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ISO9001:2008 Requirements Summary

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:

Determineprocessesneededforthequalitymanagementsystem(andtheirapplication throughouttheorganization) Determineprocesssequenceandinteraction Determinecriteriaandmethodsforprocessoperationandcontrol Ensureresourcesandsupportinginformationareavailable Monitor,measurewhereapplicable,andanalyzetheseprocesses Implementactionstoachieveplannedresultsandcontinualprocessimprovement

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:

Documentedstatementsofaqualitypolicyandqualityobjectives Aqualitymanual DocumentedproceduresandrecordsrequiredbyISO9001 Documentsandrecordsdeterminedbytheorganizationtobenecessaryforthe effectiveplanning,operation,andcontrolofitsprocesses

NOTE1:WheredocumentedprocedureappearswithintheStandard,thismeansthatthe procedureisestablished,documented,implemented,andmaintained.Asingledocumentmay addresstherequirementsforoneormoreprocedures.Arequirementforadocumented proceduremaybecoveredbymorethanonedocument. NOTE2:Theextentofthequalitymanagementsystemdocumentationcandifferfromone organizationtoanotherdueto:


Sizeoftheorganizationandtypeofactivities Complexityofprocessesandtheirinteractions Competenceofpersonnel

NOTE3:Thedocumentationcanbeinanyformortypeofmedium. 4.2.2QualityManual Establishandmaintainaqualitymanualwith:


Scopeofthequalitymanagementsystem Detailsandjustificationforanyexclusions Proceduresorreferencestotheprocedures Descriptionofinteractionbetweenprocesses

4.2.3ControlofDocuments Controlthedocumentsrequiredbythequalitymanagementsystem.Recordsareaspecialtype ofdocumentandmustbecontrolledasrequiredbyclause4.2.4.

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Establishadocumentedprocedureto:

Approvedocumentsforadequacypriortoissue Review,updateasnecessary,andreapprovedocuments Identifythechangesandcurrentdocumentrevisionstatus Makerelevantdocumentsavailableatpointsofuse Ensurethedocumentsremainlegibleandreadilyidentifiable Identifyexternaldocumentsandcontroltheirdistribution Preventobsoletedocumentsfromunintendeduse Applysuitableidentificationifobsoletedocumentsareretained

4.2.4ControlofRecords Establishandcontrolrecordsasevidenceofconformitytorequirementsandtodemonstrate theeffectiveoperationofthequalitymanagementsystem. Establishadocumentedproceduretodefinethecontrolsneededforrecord:


Identification Storage Protection Retrieval Retention Disposition

Keeprecordslegible,readilyidentifiable,andretrievable.

5.ManagementResponsibility
Allrequirementsinclause5aretheresponsibilityoftopmanagement.

5.1ManagementCommitment
Provideevidenceofmanagementcommitmenttodevelopandimplementthequality managementsystem,aswellas,continuallyimproveitseffectivenessby:

Expressingtheimportanceofmeetingrequirements Establishingthequalitypolicyandqualityobjectives Conductingmanagementreviews Ensuringtheavailabilityofnecessaryresources

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5.2CustomerFocus
Ensurecustomerrequirementsaredeterminedandmetinordertoimprovecustomer satisfaction.

5.3QualityPolicy
Ensurethequalitypolicyis:

Appropriatetothepurposeoftheorganization Focusedonmeetingrequirementsandcontinualimprovement Usedasaframeworkforqualityobjectives Communicatedandunderstoodatappropriatelevels Reviewedforcontinuingsuitability

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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Ensuretheneededprocessesareestablished,implemented,andmaintained Reporttotopmanagementonqualitymanagementsystemperformance Reporttotopmanagementonanyneedforimprovement Ensuringthepromotionofawarenessofcustomerrequirements

NOTE:Theresponsibilityofamanagementrepresentativecanincludebeingtheliaisonwith externalpartiesonmattersrelatingtothequalitymanagementsystem. 5.5.3InternalCommunication Ensuretheappropriatecommunicationprocessesareestablishedandcarriedoutwithinthe organizationregardingtheeffectivenessofthesystem.

