Beruflich Dokumente
Kultur Dokumente
InPlainEnglish
CreatedbyLarryWhittington
RABQSALeadQMSAuditor(2406) IRCALeadQMSAuditor(A6472) ASQSeniorMember Whittington&Associates,LLC
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Contents
4.QualityManagementSystem
4.1GeneralRequirements
Establish,document,implement,andmaintainaqualitymanagementsystem.Continually improveitseffectivenessinaccordancewithISO9001requirements.Implementthesystemto:
ManagetheseprocessesinaccordancewithISO9001requirements.Definethetypeandextent ofcontrolappliedtoanyoutsourcedprocessesthataffectproductconformitytorequirements. NOTE1:Processesneededforthequalitymanagementsystemincludetheprocessesfor managementactivities(see5),provisionofresources(see6),productrealization(see7),and measurement,analysis,andimprovement(see8). NOTE2:Anoutsourcedprocessisaprocesstheorganizationneedsforitsqualitymanagement system,andwhichtheorganizationchoosestohaveperformedbyanexternalparty. NOTE3:Ensuringcontroloveroutsourcedprocessesdoesnotabsolveyourorganizationofthe responsibilitytoconformtoallcustomer,statutory,andregulatoryrequirements.Thetypeand extentofcontrolappliedtoanoutsourcedprocesscanbeinfluencedbyfactorssuchas: Potentialimpactoftheoutsourcedprocessonyourorganization'scapabilitytoprovide productthatconformstorequirements Degreetowhichthecontrolfortheprocessisshared Capabilityofachievingthenecessarycontrolthroughtheapplicationof7.4
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4.2DocumentationRequirements
4.2.1GeneralRequirements Includeinthequalitymanagementsystemdocumentation:
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Establishadocumentedprocedureto:
Keeprecordslegible,readilyidentifiable,andretrievable.
5.ManagementResponsibility
Allrequirementsinclause5aretheresponsibilityoftopmanagement.
5.1ManagementCommitment
Provideevidenceofmanagementcommitmenttodevelopandimplementthequality managementsystem,aswellas,continuallyimproveitseffectivenessby:
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5.2CustomerFocus
Ensurecustomerrequirementsaredeterminedandmetinordertoimprovecustomer satisfaction.
5.3QualityPolicy
Ensurethequalitypolicyis:
5.4Planning
5.4.1QualityObjectives Ensurequalityobjectives,includingthoseneededtomeetproductrequirements,are establishedattherelevantfunctionsandlevelswithintheorganization.Ensurequality objectivesaremeasurableandconsistentwiththequalitypolicy. 5.4.2QualityManagementSystemPlanning Ensurethatplanningforthequalitymanagementsystem:
Meetsthegeneralrequirements(4.1),aswellas,qualityobjectives(5.4.1) Maintainsthesystemintegritywhenchangesareplannedandimplemented
5.5Responsibility,Authority,andCommunication
5.5.1ResponsibilityandAuthority Ensureresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization. 5.5.2ManagementRepresentative Appointamemberofyourmanagementwho,irrespectiveofotherduties,hasthe responsibilityandauthorityto:
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5.6ManagementReview
5.6.1General Reviewthequalitymanagementsystematplannedintervalsto:
5.6.3ReviewOutput Outputsfromthemanagementreviewmustincludeanydecisionsandactionsrelatedto:
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6.ResourceManagement
6.1ProvisionofResources
Determineandprovidetheresourcesnecessaryto:
6.2HumanResources
6.2.1General Ensurepeopleperformingworkaffectingconformitytoproductrequirementsarecompetent basedontheappropriateeducation,training,skills,andexperience. NOTE:Conformitytoproductrequirementscanbeaffecteddirectly,orindirectly,bypersonnel performinganytaskwithinthequalitymanagementsystem. 6.2.2Competence,Training,andAwareness Theorganizationmust:
6.3Infrastructure
Determine,provide,andmaintainthenecessaryinfrastructuretoachieveproductconformity. Infrastructureincludes,asapplicable:
Buildings,workspace,andassociatedutilities
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Processequipment(bothhardwareandsoftware) Supportingservices(suchastransport,communication,orinformationsystems)
6.4WorkEnvironment
Determineandmanagetheworkenvironmentneededtoachieveproductconformity. NOTE:Thetermworkenvironmentrelatestothoseconditionsunderwhichworkis performed,includingphysical,environmental,andotherfactorssuchasnoise,temperature, humidity,lighting,orweather.
