ISO9001条文具体说明英文版

TrainingConsultationISO9001：2015StandardDescriptionForTConsultationInc.ForTConsultation2Part1ISO9001&RevisionOverviewsForTConsultation3StepsforRealizationISO9001ImprovementCorrectiveActionsMeasurementForTConsultation4TemplatesforInterestedpartiesInterestedPartiesRequestCorrespondingProcessOutsideCustomerQualityManufactureQualityAssurancePriceR&DDeliverySalesProductionControlSupplierPurchaseOrderProcureGovernmentComplianceLegislationsSafety、ESHConsumerGroupsProductSafetyQualityControlInsideEmployeeSustainedGrowthHumanResourceStockholderInvestmentReturnBusinessPlanLaborUnionSalary&BenefitsHumanResourceForTConsultation5PDCA(Plan-Do-Check-Act)ModelForISO9001ForTConsultation6Risk-basedthinking★Methodology：Norequirementtoformalizetheriskmanagementmethodnortodocumenttheriskmanagementprocess(SWOT,FMEAoranyothermethods).★ScopeofRiskManagement：Includingallqualitymanagementprocesses.★ProcesseswithRisk-basedthinking.ForTConsultation7What(Equipment,Material)InputsKPI(ProcessIndicators)Who(personal,training,know-how,skills)OutputsHow(instructions,procedures)ProcessRiskThinkingTurtleChartRisksThinkingForTConsultation8ContractReviewCustomerFeedbackCoreProcessForTConsultation9RiskP-D-C-A★Chapter4:Requesttheorganizationtodeterminetherisksassociatedwithitsobjectives.─Plan(4.4.1.f)★Chapter5:AskthetopmanagementtocommittoensuringtheimplementationofChapter4.─Plan(5.1.1.d+5.1.2.b)★Chapter6:Requestorganizationstotakeactiontoidentifyrisksandopportunities.─Plan(6.1.1+6.1.2)★Chapter8:Requesttheorganizationtofocusonrisksandopportunitiesintheimplementationprocess.─Do(8.3.3.e+8.3.3.d)★Chapter9:Requestorganizationstomonitor,measure,analyzeandevaluateopportunitiesandrisks.─Check(9.1.3.e+9.3.2.)e★Chapter10:Requesttheorganizationtorespondtochangesandimprovementsinrisk.─Action(10.2.1.e)ForTConsultation10QualityManagementPrinciples—customerfocus;—leadership;—engagementofpeople;—processapproach;—improvement;—evidence-baseddecisionmaking;—relationshipmanagement.ForTConsultation11Documents&RecordsRequested★DocumentsRequired:─Maintaining/AvailabilityisfoundinQMSClauses.─Forexample：4.4.2Totheextentnecessary,theorganizationshall:a)maintaindocumentedinformationtosupporttheoperationofitsprocesses;8.5.1a)theavailabilityofdocumentedinformationthatdefines:1)thecharacteristicsoftheproductstobeproduced,theservicestobeprovided,ortheactivitiestobeperformed;2)theresultstobeachieved★RecordsRequested─Retaining/AmendingisfoundinQMSClauses.─Forexample：8.7.2Theorganizationshallretaindocumentedinformationthat:a)describesthenonconformity;b)….8.2.4ChangestorequirementsforproductsandservicesTheorganizationshallensurethatrelevantdocumentedinformationisamended,andthatrelevantpersonsaremadeawareofthechangedrequirements,……ForTConsultation12ChangeControl6.3Planningofchanges---SystemchangeWhentheorganizationdeterminestheneedofchangestothequalitymanagementsystem,thechangesshallbecarriedoutinaplannedmanner(see4.4).8.3.6Designanddevelopmentchanges---DesignchangeTheorganizationshallidentify,reviewandcontrolchangesmadeduring,orsubsequentto,thedesignanddevelopmentofproductsandservices,totheextentnecessarytoensurethatthereisnoadverseimpactonconformitytorequirements.8.5.6Controlofchanges---EngineeringchangeTheorganizationshallreviewandcontrolchangesforproductionorserviceprovision,totheextentnecessarytoensurecontinuingconformitywithrequirements.ForTConsultation13OrganizationalknowledgeRequirementsregardingorganizationalknowledgewereintroducedforthepurposeof:a)safeguardingtheorganizationfromlossofknowledge,e.g.—throughstaffturnover;—failuretocaptureandshareinformation;b)encouragingtheorganizationtoacquireknowledge,e.g.—learningfromexperience;—mentoring;—benchmarking.★ForTConsultation14Revisionbackground■ThecommitteeresponsibleforthisdocumentisTechnicalCommitteeISO/TC176/SC2,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems.■AllISOinternationalstandardsshouldbereviewedevery5-8yearstoassesstheirapplicabilityandsuitability.■TheISO9000familyhasbeenrevisedseveraltimessince1987.ForTConsultation15WORKDRAFTCOMMITTEEDRAFTDRAFTINTERNATIONALSTANDARDFINALDRAFTINTERNATIONALSTANDARDINTERNATIONALSTANDARDWDISFDISDISCDRevisionProcessforISOStandardForTConsultation16MajordifferencesinterminologyForTConsultation17Part2UnderstandingthenewversionForTConsultation18ReadingGuidance★Purpletext：Newrequirementsforthe2015versionascomparingtothe2008versionanditsintentsarehighlightedattherightside.★Greentext：Documentedinformationisrequired.★Blacktext：Nokeychangesforthe2015versioncomparedtothe2008version，andnohighlightsattherightside.ForTConsultation19GuidanceforReading★InthisInternationalStandard,thefollowingverbalformsareused:—“shall”indicatesarequirement;—“should”indicatesarecommendation;—“may”indicatesapermission;—“can”indicatesapossibilityoracapability.★Informationmarkedas“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.ForTConsultation20ISO9001:2015ClausesHighlightsDocumentedInformation4Contextoftheorganization4.1UnderstandingtheorganizationanditscontextTheorganizations