5.6ManagementReview
5.6.1General Reviewthequalitymanagementsystematplannedintervalsto:

Ensureasuitable,adequate,andeffectivesystem Assesspossibleopportunitiesforimprovement Evaluatetheneedforanychangestothesystem Considertheneedforchangestothequalitypolicyandobjectives

Maintainrecordsofthemanagementreviews. 5.6.2ReviewInput Inputsformanagementreviewmustincludeinformationon:


Resultsofaudits Customerfeedback Processperformanceandproductconformity Statusofpreventiveandcorrectiveactions Followupactionsfromearlierreviews Changesthatcouldaffectthequalitysystem Recommendationsforimprovement

5.6.3ReviewOutput Outputsfromthemanagementreviewmustincludeanydecisionsandactionsrelatedto:

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Improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses Improvementofproductrelatedtocustomerrequirements Resourceneeds

6.ResourceManagement
6.1ProvisionofResources
Determineandprovidetheresourcesnecessaryto:

Implementandmaintainthequalitymanagementsystem Continuallyimprovetheeffectivenessofthesystem Enhancecustomersatisfactionbymeetingcustomerrequirements

6.2HumanResources
6.2.1General Ensurepeopleperformingworkaffectingconformitytoproductrequirementsarecompetent basedontheappropriateeducation,training,skills,andexperience. NOTE:Conformitytoproductrequirementscanbeaffecteddirectly,orindirectly,bypersonnel performinganytaskwithinthequalitymanagementsystem. 6.2.2Competence,Training,andAwareness Theorganizationmust:

Determinethecompetencyneedsforpersonnel Providetraining(ortakeotheractions)toachievethenecessarycompetence Evaluatetheeffectivenessoftheactionstaken Informemployeesoftherelevanceandimportanceoftheiractivities Ensuretheyknowtheircontributiontoachievingqualityobjectives Maintaineducation,training,skill,andexperiencerecords

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:

Qualityobjectivesandproductrequirements Needforprocesses,documents,andresources Verification,validation,monitoring,measurement,inspection,andtestactivities Criteriaforproductacceptance Recordsasevidencetheprocessesandresultingproductmeetrequirements

NOTE1:Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingthe productrealizationprocesses),andtheresourcestobeappliedtoaspecificproduct,projector contract,canbereferredtoasaqualityplan. NOTE2:Theorganizationcanalsoapplytherequirementsgivenin7.3tothedevelopmentof productrealizationprocesses.

7.2CustomerRelatedProcesses
7.2.1DeterminationofRequirementsRelatedtotheProduct Determinecustomerrequirements:

Specifiedfortheproduct(includingdeliveryandpostdeliveryactivities) Notspecifiedfortheproduct(butneededforspecifiedorintendeduse,whereknown)

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Determine:

Statutoryandregulatoryrequirementsapplicabletotheproduct Anyadditionalrequirementsconsiderednecessarybytheorganization

NOTE:Postdeliveryactivitiesincludeactionsunderwarrantyprovisions,contractualobligations suchasmaintenanceservices,andsupplementaryservicessuchasrecyclingorfinaldisposal. 7.2.2ReviewofRequirementsRelatedtotheProduct Reviewtheproductrequirementsbeforecommittingtosupplytheproducttothecustomerin orderto:


Ensureproductrequirementsaredefined Resolveanyrequirementsdifferingfromthosepreviouslyexpressed Ensureitsabilitytomeettherequirements

Maintaintheresultsofthereview,andanysubsequentfollowupactions.Whenthe requirementsarenotdocumented,theymustbeconfirmedbeforeacceptance. Ifproductrequirementsarechanged,ensurerelevantdocumentsareamendedandrelevant personnelaremadeawareofthechangedrequirements. NOTE:Insomesituations,suchasinternetsales,aformalreviewisimpracticalforeachorder. Instead,thereviewcancoverrelevantproductinformationsuchascatalogsoradvertising material. 7.2.3CustomerCommunication Determineandimplementeffectivearrangementsforcommunicatingwithcustomerson:


Productinformation Inquiries,contracts,ororderhandling(includingamendments) Customerfeedback(includingcustomercomplaints)

7.3DesignandDevelopment
7.3.1DesignandDevelopmentPlanning Planandcontroltheproductdesignanddevelopment.Thisplanningmustdeterminethe:

Stagesofdesignanddevelopment Appropriatereview,verification,andvalidationactivitiesforeachstage
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Responsibilityandauthorityfordesignanddevelopment

Theinterfacesbetweenthedifferentinvolvedgroupsmustbemanagedtoensureeffective communicationandtheclearassignmentofresponsibility.Update,asappropriate,theplanning outputduringdesignanddevelopment. NOTE:Designanddevelopmentreview,verification,andvalidationhavedistinctpurposes.They canbeconductedandrecordedseparatelyorinanycombination,asdeemedsuitableforthe productandtheorganization. 7.3.2DesignandDevelopmentInputs Determineproductrequirementinputsandmaintainrecords.Theinputsmustinclude:


