ISOTS 169492002 标准讲解(206页)

)1/206ISO/TS16949:2002标准讲解)2/206Qualitysystemdocumentationprogression)3/206KeyWords关键词语Shall–mandatoryrequirements应–强制性要求Should–recommendation应该–建议Note–guidanceforunderstanding注–指南以便明白Suchas–forguidance例如–指导性Documentedprocedure–musthavedocumentedsystemprocedure文件化程序–必须有文件化的体系程序)4/206ProcessAnactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.ProcessApproachTheapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoasthe“processapproach”.过程通过使用资源和管理,将输入转化为输出的活动可视为过程。过程方法组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。)5/206质量管理体系的持续改进管理职责测量，分析，改进产品实现资源管理客户满意客户要求产品增值的过程信息传递的途径)6/206质量管理体系8大原则以客户为关注焦点CustomerFocus领导作用Leadership全员参与InvolvementofPeople过程方法ProcessApproach系统化管理SystemApproachtoManagement持续改进ContinualImprovement基于事实的决策方法FactualapproachtoDecisionMaking与供方互利的关系MutuallyBeneficialSupplierRelationships)7/2064Qualitymanagementsystem质量管理体系)8/2064.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisinternationalStandards.Theorganizationshall:a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,4Qualitymanagementsystem4质量管理体系4.1总要求组织应按本标准的要求建立质量管理体系,形成文件,加以实施和保持,并持续改进其有效性.组织应:a)识别质量管理体系所需的过程及其在组织中的应用(见1.2),b)确定这些过程的顺序和相互作用,c)确定为确保这些过程的有效运行和控制所需的准则和方法,)9/2064Qualitymanagementsystem4质量管理体系4.1Generalrequirementsd)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measureandanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisinternationalStandard.4.1总要求d)确保可以获得必要的资源和信息,以支持这些过程的运行和对这些过程的监视,e)监视,测量和分析这些过程f)实施必要的措施,以实现对这些过程策划的结果和对这些过程的持续改进.组织应按本标准的要求管理这些过程.)10/2064Qualitymanagementsystem4质量管理体系Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.Note:Processneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.针对组织所选择的任何影响产品符合要求的外包过程,组织应确保对其实施控制.对此类外包过程的控制应在质量管理体系中加以识别.注:上述质量管理体系所需的过程应当包括与管理活动,资源提供,产品实现和测量有关的过程.)11/2064Qualitymanagementsystem4质量管理体系4.1.1Generalrequirements-SupplementalEnsuringcontroloveroutsourcedprocessesshallnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomersrequirements.NOTESeealso7.4.1and7.4.1.34.1.1总则-补充确保控制外包过程不应免除组织对符合所有客户要求的职责。注：见7.4.1和7.4.1.3)12/2064Qualitymanagementsystem4质量管理体系4.2Documentationrequirements4.2.1GeneralThequalitymanagementsystemdocumentationshallinclude:a)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresrequiredbythisinternationalStandard,d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,ande)recordsrequiredbythisInternationalStandard(see4.2.4)4.2Documentationrequirements4.2.1总则质量管理体系文件应包括:a)形成文件的质量方针和质量目标b)质量手册c)本标准所要求的形成文件的程序d)组织为确保其过程的有效策划,运行和控制所需的文件e)本标准所要求的记录(见4.2.4))13/2064Qualitymanagementsystem4质量管理体系NOTE1:WherethetermdocumentedprocedureappearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2:Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto:a)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnelNOTE3:Thedocumentationcanbeinanyformortypeofmedium.注1:本标准出现“形成文件的程序”之处,即要求建立该程序,形成文件,并加以实施和保持.注2:不同组织的质量管理体系文件的多少于详略程度取决于:a)组织的规模和活动的类型,b)过程及其相互作用的复杂程度,c)人员的能力.注3:文件可采用任何形式或类型的媒体.)14/2064Qualitymanagementsystem4质量管理体系4.2.2QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludes:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2).b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.4.2.2质量手册组织应编制和保持质量手册,质量手册包括:a)质量管理体系的范围,包括任何删减的细节与合理性(见1.2)b)为质量管理体系编制的形成文件的程序或对其引用c)质量管理体系过程之间的相互作用的表述.)15/2064Qualitymanagementsystem4质量管理体系4.2.3ControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolled.Qualityrecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandre-approvedocume