ISO/TS16949:2002標(biāo)準(zhǔn)講解（中英文對(duì)照版）因涉及ISO的版權(quán)問(wèn)題，故僅限家園范圍使用。請(qǐng)勿擴(kuò)散。1Qualitysystemdocumentationprogression2KeyWords

關(guān)鍵詞語(yǔ)Shall–mandatoryrequirements應(yīng)–強(qiáng)制性要求Should–recommendation應(yīng)該–建議Note–guidanceforunderstanding注–指南以便明白Suchas–forguidance例如–指導(dǎo)性Documentedprocedure–musthavedocumentedsystemprocedure文件化程序–必須有文件化的體系程序3

ProcessAnactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.ProcessApproachTheapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoasthe“processapproach”.過(guò)程通過(guò)使用資源和管理,將輸入轉(zhuǎn)化為輸出的活動(dòng)可視為過(guò)程。過(guò)程方法組織內(nèi)諸過(guò)程的系統(tǒng)的應(yīng)用，連同這些過(guò)程的識(shí)別和相互作用及其管理，可稱之為“過(guò)程方法”。45質(zhì)量管理體系8大原則

以客戶為關(guān)注焦點(diǎn)CustomerFocus領(lǐng)導(dǎo)作用Leadership全員參與InvolvementofPeople過(guò)程方法ProcessApproach系統(tǒng)化管理SystemApproachtoManagement持續(xù)改進(jìn)ContinualImprovement

基于事實(shí)的決策方法FactualapproachtoDecisionMaking與供方互利的關(guān)系MutuallyBeneficialSupplierRelationships64Qualitymanagementsystem

質(zhì)量管理體系74.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisinternationalStandards.Theorganizationshall:a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,4Qualitymanagementsystem

4質(zhì)量管理體系4.1總要求組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系,形成文件,加以實(shí)施和保持,并持續(xù)改進(jìn)其有效性.組織應(yīng):a)識(shí)別質(zhì)量管理體系所需的過(guò)程及其在組織中的應(yīng)用(見1.2),b)確定這些過(guò)程的順序和相互作用,c)確定為確保這些過(guò)程的有效運(yùn)行和控制所需的準(zhǔn)則和方法,8

4Qualitymanagementsystem

4質(zhì)量管理體系4.1Generalrequirementsd)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measureandanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisinternationalStandard.4.1總要求d)確?？梢垣@得必要的資源和信息,以支持這些過(guò)程的運(yùn)行和對(duì)這些過(guò)程的監(jiān)視,e)監(jiān)視,測(cè)量和分析這些過(guò)程f)實(shí)施必要的措施,以實(shí)現(xiàn)對(duì)這些過(guò)程策劃的結(jié)果和對(duì)這些過(guò)程的持續(xù)改進(jìn).組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過(guò)程.9