Functionalandperformancerequirements Applicablestatutoryandregulatoryrequirements Applicableinformationderivedfromsimilardesigns Requirementsessentialfordesignanddevelopment

Reviewtheseinputsforadequacy.Resolveanyincomplete,ambiguous,orconflicting requirements. 7.3.3DesignandDevelopmentOutputs Documenttheoutputsofthedesignanddevelopmentprocessinaformsuitableforverification againsttheinputstotheprocess.Theoutputsmust:


Meetdesignanddevelopmentinputrequirements Provideinformationforpurchasing,production,andservice Containorreferenceproductacceptancecriteria Defineessentialcharacteristicsforsafeandproperuse Beapprovedbeforetheirrelease

NOTE:Informationforproductionandservicecanincludedetailsforproductpreservation. 7.3.4DesignandDevelopmentReview Performsystematicreviewsofdesignanddevelopmentatsuitablestagesinaccordancewith plannedarrangements(see7.3.1)to:


Evaluatetheabilityoftheresultstomeetrequirements Identifyproblemsandproposeanynecessaryactions

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Thereviewsmustincluderepresentativesofthefunctionsconcernedwiththestagebeing reviewed.Maintaintheresultsofreviewsandsubsequentfollowupactions. 7.3.5DesignandDevelopmentVerification Performdesignanddevelopmentverificationinaccordancewithplannedarrangements(see 7.3.1)toensuretheoutputmeetsthedesignanddevelopmentinputrequirements.Maintain theresultsoftheverificationandsubsequentfollowupactions. 7.3.6DesignandDevelopmentValidation

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

(Alsoincludequalitymanagementsystemrequirementsinthepurchasinginformation) Ensuretheadequacyofthespecifiedrequirementsbeforecommunicatingtheinformationto thesupplier. 7.4.3VerificationofPurchasedProduct Establishandimplementtheinspectionorothernecessaryactivitiesforensuringthepurchased productsmeetthespecifiedpurchaserequirements.Iftheorganizationoritscustomer proposestoverifytheproductatthesupplierlocation,statetheintendedverification arrangementsandmethodofproductreleaseinthepurchasinginformation.

7.5ProductionandServiceProvision
7.5.1ControlofProductionandServiceProvision Planandcarryoutproductionandserviceprovisionundercontrolledconditionstoinclude,as applicable:

Availabilityofproductcharacteristicsinformation Availabilityofworkinstructions,asnecessary Useofsuitableequipment Availabilityanduseofmonitoringandmeasuringequipment Implementationofmonitoringandmeasurementactivities Implementationofproductrelease,delivery,andpostdeliveryactivities

7.5.2ValidationofProcessesforProductionandServiceProvision Validateanyproductionorserviceprovisionwheresubsequentmonitoringormeasurement cannotverifytheoutput.Thisvalidationincludesprocesseswheredeficienciesmaybecome apparentonlyafterproductuseorservicedelivery.Demonstratethroughthevalidationthe abilityofprocessestoachievetheplannedresults. Establishvalidationarrangementsincluding,asapplicable:


Criteriaforprocessreviewandapproval Approvalofequipment Qualificationofpersonnel Useofdefinedmethodsandprocedures Requirementsforrecords

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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:

Identification Handling Packaging Storage Protection

Alsoapplypreservationtotheconstituentpartsoftheproduct.

7.6ControlofMeasuringandMonitoringEquipment
Determinethemonitoringandmeasurementstobemade,andtherequiredequipment,to provideevidenceofproductconformity.Useandcontrolthemonitoringandmeasuringdevices toensurethatmeasurementcapabilityisconsistentwithmonitoringandmeasurement requirements. Wherenecessarytoensurevalidresults:

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Calibrateand/orverifythemeasuringequipmentatspecifiedintervalsorpriortouse Calibratetheequipmenttonationalorinternationalstandards(orrecordotherbasis) Adjustorreadjustasnecessary Identifythemeasuringequipmentinordertodetermineitscalibrationstatus Safeguardthemfromimproperadjustments Protectthemfromdamageanddeterioration

Assessandrecordthevalidityofpriorresultsifthedeviceisfoundtonotconformto requirements.Maintainrecordsofthecalibrationandverificationresults. Confirmtheabilityofsoftwareusedformonitoringandmeasuringfortheintendedapplication beforeitsinitialuse(andreconfirmedasnecessary). NOTE:Confirmingtheabilityofsoftwaretosatisfytheintendedapplicationwouldtypically includeitsverificationandconfigurationmanagementtomaintainitssuitabilityforuse.

