Quality-Manual-1

NDCQualityManualQM-0000,Rev.PPage1of34NDCConfidentialQM-0000,Rev.P.docNDCQualityManual1IntroductiontoNitinolDevices&Components(NDC)1.1AboutNDCNDCisadeveloperandmanufacturerofNitinolbasedcomponentsforbothmedicalandcommercialapplications.NDCislocatedinFremont,California.1.2RegistrationsISO13485:2003BSI#FM78817,NDC,Fremont,CaUSFDARegistration#2951217:NDC,Fremont,Ca-InactiveStateofCaliforniaDHS#Pending(submittedforregistration):NDC,Fremont,Ca1.4ReferencesISO13485:2003:“MedicalDevices–QualityManagementSystems–RequirementsforRegulatoryPurposes”ISO14971:2000,MedicalDevices-ApplicationofriskmanagementtomedicaldevicesTitle21CFRPart820,FoodandDrugAdministration,“QualitySystemRegulation”Title21CFRPart11,FoodandDrugAdministration,“ElectronicRecords;ElectronicSignatures”MinistryofHealth,LaborandWelfare(MHLW)OrdinanceNo.169,20042Scope2.1ApplicationNDCdesigns,developsandmanufacturesmedicaldevicecomponentsandrawmaterials(forbothmedicalandnon-medicaluses).2.2ExclusionsTheexclusionsforthebusinessareasfollows:1.Thecompanydoesnotprovideinstallationorservicingforthecustomers.TheinstallationandservicingrequirementsofSections7.5.1.2.2InstallationActivitiesand7.5.1.2.3ServicingActivitiesareexcludedfromthisqualitysystem.NDCQualityManualQM-0000,Rev.PPage2of34NDCConfidentialQM-0000,Rev.P.doc3QualitySystemOverview3.1NDCQualityPolicyEveryoneatNDCisresponsibleforthequalityofhisorherwork.NDCwillachievethiscommitmentby:•Meetingregulatoryrequirementsandintegratingqualitythroughinnovation,talent,designandprofoundprocessknowledge.•Focusingtalentsonmonitoringandcontinuouslyimprovingdesign,qualitysystemsandprocessestobetterserveourcustomers,themedicalcommunityandmeetingorexceedingworldwidequalityandregulatoryrequirements.3.2NDCQualityObjectivesNDCconsidersthesafety,efficacyandqualityofourproductstobeofutmostimportance.Thesehigh-levelqualityobjectivesarederivedfromtheQualityPolicyandarethefoundationfromwhichallqualitygoalsandactivitiesaredeveloped.TheQualityObjectivesandgoalsorchangestothemaregeneratedduringtheManagementReviewmeetingsandrecordedonmanagementreviewmeetingnotes.Ingeneral,theQualityObjectivesincludeProductPerformance,CustomerCommunication(Complaints,returns,deliveryperformance),Suppliermanagement,Training,CorrectiveandPreventiveActions,andEnvironmental,HealthandSafetymanagementandothers.3.3OrganizationalStructureTheNDCorganizationalstructureismaintainedasaseparatedocument.AnapprovedcopyismaintainedbytheQualitySystemsdepartment.4QualityManagementSystem4.1GeneralRequirementsTheNDCQualityManagementSystemisestablishedtoimplementtherequirementsofISO13485:2003,USFDA21CFRPart820,QualitySystemRegulationandotherstandards,andtoestablishpoliciesandproceduresthatsupporttheobjectivesofthecompany.TheManagementwithExecutiveResponsibilityapprovesinitialreleaseandchangestothisdocumentthroughtheEngineeringChangeOrder(ECO)process.TheprocessneededforthemanagementoftheQMSconsistof:•ProductRealization,wherenewproductisdevelopedbasedoncustomerneedsandtransferredtomanufacturing,•Deliverytocustomersand•UsingcustomerfeedbacktomakeimprovementstotheProductRealizationprocess.NDCQualityManualQM-0000,Rev.PPage3of34NDCConfidentialQM-0000,Rev.P.docInaddition,InternalAuditsandManagementReviewprocessesareusedtoevaluatetheeffectivenessofqualitysystemanddriveimprovementbymonitoringandmeasuringtheoutcomeoftheseprocesses.ManagementReviewalsoensuresavailabilityofadequateresourcesandtechnologytosupporttheQMS.ThisQualityManualprovidespolicyandothertop-levelguidance(LevelI),andmakesreferencetoOperatingProceduresfordetailedproceduresontheoperationoftheSystem(LevelII).DetailedproceduresformanufacturingandsupportingactivitiesarefoundinTravelers,WorkInstructions,InspectionPlansandotherLevelIIIdocuments.TheauthoritytoperformthetasksidentifiedinthisdocumentandotherQualitySystemdocumentsmaynotbedelegatedunlessspecificallystatedotherwise.Suchdelegationistobeinwriting,andtheoverallresponsibilityforproperperformanceofthetaskremainswiththeindividualreferredtointhedocumentation.Thescopeofthequalitysystemcoversproductionofstandardproductandallsupportingactivities.Designanddevelopmentactivitiesarealsocovered.TheresponsibilityfortheNDCqualitysystemhasbeenassignedtoManagementwithExecutiveResponsibility(MWER).TheVicePresidentofQualityAssurancehasbeendesignatedbythePresidentofNDCtobetheManagementRepresentativewithfullresponsibilityandauthorityforestablishingandmaintainingthequalitysysteminaccordancewithQualitySystemrequirements.NDCQualityManualQM-0000,Rev.PPage4of34NDCConfidentialQM-0000,Rev.P.docTheprocessdepictedbelowprovidesanoverviewoftheNDCQualitySystemmodel.TheclosedloopprocessensuresthatNDChasnotonlyestablished,butalsoimprovesprocessesandpracticesonacontinuousbasis.CNCCQualitySystemCustomerSatisfactionNDCQualityPolicy5.0ManagementResponsibilityOP-9001(series)OP-9003(series)OtherproceduresTBD6.0ResourceManagementOrganizationChartOP-9009-3,7,8OP-9018OP-9021(series)OtherproceduresTBD8.0Measurement,AnalysisandImprovementOP-9010(series)OP-9013(series)OP-9014(series)OP-9017OP-9020Otherproce