ISOS：质量管理体系标准讲解

ISO/TS16949:2002标准讲解（中英文对照版）因涉及ISO的版权问题，故仅限家园范围使用。请勿扩散。1Qualitysystemdocumentationprogression2KeyWords

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3

ProcessAnactivityusingresources,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”。45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MutuallyBeneficialSupplierRelationships64Qualitymanagementsystem

质量管理体系74.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisinternationalStandards.Theorganizationshall:a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,4Qualitymanagementsystem

4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,8

4Qualitymanagementsystem

4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.9

4Qualitymanagementsystem

4质量管理体系Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshall

ensurecontroloversuchprocesses.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.104Qualitymanagementsystem4质质量管理体体系4.1.1Generalrequirements-SupplementalEnsuringcontroloveroutsourcedprocessesshallnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomersrequirements.NOTESeealso7.4.1and4.1.1总则-补充充确保控制外外包过程不应免除组织对对符合所有有客户要求求的职责。。注：见7.4.1和和114Qualitymanagementsystem4质质量管理体体系4.2Documentationrequirements4.2.1GeneralThequalitymanagementsystemdocumentationshallinclude:a)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresrequiredbythisinternationalStandard,d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,ande)recordsrequiredbythisInternationalStandard(see4.2.4)4.2Documentationrequirements4.2.1总则质量管理体体系文件应包括:a)形成成文件的质质量方针和和质量目标标b)质量量手册c)本标标准所要求求的形成文文件的程序序d)组织织为确保其其过程的有有效策划,运行行和控制制所需的文文件e)本标标准所要求求的记录(见4.2.4)124Qualitymanagementsystem4质质量管理体体系NOTE1:Wheretheterm<documentedprocedure>appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2:Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto:a)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnelNOTE3:Thedocumentationcanbeinanyformortypeofmedium.注1:本本标准出现““形成文件的的程序”之处处,即要求建建立该程序,形成文件,并加以实施施和保持.注2:不不同组织的质质量管理体系系文件的多少少于详略程度度取决于:a)组织的的规模和活动动的类型,b)过程及及其相互作用用的复杂程度度,c)人员的的能力.注3:文文件可采用任任何形式或类类型的媒体.134Qualitymanagementsystem4质量量管理体系4.2.2QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludes:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2).b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.4.2.2质质量手册组织应编制和保持质质量手册,质质量手册包括括:a)质量管管理体系的范范围,包括任任何删减的细细节与合理性性(见1.2)b)为质量量管理体系编编制的形成文文件的程序或或对其引用c)质量管管理体系过程程之间的相互互作用的表述述.144Qualitymanagementsystem4质量量管理体系4.2.3ControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolled.Qualityrecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandre-approvedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,4.2.3文文件控制质量管理体系系所要求的文文件应予以控制.记记录是一种特特殊类型的文文件,应按照照4.2.4的要求进行行控制.