4Qualitymanagementsystem

4質(zhì)量管理體系Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshall

ensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.Note:Processneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.針對(duì)組織所選擇的任何影響產(chǎn)品符合要求的外包過(guò)程,組織應(yīng)確保對(duì)其實(shí)施控制.對(duì)此類外包過(guò)程的控制應(yīng)在質(zhì)量管理體系中加以識(shí)別.注:上述質(zhì)量管理體系所需的過(guò)程應(yīng)當(dāng)包括與管理活動(dòng),資源提供,產(chǎn)品實(shí)現(xiàn)和測(cè)量有關(guān)的過(guò)程.104Qualitymanagementsystem4質(zhì)質(zhì)量管理體體系4.1.1Generalrequirements-SupplementalEnsuringcontroloveroutsourcedprocessesshallnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomersrequirements.NOTESeealso7.4.1and4.1.1總則-補(bǔ)充充確保控制外外包過(guò)程不應(yīng)免除組織對(duì)對(duì)符合所有有客戶要求求的職責(zé)。。注：見7.4.1和和114Qualitymanagementsystem4質(zhì)質(zhì)量管理體體系4.2Documentationrequirements4.2.1GeneralThequalitymanagementsystemdocumentationshallinclude:a)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresrequiredbythisinternationalStandard,d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,ande)recordsrequiredbythisInternationalStandard(see4.2.4)4.2Documentationrequirements4.2.1總則質(zhì)量管理體體系文件應(yīng)包括:a)形成成文件的質(zhì)質(zhì)量方針和和質(zhì)量目標(biāo)標(biāo)b)質(zhì)量量手冊(cè)c)本標(biāo)標(biāo)準(zhǔn)所要求求的形成文文件的程序序d)組織織為確保其其過(guò)程的有有效策劃,運(yùn)行行和控制制所需的文文件e)本標(biāo)標(biāo)準(zhǔn)所要求求的記錄(見4.2.4)124Qualitymanagementsystem4質(zhì)質(zhì)量管理體體系NOTE1:Wheretheterm<documentedprocedure>appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2:Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto:a)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnelNOTE3:Thedocumentationcanbeinanyformortypeofmedium.注1:本本標(biāo)準(zhǔn)出現(xiàn)““形成文件的的程序”之處處,即要求建建立該程序,形成文件,并加以實(shí)施施和保持.注2:不不同組織的質(zhì)質(zhì)量管理體系系文件的多少少于詳略程度度取決于:a)組織的的規(guī)模和活動(dòng)動(dòng)的類型,b)過(guò)程及及其相互作用用的復(fù)雜程度度,c)人員的的能力.注3:文文件可采用任任何形式或類類型的媒體.134Qualitymanagementsystem4質(zhì)量量管理體系4.2.2QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludes:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see1.2).b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.4.2.2質(zhì)質(zhì)量手冊(cè)組織應(yīng)編制和保持質(zhì)質(zhì)量手冊(cè),質(zhì)質(zhì)量手冊(cè)包括括:a)質(zhì)量管管理體系的范范圍,包括任任何刪減的細(xì)細(xì)節(jié)與合理性性(見1.2)b)為質(zhì)量量管理體系編編制的形成文文件的程序或或?qū)ζ湟胏)質(zhì)量管管理體系過(guò)程程之間的相互互作用的表述述.144Qualitymanagementsystem4質(zhì)量量管理體系4.2.3ControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolled.Qualityrecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivenin4.2.4.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandre-approvedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,4.2.3文文件控制質(zhì)量管理體系系所要求的文文件應(yīng)予以控制.記記錄是一種特特殊類型的文文件,應(yīng)按照照4.2.4的要求進(jìn)行行控制.