ISO9000GuidelineswithKeyRequirementsandHintsforImplementation2Section4.1ManagementResponsibility❖4.1.1QualityPolicy❖4.1.2Organization•4.1.2.1ResponsibilityandAuthority•4.1.2.2Resources•4.1.2.3ManagementRepresentative❖4.1.3ManagementReview3Section4.1ManagementResponsibilitySection4.1.1QualityPolicyKeyRequirements:☑Defineanddocumentcompanyqualitypolicies.☑Executivemanagementresponsibleforpolicy,includingobjectivesforqualityandcommitmenttoquality.☑Qualitypolicyshallberelevanttoorganizationalgoalsandneedsandexpectationsofitscustomers.☑Understood&practicedatalllevels.4Section4.1.1QualityPolicy(cont.)Hints:☺Knowwhatyourcompanyqualitypolicystatementmeans(Examplenextslide).☺KnowwheretheQualityPolicymanualisinyourarea.☺Understandwhatthismeanstoyouspecifically.5Section4.1.1QualityPolicy(cont.)“Qualityis...Wewillachievequalityby...”Quality=CustomerSatisfactionWewillusecontinualprocessimprovementWewillmakemanagementdecisionsbasedonfacts(metrics)Whatdoesitmean?1.2.3.6Section4.1ManagementResponsibilitySection4.1.2OrganizationKeyRequirements:☑Documentthequalityorganization(allthoseinvolvedinqualitytasks).☑Providenecessaryresources(people,training,etc.)formanagement,performanceofwork,andverificationactivities.☑Appointamanagementrepresentativewithexecutiveresponsibility:☑toensureanISOqualitysystemisestablished,implemented,andmaintained.☑toreportthequalitysystemperformancetomanagementforreviewandimprovement.7Section4.1ManagementResponsibilitySection4.1.2Organization(cont.)Hints:☺Knowwho’swhoinyourarea,i.e.whoistheQualitymanager?Whoperformsverificationactivities?Whoisauthorizedtoreviewandapprove?☺Knowwheretheaboveisdefinedanddocumented-i.e.organizationchart,jobdescriptions,procedures,etc.☺Knowwhothecompanymanagementrepresentativeisandtheirtitle.☺BesureyouhaveALLnecessaryresourcesforverificationtasks.8Section4.1ManagementResponsibilitySection4.1.3ManagementReviewKeyRequirements:Hints:☑ManagementwithexecutiveresponsibilityshallreviewtheQualitySystematdefinedintervalssufficienttoensureitseffectiveness.☑Recordsofmanagementreviewsmustbekept.☺Haveadocumented,annualplanforreviews.☺Toplevelmanagementmustattend.☺Includeintherecords:dates,attendees,inputstoreview(suchas:internalauditreports,metrics,customercomplaints,etc.),actionitems,follow-uptoactionitems.9Section4.2QualitySystem❖4.2.1General❖4.2.2QualitySystemProcedures❖4.2.3QualityPlanningInstructionManual1234510Section4.2QualitySystem(cont.)Rememberwhatthequalitysystemis...“Allplannedandsystematicactionsthatassurequality”Rememberwhatqualityis...“Meetingcustomerrequirements...”ISOdefinition“Customersatisfaction...continualprocessimprovement...managementbyfacts”YourQualityPolicydefinition11Section4.2QualitySystem(cont.)1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.16.17.18.19.20.ManagementResponsibilityQualitySystemContractReviewDesignControlDocumentandDataControlPurchasingControlofCustomer-SuppliedProductProductIdentificationandTraceabilityProcessControlInspectionandTestingControlofInspection,Measuring&TestEquipmentInspectionandTestStatusControlofNonconformingProductCorrectiveandPreventiveActionHandling,Storage,Packaging,Preservation&DeliveryControlofQualityRecordsInternalQualityAuditsTrainingServicingStatisticalTechniquesRemembertheISOqualitysystemframework...12Section4.2QualitySystem(cont.)QMProceduresWorkInstruct...