8.Measurement,Analysis,andImprovement
8.1General
Planandimplementthemonitoring,measurement,analysis,andimprovementprocesses neededto:

Demonstrateconformitytoproductrequirements Ensureconformityofthesystem Continuallyimproveeffectiveness

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:

Conformstoplannedarrangements(see7.1) ConformstorequirementsofISO9001 Iseffectivelyimplementedandmaintained

Theorganizationmust:

Plantheauditprogram Considerthestatusandimportanceoftheauditedareas Considertheresultsofprioraudits Definetheauditcriteria,scope,frequency,andmethods Selectanduseimpartialandobjectiveauditors(notaudittheirownwork)

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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8.2.4MonitoringandMeasurementofProduct Monitorandmeasureproductcharacteristicstoverifyproductrequirementsarebeingmet. Carryoutthemonitoringandmeasuringattheappropriatestagesofproductrealizationin accordancewithplannedarrangements(see7.1).Maintainevidenceofconformitywiththe acceptancecriteria. Recordthepersonresponsibleforauthorizingreleaseofproductfordeliverytothecustomer. Productreleaseandservicedeliverycannotproceeduntilallplannedarrangements(see7.1) havebeensatisfactorilycompleted,unlessotherwiseapprovedbyarelevantauthority,and whereapplicable,thecustomer.

8.3ControlofNonconformingProduct
Ensureanynonconformingproductisidentifiedandcontrolledtopreventitsunintendeduseor delivery.Establishadocumentedproceduretodefinethecontrolsandrelatedresponsibilities andauthoritiesfordealingwithnonconformingproduct. Whereapplicable,dealwiththenonconformingproductbyoneormoreofthefollowingways:

Takeactiontoeliminatethedetectednonconformity Authorizeitsuse,release,oracceptancebyconcession Takeactiontoprecludeitsoriginalintendeduseorapplication Takeactionappropriatetotheeffects,orpotentialeffects,ofthenonconformitywhen nonconformingproductisdetectedafterdeliveryorusehasstarted

Maintainrecordsofthenatureofthenonconformity,andanysubsequentactions,(including anyconcessions).Whenthenonconformityiscorrected,reverifyittoshowconformity.

8.4AnalysisofData
Determine,collect,andanalyzeappropriatedatatodemonstratethesuitabilityand effectivenessofthequalitymanagementsystem,aswellas,evaluatewherecontinual improvementoftheeffectivenessofthequalitymanagementsystemcanbemade.Includein theanalysisthedatageneratedbymonitoringandmeasuringactivitiesandfromotherrelevant sources.Analyzethisdatatoprovideinformationon:

Customersatisfaction(see8.2.1) Conformitytoproductrequirements(see8.2.4) Characteristicsandtrendsofprocessesandproducts,includingopportunitiesfor preventiveaction(see8.2.3,8.2.4,and8.5.3) Suppliers(see7.4)


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8.5Improvement
8.5.1ContinualImprovement Continuallyimprovetheeffectivenessofthequalitymanagementsystemthrough:

Qualitypolicy Qualityobjectives Auditresults Analysisofdata Correctiveandpreventiveaction Managementreview

8.5.2CorrectiveAction Takecorrectiveactiontoeliminatethecausesofnonconformitiesandpreventrecurrence. Correctiveactionmustbeappropriatetoeffectsoftheproblem. Establishadocumentedprocedureforcorrectiveactionthatdefinesrequirementsto:


Reviewnonconformities(includingcustomercomplaints) Determinethecausesofnonconformities Evaluatetheneedforactionstopreventrecurrence Determineandimplementingtheneededaction Maintainrecordsoftheresultsoftheactiontaken Reviewtheeffectivenessofcorrectiveactiontaken

8.5.3PreventiveAction Determinetheactiontoeliminatethecausesofpotentialnonconformitiesinordertoprevent theiroccurrence.Ensurepreventiveactionsareappropriatetotheanticipatedeffectsofthe potentialproblem. Establishadocumentedprocedureforpreventiveactiontodefinerequirementsto:


Determinepotentialnonconformitiesandtheircauses Evaluatetheneedforactionstopreventoccurrence Determineandimplementingtheneededaction Maintainrecordsoftheresultsoftheactiontaken Reviewtheeffectivenessofpreventiveactiontaken

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