ISO 13485_2008-05-25

ISO13485 2003 AManufacturer sPerspectiveWhatdoyouneedtodotocomply Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide2 Objectives Followingthisworkshop participantswill AccuratelyandeffectivelyusetheknowledgegainedfromthisworkshoptoensurecompliancewithISO13485 2003 ApplyafunctionalknowledgeofthisimportantinternationalstandardtodevelopindividualandorganizationalcompetenciessupportingQualityManagementSystems EffectivelylearnhowtouseISO13485tofacilitateyourorganization scompliancewithglobalregulatoryrequirements BuildingBlocksforSuccess TheServicesULOffersforMedicalDeviceCompanies Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide4 ServingUL sCustomersWith CEMarkingthroughNotifiedBody ULUK FDA510 k Third PartyReviewQualityManagementSystemRegistrationProductSafetyandEMCCertificationGlobalMarketAccessCustomerTraining ConsultingServices Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide5 WhydoesULdeliverCustomerTraining BringstogetherthetremendousintellectualcapitalthatexistsinallareasacrossULCombinesanunderstandingofourcustomers businessissues andultimatelyappliesUL stechnicalexpertisetothoseissuesWeworkwithourcustomerstofacilitatetheconstructionofaneffectiveandfunctionalQualitySystem Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide6 Announcements ScheduleFacilitiesClassIntroductionName backgroundGoalforclassExpectationsAgenda Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide7 TheWorkshop What sourcourselooklike IntroductionandIcebreakerGlobalMedicalRegulatoryRequirementsTheScopeandNormativeReferences Modules1 2 TermsandDefinitions Module3 QualityManagementSystem Module4 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide8 TheWorkshop continued ManagementResponsibility Module5 ResourceManagement Module6 ProductRealization Module7 Measurement Analysis andImprovement Module8 Post classAssessment Summary Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide9 Questions ISO13485 2003 IntroductiontotheStandardPreassessment Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide11 Pre assessment Whywasaseparatequalitysystemstandardpublishedforthemedicaldeviceindustry List4keyprocessesinyourorganization Whatissuppliermanagement andwhyisitimportant Whatisriskmanagement andwhyisitimportant Whoshouldbeinvolvedintheplanningofproductrealization Whyisitimportanttocontroldesignchanges Whatproductionprocesseshaveanoutputwhichcouldnotbeverifiedbymonitoringormeasurement Whatisprocessvalidation Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide12 GoalofISO13485 AchieveCustomerSatisfactionCompliancewithregulatoryrequirementsFacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide13 GlobalRegulatoryStructure FDA Canadian Europeanapproaches Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide14 GlobalRegulatoryStructure Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide15 OverviewOfUSMedicalDeviceComplianceScheme TosellamedicaldeviceintheUS manufacturer smustmeettheFDAregulatoryrequirementsasdefinedintheCodeofFederalRegulations21CFR800 1299ThegoaloftheregulationsistoensurethedevicesdistributedintheUSarebothsafeandeffectiveRegulatorysystemhas3maincomponentsPre marketlicensingPostmarketsurveillanceQualitySystemRequirements QSR Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide16 OverviewOfUSMedicalDeviceComplianceScheme 21CFRPart820CoverstheQualitySystemRegulations QSR QSRcloselymatchesISO13485TheFDAisresponsibleforassessingtheconformityofamedicaldevicemanufacturer squalitysystemtotheQSRrequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide17 Canada sMedicalDeviceComplianceScheme TosellamedicaldeviceinCanada manufacturer smustmeettheregulatoryrequirementsasdefinedinthe MedicalDevicesRegulation MDR ThegoaloftheregulationsistoensurethedevicesdistributedinCanadaarebothsafeandeffectiveRegulatorysystemhas3maincomponentsPre marketlicensingPostmarketsurveillanceQualitySystemRequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide18 Canada sMedicalDeviceComplianceScheme Thequalitysystemrequirementsareknownas CanadianMedicalDeviceConformityAssessmentSystem CMDCAS ManufacturersofClassIIdevicesmustsatisfythequalitysystemrequirementofISO13488ManufacturersofClassIIIandIVdevicesmustsatisfythequalitysystemrequirementofISO13485 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide19 EuropeanMedicalDeviceDirectives