应编制形成文件件的程序,以以规定以下方方面所需的控控制:a)文件发发布前得到批批准,以确保保文件是充分分与适宜的,b)必要时时对文件进行行评审与更新新,并再次批批准,c)确保文文件的更改和和现行修订状状态得到识别别,154Qualitymanagementsystem4质量量管理体系d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse.e)toensurethatdocumentsremainlegibleandreadilyidentifiable.f)toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocument,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.d)确保在在使用处可获获得适用文件件的有关版本本e)确保文文件保持清晰晰,易于识别别,f)确保外外来文件得到到识别,并控控制其分发,g)防止作作废文件的非非预期使用,若因任何原原因而保留作作废文件时,对这些文件件进行适当的的标识.164Qualitymanagementsystem4质量量管理体系EngineeringspecificationsTheorganizationshallhaveaprocesstoassurethetimelyreview,distributionandimplementationofallcustomerengineeringstandards/specificationsandchangesbasedoncustomerrequiredschedule.Timelyreviewshouldbeassoonaspossible,andshallnotexceedtwoworkingweeks.Theorganizationshallmaintainarecordofthedateonwhicheachchangeisimplementedinproduction.Implementationshallincludeupdatesdocuments.工程规规范组织应有一过程以确确保对所有客客户的工程标标准/规范和和更改和在客客户要求的时时间表的基础础上进行及时时的评审，发发放和实施。。进行及时的的评审应该尽尽早，并且不不应超过2个工作作周。组织应保持在生产中中的每一个更更改实施日期期的记录。实实施应包括更新文件件。174Qualitymanagementsystem4质量量管理体系NOTE:Achangeinthesestandards/specificationsrequiresanupdatedrecordofcustomerproductionpartapprovalwhenthesespecificationsarereferencedonthedesignrecordoriftheyaffectdocumentsofproductionpartapprovalprocess,suchascontrolplan,FMEAs,etc.注：当这些规规范指向设计计记录或他们们影响到生产产零件审批过过程，诸如控控制计划，FMEA等时时，这些标准准/规范中的的每一个更改改都要求客户户生产零件审审批的更新记记录。184Qualitymanagementsystem4质量量管理体系4.2.4ControlofrecordsRecordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.4.2.4记记录控控制应建立并并保持持记录录,以以提供供符合合要求求和质质量管管理体体系有有效运运行的的证据据.记记录应应保持持清晰晰,易易于识识别和和检索索.应编制形形成文文件的的程序序,以以规定定记录录的标标识,贮存存,保保护,检索索,保保存期期限和和处置置所需需的控控制.194Qualitymanagementsystem4质质量管管理体体系NOTE1:““Disposition””aboveincludesdisposal.NOTE2:““Records””alsoincludecustomer-specifiedrecords.RecordsretentionThecontrolofrecordsshallsatisfyregulatoryandcustomerrequirement.注1：：上述述的““处置置”包包括处处理。。注2：：“记记录””也包包括客客户指指定的的记录录。记记录的的保持持记录控控制应满足法法规和和客户户要求求。205Managementresponsibility管理层层职责责215Managementresponsibility5管管理层层职责责5.1ManagementcommitmentTopmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby:a)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,b)establishingthequalitypolicy,c)ensuringthatqualityobjectivesareestablished,d)conductingmanagementreviews,ande)ensuringtheavailabilityofresources.5.1管管理理承承诺诺最高高管管理理者者应通过过以以下下活活动动,对对其其建建立立,实实施施质质量量管管理理体体系系并并持持续续改改进进其其有有效效性性的的承承诺诺提提供供证证据据:a)向向组组织织传传达达满满足足顾顾客客和和法法律律法法规规要要求求的的重重要要性性,b)制制定定质质量量方方针针,c)确确保保质质量量目目标标的的制制定定,d)进进行行管管理理评评审审,e)确确保保资资源源的的获获得得,225Managementresponsibility5管管理理层层职职责责5.1.1ProcessefficiencyTopmanagementshallreviewtheproductrealizationprocessesandthesupportprocessestoassuretheireffectivenessandefficiency.5.1.1过过程程有有效效性性最高高管管理理层层应评审审产产品品的的实实现现过过程程和和支支持持过过程程以以确确保保它它们们的的有有效效性性和和效效率率。。235Managementresponsibility5管管理理层层职职责责5.2CustomerfocusTopmanagementshallensurethatcustomerrequirementsaredeterminedandfulfilledwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).5.2以以顾顾客客为为关关注注焦焦点点最高高管管理理者者应以增增强强顾顾客客满满意意为为目目的的,确确保保顾顾客客的的要要求求得得到到确确定定并并予予以以满满足足(见见7.2.1和和8.2.1).245Managementresponsibility5管管理理层层职职责责5.3QualitypolicyTopmanagementshallensurethatthequalitypolicy.a)isappropriatetothepurposeoftheorganization,b)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,c)providesaframeworkforestablishingandreviewingqualityobjectives,d)iscommunicatedandunderstoodwithintheorganization,ande)isreviewedforcontinuingsuitability.5.3质质量方方针最高管理理者应确保质量量方针:a)与与组织的的宗旨相相适应,b)包包括对满满足要求求和持续续改进质质量管理理体系有有效性的的承诺,c)提提供制定定和评审审质量目目标的框框架,d)在在组织内内得到沟沟通和理理解e)在在持续适适宜性方方面得到到评审.255Managementresponsibility5管管理层层职责5.4Planning5.4.1QualityobjectivesTopmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct(see7.1)areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.5.4策策划5.4.1质质量目标标最高管理理者应确保在组组织的相相关职能能和层次次上建立立质量目目标,质质量目标标包括满满足产品品要求所所需的内内容(见见7.1).质质量目标标应是可测量的,并与质量方方针保持一致致.265Managementresponsibility5管理理层职责Qualityobjectives-supplementalTopmanagementshalldefinequalityobjectivesandmeasurementsthatshallbeincludedinthebusinessplanandusedtodeploythequalitypolicy.NOTE:Qualityobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod.质量目目标-补补充最高管理层应确定质量目标标和度量指标标，应包含于业务计计划和用来展展开质量方针针。注：质量目标标中应该注明明客户的期望望，并在所定定期限内可以以达到。275Managementresponsibility5管理理层职责5.4.2QualitymanagementsystemplanningTopmanagementshallensurethat:a)theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,andb)theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.5.4.2质质量管理体体系策划最高管理者应确保:a)对质量量管理体系进进行策划,以以满足质量目目标以及4.1的要求,b)在对质质量管理体系系的变更进行行策划和实施施时,保持质质量管理体系系的完整性.285Managementresponsibility5管理理层职责5.5Responsibility,authorityandcommunication5.5.1ResponsibilityandauthorityTopmanagementshallensurethattheresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization.5.5职责责,权限与沟沟通5.5.1职职责和权限限最高管理者应确保组织内的的职责,权限限得到规定和和沟通.295Managementresponsibility5管理理层职责ResponsibilityforQualityManagerswithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichdonotconformtorequirements.Personnelresponsibleforproductqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems.Productionoperationsacrossallshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityfor，ensuringproductquality.质量职职责对纠正措施赋赋有职责和权权限的管理者者应被及时通知不不符合要求的的产品或过程程。赋有产品质量量职责的人员员应有权限停止生生产以纠正质质量问题。所有班次的生生产运作应有人员看管，，或委派相关关职责人员以以确保产品质质量。305Managementresponsibility5管理理层职责5.5.2ManagementrepresentativeTopmanagementshallappointamemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes:a)ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,b)reportingtotopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,andc)ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.NOTE:Theresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.5.5.2管管理者代表表最高管理者应指定一名管理理者,无论该该成员在其它它方面的职责责如何,应具有以下方面面的职责和权权限:a)确保质质量管理体系系所需的过程程得到建立,实施和保持持,b)向最高高管理者报告告质量管理体体系的业绩和和任何改进的的需求,c)确保在在整个组织内内提高满足顾顾客要求的意意识.注:管理者者代表的职责责可包括与质质量管理体系系有关事宜的的外部联络.315Managementresponsibility5管理理层职责CustomerrepresentativeTopmanagementshalldesignatepersonnelwithresponsibilityandauthoritytoensurethecustomerrequirementsareaddressed.Thisincludesselectionofspecialcharacteristics,settingqualityobjectivesandrelatedtraining,correctiveandpreventiveactions,productdesignanddevelopment.客户户代表最高管理层应指派人员拥有有职责和权限限以确保满足足客户要求。。包括选择特特殊特性、建建立质量目标标和相关的培培训、纠正和和预防措施、、产品设计和和开发。