7.ProductRealization
7.1PlanningofProductRealization
Plananddeveloptheprocessesneededforproductrealization.Keeptheplanningconsistent withotherrequirementsofthequalitymanagementsystemanddocumentitinasuitableform fortheorganization.Determinethroughtheplanning,asappropriate,the:
7.2CustomerRelatedProcesses
7.2.1DeterminationofRequirementsRelatedtotheProduct Determinecustomerrequirements:
Specifiedfortheproduct(includingdeliveryandpostdeliveryactivities) Notspecifiedfortheproduct(butneededforspecifiedorintendeduse,whereknown)
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Determine:
Statutoryandregulatoryrequirementsapplicabletotheproduct Anyadditionalrequirementsconsiderednecessarybytheorganization
7.3DesignandDevelopment
7.3.1DesignandDevelopmentPlanning Planandcontroltheproductdesignanddevelopment.Thisplanningmustdeterminethe:
Stagesofdesignanddevelopment Appropriatereview,verification,andvalidationactivitiesforeachstage
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Responsibilityandauthorityfordesignanddevelopment
Evaluatetheabilityoftheresultstomeetrequirements Identifyproblemsandproposeanynecessaryactions
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Performvalidationinaccordancewithplannedarrangements(see7.3.1)toconfirmthe resultingproductiscapableofmeetingtherequirementsforitsspecifiedapplicationor intendeduse,whereknown.Whenpractical,completethevalidationbeforedeliveryor implementationoftheproduct.Maintaintheresultsofthevalidationandsubsequentfollowup actions. 7.3.7ControlofDesignandDevelopmentChanges Identifydesignanddevelopmentchangesandmaintainrecords.Review,verify,andvalidate(as appropriate)thechangesandapprovethembeforeimplementation.Evaluatethechangesin termsoftheireffectonconstituentpartsandproductsalreadydelivered.Maintaintheresults ofthechangereviewandsubsequentfollowupactions.
7.4Purchasing
7.4.1PurchasingProcess Ensurethatpurchasedproductconformstoitsspecifiedpurchaserequirements.Thetypeand extentofcontrolappliedtothesupplierandpurchasedproductdependsupontheeffectofthe productonthesubsequentrealizationprocessesorthefinalproduct. Evaluateandselectsuppliersbasedontheirabilitytosupplyproductinaccordancewiththe requirements.Establishthecriteriaforselection,evaluation,andreevaluation.Maintainthe resultsoftheevaluationsandsubsequentfollowupactions. 7.4.2PurchasingInformation Ensurethepurchasinginformationcontainsinformationdescribingtheproducttobe purchased,includingtherequirementsfor:
Approvalofproduct,procedures,processes,andequipment
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Qualificationofpersonnel
7.5ProductionandServiceProvision
7.5.1ControlofProductionandServiceProvision Planandcarryoutproductionandserviceprovisionundercontrolledconditionstoinclude,as applicable:
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Revalidation
7.5.3IdentificationandTraceability Identify,whereappropriate,theproductbysuitablemeansduringproductrealization.Identify theproductstatuswithrespecttomonitoringandmeasurementrequirementsthroughout productrealization.Wheretraceabilityisarequirement,controltheuniqueidentificationofthe productandmaintainrecords. NOTE:Insomeindustrysectors,configurationmanagementisameansbywhichidentification andtraceabilityaremaintained. 7.5.4CustomerProperty Exercisecarewithanycustomerpropertywhileitisunderthecontrolof,orbeingusedby,the organization.Identify,verify,protect,andsafeguardcustomerpropertyprovidedforuse,orfor incorporationintotheproduct.Recordandreportanylost,damaged,orunsuitablepropertyto thecustomer. NOTE:Customerpropertycanincludeintellectualpropertyandpersonaldata. 7.5.5PreservationofProduct Preservetheproductduringinternalprocessinganddeliverytotheintendeddestinationin ordertomaintainconformitytorequirements.Asapplicable,preservationincludes:
Alsoapplypreservationtotheconstituentpartsoftheproduct.
