最新卓越管理方案您 可自由编辑 最新卓越管理方案您 可自由编辑 品 质 管 理 质 量 认 证 I A 品 质 管 理 质 量 认 证 I A 4Contextoftheorganization4Contextoftheorganization 4.1Understandingtheorganizationanditscontext4.1Understandingtheorganizationanditscontext SeeISO9001:2015requirements. Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoit spurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintend edresult(s)ofitsqualitymanagementsystem. Theorganizationshallmonitorandreviewinformationabouttheseexternalandinter nalissues. NOTE1Issuescanincludepositiveandnegativefactorsorconditionsforconsideration. NOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisin gfromlegal,technological,petitive,market,cultural,socialandeconomicenvironmen ts,whetherinternational,national,regionalorlocal. NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelate dtovalues,culture,knowledgeandperformanceoftheorganization. 4.2Understandingtheneedsandexpectationsofinterestedparties4.2Understandingtheneedsandexpectationsofinterestedparties SeeISO9001:2015requirements. Duetotheireffectorpotentialeffectontheorganizationsabilitytoconsistentl yprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregul atoryrequirements,theorganizationshalldetermine: a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem; b)therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanag ementsystem. Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartie sandtheirrelevantrequirements. 4.3Determiningthescopeofthequalitymanagementsystem4.3Determiningthescopeofthequalitymanagementsystem SeeISO9001:2015requirements. Theorganizationshalldeterminetheboundariesandapplicabilityofthequalityman agementsystem toestablishitsscope. Whendeterminingthisscope,theorganizationshallconsider: a)theexternalandinternalissuesreferredtoin4.1; b)therequirementsofrelevantinterestedpartiesreferredtoin4.2; c)theproductsandservicesoftheorganization. TheorganizationshallapplyalltherequirementsofthisInternationalStandardift heyareapplicablewithinthedeterminedscopeofitsqualitymanagementsystem. F 中 英 文 对 照 版 4 . 1 理 F 中 英 文 对 照 版 4 . 1 理 Thescopeoftheorganizationsqualitymanagementsystemshallbeavailableandbem aintainedasdocumentedinformation.Thescopeshallstatethetypesofproductsands ervicescovered,andprovidejustificationforanyrequirementofthisInternationa lStandardthattheorganizationdeterminesisnotapplicabletothescopeofitsquali tymanagementsystem. ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdet erminedasnotbeingapplicabledonotaffecttheorganizationsabilityorresponsi bilitytoensuretheconformityofitsproductsandservicesandtheenhancementofcus tomersatisfaction. 4.3.1Determiningthescopeofthequalitymanagementsystem-supplementa l 4.3.1Determiningthescopeofthequalitymanagementsystem-supplementa l Supportingfunctions， whetheron-siteorremote（suchasdesigncentres， corporateheadquarters，anddistributioncentres） ， shallbeincludedinthescopeoftheQualityManagementSystem（QMS）. TheonlypermittedexclusionforthisAutomotiveQMSStandardrelatestoth eproductdesignanddevelopmentrequirementswithinISO9001， Section8.3.Theexclusionshallbejustifiedandmaintainedasdocumented information（seeISO9001，Section7.5）. Permittedexclusionsdonotincludemanufacturingprocessdesign. 4.3.2Customer-specificrequirements4.3.2Customer-specificrequirements Customer-specificrequirementsshallbeevaluatedandincludedinthesco peoftheorganizationsqualitymanagementsystem. 4.4Qualitymanagementsystemanditsprocesses4.4Qualitymanagementsystemanditsprocesses 4.4.14.4.1 SeeISO9001:2015requirements 4.4.1Theorganizationshallestablish,implement,maintainandcontinuallyimprov eaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions ,inaccordancewiththerequirementsofthisInternationalStandard. 4.4.1Theorganizationshallestablish,implement,maintainandcontinuallyimprov eaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions ,inaccordancewiththerequirementsofthisInternationalStandard. 解 组 织 及 其 环 境 解 组 织 及 其 环 境 见 ISO9 001: 2015 的要 求。 组织 应确 定与 其目 标和 战略 方向 相关 并影 响实 Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsys temandtheirapplicationthroughouttheorganization,andshall: a)determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses; b)determinethesequenceandinteractionoftheseprocesses; c)determineandapplythecriteriaandmethods(includingmonitoring,measurements andrelatedperformanceindicators)neededtoensuretheeffectiveoperationandcon troloftheseprocesses; d)determinetheresourcesneededfortheseprocessesandensuretheiravailability; e)assigntheresponsibilitiesandauthoritiesfortheseprocesses; f)addresstherisksandopportunitiesasdeterminedinaccordancewiththerequireme ntsof6.1; g)evaluatetheseprocessesandimplementanychangesneededtoensurethattheseproc essesachievetheirintendedresults; h)improvetheprocessesandthequalitymanagementsystem. 4.4.1.1Conformanceofproductsandprocesses4.4.1.1Conformanceofproductsandprocesses The