325Managementresponsibility5管理理层职责5.5.3InternalcommunicationTopmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplacesregardingtheeffectivenessofthequalitymanagementsystem.5.5.3内内部沟通最高管理者应确保在组织内内建立适当的的沟通过程,并确保对质质量管理体系系的有效性进进行沟通.335Managementresponsibility5管理理层职责5.6Managementreview5.6.1GeneralTopmanagementshallreviewtheorganization'squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitability,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives.Recordsfrommanagementreviewsshallbemaintained(see4.2.4)5.6管理理评审5.6.1总总则最高管理者应按策划的时间间间隔评审质质量管理体系系,以确保其其持续的适宜宜性,充分性性和有效性.评审应包括评价质量量管理体系改改进的机会和和变更的需要要,包括质量量方针和质量量目标..应保持管理评评审的记录录(见4.2.4).345Managementresponsibility5管管理层职责责QualitymanagementsystemperformanceThesereviewsshallincludeallrequirementsofthequalitymanagementsystemanditsperformancetrendsasanessentialpartofthecontinualimprovementprocess.Partofthemanagementreviewshallbethemonitoringofqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality(see8.4.1and8.5.1)质质量管理体体系绩效这些评审应包括质量管管理体系的的所有要求求，并且将将它的绩效效趋势作为为持续改进进过程的实实质部分。。管理评审的的其中部分分应是质量目标标的监控，，定期报告告和评价不不良质量成成本。355Managementresponsibility5管管理层职责责Theseresultsshallberecordedtoprovide,asaminimum,evidenceoftheachievementof:-thequalityobjectivesspecifiedinthebusinessplan,and-customersatisfactionwithproductsupplied.这些结果应被记录，至至少可提供供作为证据据达到：-业务务计划中规规定的质量量目标，和和-客户户对产品提提供的满意意度。365Managementresponsibility5管管理层职责责5.6.2ReviewinputTheinputtomanagementreviewshallincludeinformationon:a)resultsofaudits,b)customerfeedback,c)processperformanceandproductconformity,d)statusofpreventiveandcorrectiveactions,e)follow-upactionsfrompreviousmanagementreviews,f)plannedchangesthatcouldaffectthequalitymanagementsystem,andg)recommendationsforimprovement.5.6.2评审输输入管理评审的的输入应包括以下方方面的信息息:a)审核核结果b)顾客客反馈c)过程程的业绩和和产品的符符合性d)预防防和纠正措措施的状况况e)以往往管理评审审的跟踪措措施f)可能能影响质量量管理体系系的变更g)改进进的建议375Managementresponsibility5管管理层职责责Reviewinput-SupplementalInputtomanagementreviewshallincludeananalysisofactualandpotentialfield-failuresandtheirimpactonquality,safety,ortheenvironment.评评审输入-补充充管理评审的的输入应包括对实际际和潜在使使用失效的的分析以及及它们对质质量，安全全或环境的的影响。385Managementresponsibility5管管理层职责责5.6.3ReviewoutputTheoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto:a)improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses,b)improvementofproductrelatedtocustomerrequirements,andc)resourceneeds.5.6.3评审输输出管理评审的的输出应包括与以下下方面有关关的任何决决定和措施施:a)质量量管理体系系及其过程程有效性的的改进b)与顾顾客要求有有关的产品品的改进c)资源源需求.396Resourcemanagement资源源管管理理406Resourcemanagement6资资源源管管理理6.1ProvisionofresourcesTheorganizationshalldetermineandprovidetheresourcesneeded:a)toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,andb)toenhancecustomersatisfactionbymeetingcustomerrequirements.6.1资资源源提提供供组织织应确定定并并提提供供以以下下方方面面所所需需的的资资源源:a)实实施施,保保持持质质量量管管理理体体系系并并持持续续改改进进其其有有效效性性,b)通通过过满满足足顾顾客客要要求求,增增强强顾顾客客满满意意.416Resourcemanagement6资资源源管管理理6.2Humanresources6.2.1GeneralPersonnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience.6.2人人力力资资源源6.2.1总总则则基于于适适当当的的教教育育,培培训训,技技能能和和经经验验,从从事事影影响响产产品品质质量量工工作作的的人人员员应是能能够够胜胜任任的的.426Resourcemanagement6资资源源管管理理6.2.2