7.6ControlofMeasuringandMonitoringEquipment
Determinethemonitoringandmeasurementstobemade,andtherequiredequipment,to provideevidenceofproductconformity.Useandcontrolthemonitoringandmeasuringdevices toensurethatmeasurementcapabilityisconsistentwithmonitoringandmeasurement requirements. Wherenecessarytoensurevalidresults:
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8.Measurement,Analysis,andImprovement
8.1General
Planandimplementthemonitoring,measurement,analysis,andimprovementprocesses neededto:
Determinethroughplanningtheneedfor,anduseof,applicablemethods,includingstatistical techniques,aswellas,theextentoftheiruse.
8.2MonitoringandMeasurement
8.2.1CustomerSatisfaction Monitorinformationoncustomerperceptionastowhethertheorganizationismeeting requirements(asoneoftheperformancemeasurementsofthequalitymanagementsystem). Definethemethodsforobtainingandusingthisinformation. NOTE:Monitoringcustomerperceptioncanincludeobtaininginputfromsourcessuchas customersatisfactionsurveys,customerdataondeliveredproductquality,useropinion surveys,lostbusinessanalysis,compliments,warrantyclaims,anddealerreports.
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8.2.2InternalAudit Conductinternalauditsatplannedintervalstodetermineifthequalitymanagementsystem:
Theorganizationmust:
Establishadocumentedproceduretoaddressresponsibilitiesandrequirementsto:
Planauditsandconductaudits Establishrecordsandreportresults
Maintainrecordsoftheauditsandtheirresults. Ensuremanagementoftheauditedareastakesactionswithoutunduedelaytoeliminate detectednonconformitiesandtheircauses.Verifythroughfollowupactionsthe implementationoftheactionandreporttheresults. NOTE:SeeISO19011forauditguidance. 8.2.3MonitoringandMeasurementofProcesses Applysuitablemethodsformonitoringand,whereapplicable,measurementofthequality managementsystemprocesses.Confirmthroughthesemethodsthecontinuingabilityofeach processtosatisfyitsintendedpurpose.Whentheplannedresultsarenotachieved,take correctionandcorrectiveaction,asappropriate. NOTE:Whendeterminingsuitablemethods,considerthetypeandextentofmonitoringor measurementforeachprocessinrelationtoitsimpactonproductconformityandonthe effectivenessofthequalitymanagementsystem.
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8.3ControlofNonconformingProduct
Ensureanynonconformingproductisidentifiedandcontrolledtopreventitsunintendeduseor delivery.Establishadocumentedproceduretodefinethecontrolsandrelatedresponsibilities andauthoritiesfordealingwithnonconformingproduct. Whereapplicable,dealwiththenonconformingproductbyoneormoreofthefollowingways:
Maintainrecordsofthenatureofthenonconformity,andanysubsequentactions,(including anyconcessions).Whenthenonconformityiscorrected,reverifyittoshowconformity.
8.4AnalysisofData
Determine,collect,andanalyzeappropriatedatatodemonstratethesuitabilityand effectivenessofthequalitymanagementsystem,aswellas,evaluatewherecontinual improvementoftheeffectivenessofthequalitymanagementsystemcanbemade.Includein theanalysisthedatageneratedbymonitoringandmeasuringactivitiesandfromotherrelevant sources.Analyzethisdatatoprovideinformationon:
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8.5Improvement
8.5.1ContinualImprovement Continuallyimprovetheeffectivenessofthequalitymanagementsystemthrough:
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