Medicinalproducts 65 65 EEC ActiveImplantableDevices 90 385 EEC MedicalDevices 93 42 EEC InVitroDiagnosticMedicalDevices 98 79 EC IVDD Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide20 EuropeanMedicalDeviceDirectives Inalmostallcases themanufacturermustensurethatthemanufacturingprocessfollowstheprinciplesofqualityassuranceassetoutintheapplicablecomplianceAnnexComplyingwithEN ISO13485givesapresumptionofconformancewiththeserequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide21 AsiaPacificMedicalComplianceScheme RegulatorsinAustralia Japan China Taiwan Singapore ThailandeitherformallyrequireproofofcompliancewithISO13485 8orinformallyexpectcomplianceaspartoftheimportpermitprocess Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide22 ISO13485 QualitySystemManagementisrequiredbyallmajormarkets aunifyingregulatorythemeISO13485isuniversallyacceptedasthestandardtouseformedicalqualitysystemmanagementrequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide23 Module1 Clauses1 1 General 1 2 Application DifferencesfromISO9001Scope EmphasisonthemedicalfieldandcompliancewithregulatoryrequirementsTerminologyISO9001TerminologyISO13485TerminologycontinuallyimprovemaintainitseffectivenessCustomersatisfaction Removed ObjectiveApplication exclusions Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide24 Module2 NormativeReferences ISO9000 2000 QualityManagementSystems Fundamentalsandvocabulary Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide25 Questions ISO13485 Module3 Terms Definitions Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide27 Terminology Accreditation procedurebywhichanauthoritativebodyextendsformalrecognition thatapersonorbody organization iscompetenttosuccessfullyexecutespecifictasks sub clause13 7 ISO IECGuide2 AdvisoryNotice noticeissuedbytheorganization afterdelivery toprovidesupplementaryinformationand ortoadvisewhatactionshouldbetaken use modification return destruction Assessment theevaluationofacompany squalitymanagementsystemagainstaStandard scriteriainordertoevaluatethecompany slevelofcompliance Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide28 Terminology Certification aprocedurebywhicha ThirdParty provideswrittenassurancethataproductorserviceconformstothespecifiedrequirementsofaStandardCertificateofConformity arecordthatisissuedasobjectiveevidencethataproductorserviceconformstotherequirementsofaStandardCompliance indicatingorjudgingthataproductorservicemeetsspecifiedrequirementsCorrectiveAction actiontakentoeliminatethecausesofanexistingnonconformity defectorotherundesirablesituationinordertopreventrecurrence Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide29 Terminology CustomerCompliant Communication written electronic oral thatallegesdeficienciesrelatedtotheidentity quality durability reliability safetyorperformanceofamedicaldevicethathasbeenplacedonthemarketISO theInternationalOrganizationforStandardization ISOtakenfromtheGreekword isos meaning equal orindicating equivalency Labeling written printedorgraphicmatteraffixedtoamedicaldevice containerorwrapperoraccompanyingamedicaldevice thatisrelatedtoidentification technicaldescriptionanduseofthemedicaldevice Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide30 Terminology Non conformity aprocessthatdoesnotconformtoaqualitysystemrequirement Inqualitycircles thewordistypicallysynonymouswith citation deficiency discrepancy finding infraction non compliance orviolation Objectiveevidence informationwhichcanbeprovedtrue basedonfactsobtainedthroughobservation measurement testorothermeansObservation afindingoffactintheauditprocessthatissubstantiatedbyevidenceProcedure specifiedwaytoperformanactivityProcess any operation inbusiness Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide31 Terminology Medicaldevice instrument apparatus implement machine appliance implant invitroreagentorcalibrator software materialorothersimilarorrelatedarticle intendedbythemanufacturertobeused Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide32 Terminology Quality thetotalityorsumofanentity sfeaturesandcharacteristics thatindicateitsabilitytosatisfyastatedorimpliedneedQualityplanning activitiesthatestablishtheobjectivesandrequirementsforquality andfortheapplicationofqualitysystemelements coversproductplanning managerialandoperationalplanning includingestablishingtheobjectives