ISO9000GuidelinesWithKeyRequirements24.1ManagementResponsibility❖Executivemanagementdefinespolicyforquality,companyobjectives&commitmenttoquality❖Policy&objectivesareunderstoodandimplementedatalllevels❖Clearauthorities&responsibilitiesaredefined❖Resourcesidentified&provided❖Executivemanagementrepresentativeassigned❖Periodic,managementreviewsofthequalitysystem-Isiteffective?3❖Musthaveaqualitymanual❖Addressallrequirementsofthestandard❖Documenthowitwillconform❖Effectiveimplementation❖Mustdefine/documentqualityplanning4.2QualitySystemASQCDefinitionQualitySystem:Theorganizationalstructure,responsibilities,procedures,processes,andresourcesforimplementingqualitymanagementInstructionManual1234544.3ContractReviewCustomerSupplier❖Customer’srequirementsmustbeclear(writtenororal)❖Suppliermusthavethecapability❖Processforchangingrequirements/acceptancetestingofproductmustbedefined54.4DesignControl❖Methodologyfordesignprocess❖Translatecustomerrequirements❖Identifyresponsibilityforeachstep❖Definealldesigninputs/outputs❖Conductdesignreviews❖Controldesignchanges❖Designverificationandproductvalidation64.5DocumentandDataControl❖Controlalldocuments❖Reviewandapprovalbyauthorizedpersonnel❖Obsoletedocumentsoutofcirculation❖Trackcurrentversions/issues❖Identifychangesonthedocument❖Determineappropriateintervalofreissue74.6Purchasing❖Purchasedproductconformstospecifications❖Sub-contractorselectedbasedoncriteria❖Recordsofacceptablesub-contractors❖Manyformsofcontrolpossible❖PurchasingdocumentsclearandcompleteSUBSTITUTEITEMPURCHASEORDERNo.890VendorNo.1304ItemNo.2784.7ControlofCustomerSuppliedProductEngineRebuildersInc.❖Customersuppliesmaterialtosupplier•suppliermustinspectandstoreproperly•mark/identifyproduct•reporttocustomeranylost,damagedorunsuitablematerial94.8ProductIdentificationandTraceability123451234512345•Materialsandproductsproperlyidentifiedthroughouttheentireprocess(receiptthenshipment)104.9ProcessControl❖Workinstructions❖Suitableequipment/environment❖Processcapability❖Approvalsandqualifications❖Workmanshipcriteria❖Includesafter-salesserviceprocesses114.10InspectionandTesting❖Inspecttoensurethatproductmeetsspecifications:•Receiving•In-process•Final❖Keeprecords12❖Control,calibrateandmaintaininspection,measuringandtestequipment❖Keepalistofallequipment❖Methodsofcalibrationformallydefinedforallmeasuringandtestequipment❖Evidencethaterrorsofallmeasuringandtestequipmentareknown❖Statusofcalibrationonequipmentoreasilyattainable❖Maintainrecords❖SeeISO100124.11ControlofInspection,Measuring,andTestEquipment134.12InspectionandTestStatus❖Throughoutthecycle,ProductmustbeclearlymarkedconcerningitsInspectionorTestStatusPRODUCTSTATUS144.13ControlofNonconformingProduct❖Nonconformingproductmustbe:•marked•segregated•recorded•dispositioned❖ResponsibilitiesandproceduresforReviewandDisposition154.14CorrectiveandPreventiveAction❖Determinecauseofnonconformingproductsolastingsolutioncanbefound❖DetectionandpreventionofpotentialproblemsRecognitionofProblemAnalyzeProblemIdentifyCauseTakeCorrectiveActionMonitorEffectivenessDocumentCustomerAuditProcessProduct164.15Handling,Storage,Packaging,PreservationandDelivery❖Preventdamageordeterioration❖Securearea/controlledarea❖Identifyandprotecttheproduct❖Ifincontract,properprotectionthroughdeliveryandinstallation174.16ControlofQualityRecords❖Methodfor:•identifying•collecting•indexing•access•filing•storage•maintenance•disposition❖Identifiabletotheareaorproductinvolved❖Determinelengthofretention184.17InternalQualityAudits❖Independentpersonnel❖Auditsmustbeplanned,documentedandscheduled❖Musthavesystemforauditsandfollow-up❖Documentedresults19•Identifytrainingneeds•Providepropertrainingwherenecessary•Keeprecordsoftraining4.18Training204.19Servicing❖Maintainproceduresforserviceprocesses:•Performing•Verifying•Reporting214.20StatisticalTechniquesvIdentifytheneedforstatisticaltechniquesvMaintainproceduresforimplementationandcontrol1stQtr2ndQtr3rdQtr4thQtr01020304050607080901stQtr2ndQtr3rdQtr4thQtr
