testcharacteristics•acceptanee,rejectioncriteria•measurementequipment•documentationProceduresforsampling/samplingsize•takingasample•identification•submissiontotestlab•registrationFinalinspectionandtestingProcedures,responsibilitiesProcedurecontains•inspectionplanning•completenessofprevious•inspections•inspections•identificationofteststatus•documentationofresults(incl.personresponsibleforrelease)Inspectiondocumentscompleteandappropriate•product!ondocuments•standards•numbersoftests•testcharacteristics•acceptanee,rejectioncriteria•measurementequipment•documentationNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page38of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S141516171819EvidenceoftestingforcustomerEN46001/ISO13485Forimplantablemedicaldevices:RecordofidentityofinspectionandtestingpersonnelMDD/AIMD/IVDDTestsaccordingtoessentialrequirementsofAnnexIofMDD/AIMD/IVDDInspectionandqualityassuraneetechniques•processesandprocedurestobeusedregardingsterilization•purchasedmaterialsDefinitionofteststobeperformed•before,during,andaftermanufacture•frequencyoftests•testequipmentused(withtraceablecalibration)Controlsandtestsaccordingtothelateststateoftheart?•includesrawmaterialcharacterization?•ineludesindividualdevicesoreachbatchofdevicesmanufactored?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page39of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S20212223IntestingAnnexII,ListAdevices,doesmfrtakeintoaccounttheCTSandthemostrecentinformationregardingthebiologicalcomplexityandvariabilityofthespecimenstobetestedwiththedevice?Useofharmonizedstandards(AnnexV)DeliveryonlyifessentialrequirementsfulfilledInformationaboutusedtestequipmentintestrecordsNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page40of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S123454.11:Controlofinspection,measuringandtestequipmentISO9001Procedures,responsibilitiesProcedurescompletewithrespectto•measurementandtestequipment,software•specification/purchasing•registration•incominginspection•identificationandteststatus•handling•surveillanee•handlingoffaultymeasurementequipment•documentationRecordsformeasurementequipmentcontainse.g.•itemnumber•areaofapplication•specification/measuringrange•acceptablemeasurementerror•notesconcerningmeasuringandcalibrationinstruct!ons•calibrationscheduleCalibrationwithindefinedintervalswithcertifiedequipmentoraccordingtodocumen怕dstandardsEvaluationofvalidityofprevioustestswhentestequipmentisfoundtobefaulty?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page41of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S67Environmentalconditionsfor•calibrations•testsandmeasurementsHandlingofmeasurementandtestequipment•settingssecuredagainstchangesNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page42of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234.12:InspectionandteststatusISO9001Procedures,responsibilitiesProcedurescompletewithrespectto•receiving•production•finalinspectionandtesting•storagerequirements•earlyreleaseifapplicableProceduresuitablewithrespectto•identification,e.g.•inspectionstamps•tags•accompanyingdocuments•storageplaces•softwareNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page43of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.13:ControlofnoneonformingproductISO9001Procedures,responsibilitiesProcedurecomprehensiveconcerningallphasesofproductdevelopment(receivingtodisposition)Procedurecontains•notification•registration•classificationoffailures/failurecauses•identification/separatestorage•approvalconcerning-re-work-re-grading(foralternativeuses)-rejection・returntosubcontractor・exceptions/concessions•customerapproval•notificationofappropriatefunctionsRe-testing,re-inspectionafterrework/repairDocumentation•failure•decisions•positionofthecustomer•re-testingEN46001/ISO13485Acceptanceofnon・conformingproductonlyifregulatoryrequirementsfulfilledNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page44of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S789Identityofpersonauthorizingtheconcessionrecorded(ISO13485)Determinationofanyadverseeffectofreworkuponproductmadeanddocumentedpriortoapproval?Recordsavailable?Reworkonlywithapprovedworkinstructions?Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page45of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S123454.14:CorrectiveandpreventiveactionISO9001Procedures,responsibilitiesProcedurescompleteandappropriate•classificationofnoneonformities•investigationofnonconformitysourcesw.r.t.product,processes•determinationofactionswithresponsibilitiesandschedule•informingaffectedunits•surveillanceofactionsandtheireffectivenessProceduresappliedfor•customercomplaints•notificationonfailureswith-product・process・system•internalauditsPreventiveaction,procedures,responsibilitiesProcedurescompleteandappropriate•assessmentofpotentialfailurecausesw.r.t・product,processandsystem•determinationofmeasureswithresponsibilitiesandschedule•informationofresponsibleareas•surveillanceofmeasures•assessmentofeffectivenessNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page46of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2SOLCMCO9卜006llllProcedurecontainsassessmentofinformationfor•qualityrecords•customercomplaints•servicereports•concessions•qualityaudits•systematicassessmentof-workprocesses・FMEAs•deliveryofinformationsforQA-systemevaluationEN46001/ISO13485FeedbacksystemforearlywarningofqualityproblemsandstartofcorrectiveactionResponsiblepersonfor•postmarketsurveillanee•customercomplaints•inspectionofreturnedproductsSubmissiontorelevantbodies,regulatoryauthoritiesSystemforadvisorynotesandrecallsRecordsifcustomercomplaintnotfollowedbycorrectiveactionsMDD/AIMD/IVDDSeealso4.0EC-Directive:SurveillaneeandVigilancesystemVigilanceSystemNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page47of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S141516Systematicprocedureforasurveillaneesystemafterproduct!onProceduretoimplementnecessarycorrectiveactions?Proceduretonotifycompetentauthorities(andNotifiedBody)ofincidents(AnnexIII,section5)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page48of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S12344.15:Handling,storage,packaging,preservationanddeliveryISO9001Procedures,responsibilitiesHandling/storage•allstorageandproductionareas•receivingarea•responsibilitiesforstorageareas•storageregulations•identifiedstorageareas•controlofstorageareainappropriateintervals•productswithlimitedshelflifetime•regulationsfordamages•meansfortransportationandhandlingPackaging/conservation•definitionofmethodology•suitabilityofmethods•separationofproducts•considerationofcustomerrequirements•labelingofpackaging•completenessofaccompanyingdocumentsDelivery(untilthecontractuallyagreedexchangeofproducts)•definitionofdeliverymethods•recommendedtransportationconditions•commissioning•selectionofdeliveryserviceNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page49of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S567891011EN46001/ISO13485ControlofproductswithlimitedshelflifetimeorspecialstorageconditionsControlandrecordofspecialstorageconditionsSpecialproceduresforhandlingofusedproductstoavoidcontaminationForsterilemedicaldevices:Suitabilityofpackagingfor•maintainingsterility(exceptsterileinnersurfaceguaranteedbydesign)•asepticsupply(ifrequired)•detectionoflossofsterilityForimplantablemedicaldevices:IdentificationofpersonaffixingthefinallabelingRecordofnameandaddressofrecipientofshippingpackageRecordsofdistributionanddeliveryatauthorizedrepresentativeNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page50of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.16:ControlofqualityrecordsISO9001Procedures,responsibilitiesProcedurescompleteandappropriate•definitionofQ-records(internalandexternal)•identification•organization•writing•distribution•collection•storage(location,time)•maintenance•availability/releaseQualityrecordsuitable•demonstrationofeffectivenessofthequalitysystem•evideneeofproductquality•informationofareas•assessment(correctiveandpreventiveaction,qualitycostsetc.)EN46001/ISO13485Archivingofqualityrecordsaccordingtolifetimeofproductandatleast2yearsafterdelivery(ISO13485)Longerrecordretentionperiodrequiredbynationalorregionalregulations?Whichperiods?Compliance?ArchivingtoguaranteetraceabilityofthequantityproducedandreleasedperbatchNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page51of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S123456784.17:InternalqualityauditsISO9001Procedures,responsibilitiesProcedurescompleteandappropriate•auditplaning(regularscheduled,extraordinary)•preparation(checklists)•performing•documentation•definitionofmeasures•assessmentandverificationofeffectivenessProcedureadequatew.r.t.involvementofrelevantareasQualification/independenceofauditorsPreparationofchecklistsConsiderationofresultsfrompreviousauditsanddeficienciesDocumentationofaudits•nonconformancies/deviations•correctiveactions•responsibilities,deadline•informationofareasinvolved•informationofmanagementSurveillance•re-audits•verificationofeffectivenessofcorrectiveactionsNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page52of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S9MDD/AIMD/IVDDConsiderationofspecificrequirementsandaspectsofAnnexII,3(AnnexV,3)ofMDD/AIMD,AnnexIV.3(VII.3)ofIVDDNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page53of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S123454.1&TrainingISO9001Procedures,responsibilitiesProcedurescompleteandappropriate•regularevaluationoftrainingneeds•definitionoftrainingplans•training•documentationAppropriateprocedures•involvementofallemployees•qualificationprofileTrainingappropriatefor•firsttraining•jobspecifictraining•companyrelatedissues•specialqualification•qualityassuraneetrainingEN46001/ISO13485Trainingand/orsupervisionofpersonnelworkingunderspecialenvironmentalconditionsorperformingspecialprocessesNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page54of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S123454.19:ServicingISO9001Procedures,responsibilitiesProcedurescompleteandappropriate•informingcustomersregardingtheuseoftheproducts•equipmentandinformationsuppliedtocustomerservicerepresentatives•spareparts•feedbackfromthemarket•handlingofcustomercomplaintsDocumentationforcustomers,e.g.•productinformation/warnings•installationinstructions•usermanuals/instructions•maintenanceinstructions•sparepartslistEquipmentforcustomerservicerepresentatives•productinformation•tools•inspection,measurementandtestequipment•trainingEvaluationofcustomercomplaints•informationofareasconcerned•definitioncorrectiveandpreventiveactions•influenceofnewdesignNotes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded Orderno.:70198205201Date:Nov.4,2002Page55of55ModularAuditQuestionnaireTUVMANAGEMENTSERVICEPRODUCTSERVICEQA-Element:错误!使用“开始”选项卡将Heading1应用于要在此处显示的文字。No.QuestionsontheQ-SystemDocumentationoftheQ-SystemE*AuditNotesECE1SE2S1234564.20:StatisticaltechniquesISO9001EvaluationoftheneedProcedures,responsibilitiesEvaluationoftheneedforstatisticalproceduresforsurveillaneeandinspectionofprocesscapabilityandproductcharacteristicsStatisticalmethods,application，procedures,responsibilities•appropriateprocedurescomplete•preconditionforsampling•qualificationofpersonnel•useofstandards(e.g.DIN40080)•surveillanceoftheprocedures•documentationofresultsProceduresadequatefore.g.•design(FMEA,riskanalysis)•incominginspection•finaltesting•processcapability•assessmentofQ-recordsEN46001/ISO13485Regularreviewconcerningreportsofnorveonformingproducts,auditreports,customerfeedbacketc.(procedures?)Notes*Evaluation:0=notapplicable1=fulfilled2=partlyfulfilled,acceptable3=notfulfilledwhat-who・withwhat・where•when•howoften•whichdocuments/forms•whatisrecorded 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