requirementsforquality constraints organizingandschedulingQualitySystems theorganizationalstructure responsibilities processes andresourcesneededtoimplementQualityManagement Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide33 Terminology Record documentwhichfurnishesobjectiveevidenceofactivitiesperformedorresultsachievedRegistration aprocedurebywhichabodyindicatesthatrelevantcharacteristicsofaproduct process serviceorparticularsofabodyorperson arepubliclylistedRegistrationBody thisbodyconductstheregistrationorcertificationofconformity aka RegistrarSterilemedicaldevice categoryofmedicaldeviceintendedtomeettherequirementsforsterility Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide34 Terminology Validation confirmationbyexaminationandprovisionofobjectiveevidencethattheparticularrequirementsforaspecificintendedusearefulfilled processofexaminingaproducttodetermineconformitywithuserneedsVerification confirmationbyexaminationandprovisionofobjectiveevidencethatspecifiedrequirementshavebeenfulfilled processofexaminingtheresultofagivenactivitytodetermineconformitywiththestatedrequirementsforthatactivity Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide35 Questions ISO13485 Module4 QualityManagementSystems page4 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide37 4QualityManagementSystem 4 1GeneralRequirementsIdentifyprocessesSequenceandinteractionCriteriaandmethodofensuringeffectivenessResourcesMonitor measure analyzeImplement maintain Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide38 4QualityManagementSystem 4 2DocumentationrequirementsQualitypolicyQualityobjectivesQualitymanualProceduresDocumentsRecordsRegulatorydocumentation Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide39 4QualityManagementSystem 4 2 2QualityManualScopeofqualitymanagementsystemJustificationforexclusions non applicationsReferencetoproceduresInteractionbetweenprocessesStructureofdocumentationusedinQMS Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide40 4QualityManagementSystem 4 2 3ControlofdocumentsReviewandapprovalUpdateandre approvalRevisionstatusAvailableatpointofuseLegibleandidentifiableDocumentsofexternaloriginObsoletedocumentsRetentionperiod Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide41 Questions ISO13485 Module5 ManagementResponsibilityPage6 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide43 ManagementResponsibility 5 1ManagementCommitmentTopManagement policy objectives resources reviews communication5 2CustomerFocusTopManagement customerfocus5 3QualityPolicyTopManagement appropriate compliance effectiveness Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide44 ManagementResponsibility 5 4PlanningQualityobjectivesQualitymanagementsystemplanning5 5 1Responsibility authorityandcommunicationResponsibilitiesandauthorities defined documented communicatedInterrelationIndependence Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide45 ManagementResponsibility 5 5 2ManagementrepresentativeProcessesforQMSestablished implemented maintainedPerformanceofQMSreportedtoTopManagementEnsureawarenessofregulatoryandcustomerrequirements5 5 3Internalcommunication Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide46 ManagementResponsibility 5 6ManagementreviewPlannedintervals ensurecontinuingsuitability adequacy effectiveness5 6 2ReviewinputAudits customerfeedback processperformance productconformity statusofpreventiveandcorrectiveactions followupactionsfrompreviousreviews changes opportunitiesforimprovement neworrevisedregulatoryrequirements5 6 2ReviewoutputImprovements resourceneeds ISO13485 Module6 ResourceManagementPage8 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide48 ResourceManagement 6 1Provisionofresources6 2HumanresourcesCompetence awarenessandtraining6 3InfrastructureBuildings workspace utilitiesProcessequipment hardware software Supportingservices Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide49 ResourceManagement continued 6 4WorkenvironmentHealth cleanliness clothingWorkenvironmentconditionsTraining supervisionControlofcontaminatedproduct Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide50 TeamActivity 10min NewWaveMedicaldesignsandmanufacturesimplantableinsulinpumpsandanesthesiamachines Twonewstaffmembersarebeinghiredtoassistinthedevelopmentandmanufactureofanextgenerationproduct