Competence,awarenessandtrainingTheorganizationshall:a)determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality,b)providetrainingortakeotheractionstosatisfytheseneeds,c)evaluatetheeffectivenessoftheactionstaken,d)ensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,ande)maintainappropriaterecordsofeducation,training,skillsandexperience.6.2.2能能力力,意意识识和和培培训训组织织应:a)确确定定从从事事影影响响产产品品质质量量工工作作的的人人员员所所必必要要的的能能力力,b)提提供供培培训训或或采采取取其其它它措措施施以以满满足足这这些些需需求求,c)评评价价所所采采取取措措施施的的有有效效性性,d)确确保保员员工工认认识识到到所所从从事事活活动动的的相相关关性性和和重重要要性性,以以及及如如何何为为实实现现质质量量目目标标作作出出贡贡献献,e)保保持持教教育育,培培训训,技技能能和和经经验验的的适适当当记记录录.436Resourcemanagement6资资源源管管理理ProductdesignskillsTheorganizationshallensurethatpersonnelwithproductdesignresponsibilityarecompetenttoachievedesignrequirementsandareskilledinapplicabletoolsandtechniques.Applicabletoolsandtechniquesshallbeidentifiedbytheorganization.产产品设计技术术组织应确保负责产品品设计的人员员有能力完成成设计要求并并熟练使用适适用的工具和和技巧。适用的工具和和技巧应被组织识别。446Resourcemanagemnet6资资源管理TrainingTheorganizationshallestablishandmaintaindocumentedproceduresforidentifyingtrainingneedsandachievingcompetenceofallpersonnelperformingactivitiesaffectingproductquality.Personnelperformingspecificassignedtasksshallbequalified，asrequiredwithparticularattentiontothesatisfactionofcustomerrequirements.培培训组织应建立和保持文文件化程序以以识别培训需需求和影响产产品质量的所所有员工具备备能力。执行行特殊任务的的员工应具备资格，特特殊关注按照照满足客户要要求。456Resourcemanagemnet6资资源管理TrainingNOTE1Thisappliestoallemployeesaffectingqualityatalllevelsoftheorganization.NOTE2Anexampleofthecustomerspecificrequirementsistheapplicationofdigitizedmathematicallybaseddata.培训训注1适用于于组织各个阶阶层的对质量量有影响的所所有员工。注2客户特特殊要求的一一个例子是数数字数据的应应用。466Resourcemanagemnet6资资源管理在在职培训组织应向员工，包括括合同或中介介人员提供关关于影响产品品质量的新的的或修改过的的作业的在职职培训。对质质量有影响的的员工，应被通知关于不不符合质量要要求对客户的的后果。TrainingonthejobTheorganizationshallprovideonthejobtrainingforpersonnelinanynewormodifiedjobaffectingproductqualityincludingcontractoragencypersonnel.Personnelwhoseworkcanaffectqualityshallbeinformedabouttheconsequencestothecustomerofnon-conformitytoqualityrequirements.476Resourcemanagemnet6资资源管理员工的的积极性和推推动组织应具备一过程以以激励员工达达成质量目标标，做到持续续改进，并创创造一个促进进革新的环境境。这个过程程应包括整个组织织对质量和技技术意识的提提升。EmployeemotivationandempowermentTheorganizationshallhaveaprocesstomotivateemployeestoachievequalityobjectives,tomakecontinualimprovements,andtocreateanenvironmenttopromoteinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.486Resourcemanagemnet6资资源管理员工的的积极性和推推动组织应具备一测量过过程以保证其其人员了解他他们活动的恰恰当性和重要要性及他们如如何有助于达达到质量目标标(见6.2.2d)。EmployeemotivationandempowermentTheorganizationshallhaveaprocesstomeasuretheextenttowhichitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives(see6.2.2d).496Resourcemanagement6资资源管理6.3InfrastructureTheorganizationshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicablea)buildings,workspaceandassociatedutilities,b)processequipment,(bothhardwareandsoftware),andc)supportingservices(suchastransportorcommunication).6.3基基础设设施组织应确定,提供供并维维护为为达到到产品品符合合要求求所需需的基基础设设施.适适用时时,基基础设设施包包括:a)建建筑筑物,工作作场所所和相相关的的设施施b)过过程程设备备(硬硬件和和软件件)c)支支持持性服服务(如运运输或或通讯讯).506Resourcemanagemnet6资资源管管理6.3.1工工厂，，设施施和设设备策策划组织应采用多多方论论证方方式(见)以以开开发工工厂，，设施施和设设备的的计划划。工工厂的的布局局应优化材材料的的运输输，搬搬运及及增值值使用用空间间，并并应方便材材料的的同步步流动动。应开发和和实施施方法法来评评估和和监控控现有有运作作的有有效性性。6.3.1Plant,facilityandequipmentplanningTheorganizationshalluseamultidisciplinaryapproach(see)fordevelopingplant,facilityandequipmentplans.Plantlayoutsshalloptimizematerialtravel,handlingandvalue-addeduseoffloorspace,andshallfacilitatesynchronousmaterialflow.Methodsshallbedevelopedandimplementedtoevaluateandmonitortheeffectivenessofexistingoperations.516Resourcemanagemnet6资资源管管理6.3.1工工厂，，设施施和设设备策策划注这这些要要求应应该关关注于于精益益生产产原则则及与与质量量管理理体系系有效效性的的连系系。6.3.1Plant,facilityandequipmentplanningNOTETheserequirementsshouldfocusonleanmanufacturingprinciplesandthelinktotheeffectivenessofthequalitymanagementsystem.526Resourcemanagemnet6资资源管管理6.3.2ContingencyplansTheorganizationshallpreparecontingencyplanstosatisfythecustomerrequirementsintheeventofanemergencysuchasutilityinterruptions,labourshortages,keyequipmentfailure,andfieldreturns.6.3.2应应急急计划划组织应准备应应急计计划以以在紧紧急情情况下下，诸诸如供供应中中断，，劳动动力短短缺，，关键键设备备故障障和市市场退退回时时，满满足客客户要要求。。536Resourcemanagement6资资源源管理理6.4WorkenvironmentTheorganizationshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements.6.4工工作环环境组织应确定并并管理理为达达到产产品符符合要要求所所需的的工作作环境境.546Resourcemanagement6资资源管管理6.4.1PersonnelsafetytoachieveproductqualityProductsafetyandmeanstominimizepotentialriskstoemployeesshallbeaddressedbytheorganization,especiallyindesignanddevelopmentprocessandinthemanufacturingprocessactivities.6.4.1人人员安安全以以达到到产品品质量量产品安安全性性和降降低对对员工工的潜潜在风风险的的方法法应由组织织提出出，尤尤其是是设计计和开开发过过程及及生产产过程程活动动。556Resourcemanagemnet6资资源管管理6.4.2CleanlinessofpremisesTheorganizationshallmaintainitspremisesinastateoforder，cleanlinessandrepairconsistentwiththeproductandmanufacturingprocessneeds.6.4.2厂区的的清洁组织应保持厂区与与产品一致致的有序、、清洁，并并按产品和和制造过程程需求进行行适当的维维护。567ProductRealization产品实现577productrealization7产产品实实现7.1PlanningofproductrealizationTheorganizationshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesofthequalitymanagementsystem(see4.1).a)qualityobjectivesandrequirementsfortheproduct;b)theneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproduct;c)requiredverification,validation,monitoring,inspectionandtestactivitiesspecifictotheproductandthecriteriaforproductacceptance;d)recordsneededtoprovideevidencethattherealizationprocessesandresultingproductmeetrequirements(see4.2.4).Theoutputofthisplanningshallbeinaformsuitablefortheorganization’’smethodofoperations.7.1产产品实现的的策划组织应策划和开发发产品实现现所需的过过程.产产品实现的的策划应与质量管理理体系其它它过程的要要求相一致致(见4.1).a)产品品的质量目目标和要求求b)针对对产品确定定过程,文文件和资源源的需求c)产品品所要求的的验证,确确认,监视视,检验和和试验活动动,以及产产品接收准准则d)为实实现过程及及其产品满满足要求提提供证据所所需的记录录(见4.2.4)策划的输出出形式应适用于组织织的运作方方式.587productrealization7产产品实实现7.1PlanningofproductrealizationNOTE1:Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingtheproductrealizationprocesses)andtheresourcestobeappliedtoaspecificproduct,projectorcontract,canbereferredtoasaqualityplan.NOTE2:Theorganizationmayalsoapplytherequirementsgivenin7.3tothedevelopmentofproductrealizati