anelectricalengineerandamaintenancetechnicianforthecleanroomfacilities Determinethenecessarycompetenceforthesepersonnel preparinganoveralltrainingplan anddeterminehowtheeffectivenessofthetrainingwillbeassessed Recordyourfindingsonaflipchart Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide51 Questions ISO13485 Module7 ProductRealizationPage10 Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide53 ProductRealization 7 1PlanningofProductRealizationQualityobjectives productrequirementsProcesses documents resourcesVerification validation monitoring inspection test criteriaforacceptanceOutput7 2CustomerrelatedprocessesCustomerrequirementsStatutoryandregulatoryrequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide54 ProductRealization 7 2 2ReviewofrequirementsrelatedtotheproductContractreviewProductrequirementsdefinedanddocumentedDifferencesresolvedAbilitytomeetrequirementsRecordsofreviewChangecontrol7 2 3CustomercommunicationProductinformation enquiries contracts feedback advisorynotices Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide55 ProductRealization 7 3DesignanddevelopmentStagesReview verification validationanddesigntransferactivitiesInterfacesOutput7 3 2DesignanddevelopmentinputsFunctional performance safetyrequirementsStatutoryandregulatoryrequirementsInformationfromsimilardesignsOutputofriskmanagement Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide56 ProductRealization 7 3 3DesignanddevelopmentoutputsMeetinputrequirementsInformationforpurchasing production serviceProductacceptancecriteriaEssentialsafetyandusagecharacteristics7 3 4DesignanddevelopmentreviewAbilitytomeetrequirementsIdentifyproblemsandproposenecessaryactions7 3 5DesignanddevelopmentverificationVerifythatoutputsmeetinputrequirements Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide57 ProductRealization 7 3 6DesignanddevelopmentvalidationEnsurethatproductmeetsrequirementsforapplicationandintendeduseClinicalevaluations7 3 7ControlofdesignanddevelopmentchangesChangesreviewed verified approvedpriortoimplementationEvaluationofeffectsofchanges Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide58 ProductRealization 7 4PurchasingprocessSelectionofsuppliersEvaluation re evaluationControl7 4 2PurchasinginformationDescriptionofproducttobepurchasedRequirementsforapproval procedures processesandequipmentQualificationofpersonnelQMSrequirementsAdequacy Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide59 ProductRealization 7 4 3VerificationofpurchasedproductInspectionVerificationatsupplier spremisesMethodofproductrelease Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide60 ProductRealization 7 5Productionandserviceprovision7 5 1ControlofproductionandserviceprovisionsControlledconditionsInformationdescribingproductDocumentedprocedures requirements workinstructions referencematerial referencemeasurementproceduresSuitableequipmentMonitoringandmeasurement devicesRelease deliveryandpost deliveryactivitiesLabelingandpackagingBatchrecords Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide61 ProductRealization 7 5 1 2 1CleanlinessofproductandcontaminationcontrolCleanedpriortosterilizationand oruseCleanlinessisofsignificanceinuseProcessagentsremoved7 5 1 2 2InstallationactivitiesAcceptancecriteriaforinstallationVerificationofinstallationRequirementsRecords Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide62 ProductRealization 7 5 1 2 3Servicingactivities7 5 1 3ParticularrequirementsforsterilemedicaldevicesRecordsofprocessparametersBatchrecords Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide63 ProductRealization 7 5 2ValidationofprocessesforproductionandserviceprovisionValidationwhereresultingoutputcannotbeverifiedbysubsequentmonitoringormeasurement orwheredeficienciesbecomeapparentonlyaftertheproductisinuseortheservicehasbeendeliveredAbilitytoachieveplannedresultsCriteriaforreview approvalofprocessesApprovalofequipment qualificationofpersonnelMethods proceduresRecordsRevalidationSoftwareSterilization Copyright 2005UnderwritersLaboratoriesInc Allrightsreserved Slide64 ProductRealization 7 5 3IdentificationandtraceabilityIdentificationthroughoutproductrealizationTraceability uniqueidentificationImplantabledevices recordsofcomponents materials workenvironmentconditions distributionrecords shippingpackageconsigneeInspectionandteststatusCustomerproperty d