應(yīng)編制形成文件件的程序,以以規(guī)定以下方方面所需的控控制:a)文件發(fā)發(fā)布前得到批批準(zhǔn),以確保保文件是充分分與適宜的,b)必要時(shí)時(shí)對(duì)文件進(jìn)行行評(píng)審與更新新,并再次批批準(zhǔn),c)確保文文件的更改和和現(xiàn)行修訂狀狀態(tài)得到識(shí)別別,154Qualitymanagementsystem4質(zhì)量量管理體系d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse.e)toensurethatdocumentsremainlegibleandreadilyidentifiable.f)toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocument,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.d)確保在在使用處可獲獲得適用文件件的有關(guān)版本本e)確保文文件保持清晰晰,易于識(shí)別別,f)確保外外來(lái)文件得到到識(shí)別,并控控制其分發(fā),g)防止作作廢文件的非非預(yù)期使用,若因任何原原因而保留作作廢文件時(shí),對(duì)這些文件件進(jìn)行適當(dāng)?shù)牡臉?biāo)識(shí).164Qualitymanagementsystem4質(zhì)量量管理體系EngineeringspecificationsTheorganizationshallhaveaprocesstoassurethetimelyreview,distributionandimplementationofallcustomerengineeringstandards/specificationsandchangesbasedoncustomerrequiredschedule.Timelyreviewshouldbeassoonaspossible,andshallnotexceedtwoworkingweeks.Theorganizationshallmaintainarecordofthedateonwhicheachchangeisimplementedinproduction.Implementationshallincludeupdatesdocuments.工程規(guī)規(guī)范組織應(yīng)有一過(guò)程以確確保對(duì)所有客客戶的工程標(biāo)標(biāo)準(zhǔn)/規(guī)范和和更改和在客客戶要求的時(shí)時(shí)間表的基礎(chǔ)礎(chǔ)上進(jìn)行及時(shí)時(shí)的評(píng)審，發(fā)發(fā)放和實(shí)施。。進(jìn)行及時(shí)的的評(píng)審應(yīng)該盡盡早，并且不不應(yīng)超過(guò)2個(gè)工作作周。組織應(yīng)保持在生產(chǎn)中中的每一個(gè)更更改實(shí)施日期期的記錄。實(shí)實(shí)施應(yīng)包括更新文件件。174Qualitymanagementsystem4質(zhì)量量管理體系NOTE:Achangeinthesestandards/specificationsrequiresanupdatedrecordofcustomerproductionpartapprovalwhenthesespecificationsarereferencedonthedesignrecordoriftheyaffectdocumentsofproductionpartapprovalprocess,suchascontrolplan,FMEAs,etc.注：當(dāng)這些規(guī)規(guī)范指向設(shè)計(jì)計(jì)記錄或他們們影響到生產(chǎn)產(chǎn)零件審批過(guò)過(guò)程，諸如控控制計(jì)劃，F(xiàn)MEA等時(shí)時(shí)，這些標(biāo)準(zhǔn)準(zhǔn)/規(guī)范中的的每一個(gè)更改改都要求客戶戶生產(chǎn)零件審審批的更新記記錄。184Qualitymanagementsystem4質(zhì)量量管理體系4.2.4ControlofrecordsRecordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.4.2.4記記錄控控制應(yīng)建立并并保持持記錄錄,以以提供供符合合要求求和質(zhì)質(zhì)量管管理體體系有有效運(yùn)運(yùn)行的的證據(jù)據(jù).記記錄應(yīng)應(yīng)保持持清晰晰,易易于識(shí)識(shí)別和和檢索索.應(yīng)編制形形成文文件的的程序序,以以規(guī)定定記錄錄的標(biāo)標(biāo)識(shí),貯存存,保保護(hù),檢索索,保保存期期限和和處置置所需需的控控制.194Qualitymanagementsystem4質(zhì)質(zhì)量管管理體體系NOTE1:““Disposition””aboveincludesdisposal.NOTE2:““Records””alsoincludecustomer-specifiedrecords.RecordsretentionThecontrolofrecordsshallsatisfyregulatoryandcustomerrequirement.注1：：上述述的““處置置”包包括處處理。。注2：：“記記錄””也包包括客客戶指指定的的記錄錄。記記錄的的保持持記錄控控制應(yīng)滿足法法規(guī)和和客戶戶要求求。205Managementresponsibility管理層層職責(zé)責(zé)215Managementresponsibility5管管理層層職責(zé)責(zé)5.1ManagementcommitmentTopmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby:a)communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,b)establishingthequalitypolicy,c)ensuringthatqualityobjectivesareestablished,d)conductingmanagementreviews,ande)ensuringtheavailabilityofresources.5.1管管理理承承諾諾最高高管管理理者者應(yīng)通過(guò)過(guò)以以下下活活動(dòng)動(dòng),對(duì)對(duì)其其建建立立,實(shí)實(shí)施施質(zhì)質(zhì)量量管管理理體體系系并并持持續(xù)續(xù)改改進(jìn)進(jìn)其其有有效效性性的的承承諾諾提提供供證證據(jù)據(jù):a)向向組組織織傳傳達(dá)達(dá)滿滿足足顧顧客客和和法法律律法法規(guī)規(guī)要要求求的的重重要要性性,b)制制定定質(zhì)質(zhì)量量方方針針,c)確確保保質(zhì)質(zhì)量量目目標(biāo)標(biāo)的的制制定定,d)進(jìn)進(jìn)行行管管理理評(píng)評(píng)審審,e)確確保保資資源源的的獲獲得得,225Managementresponsibility5管管理理層層職職責(zé)責(zé)5.1.1ProcessefficiencyTopmanagementshallreviewtheproductrealizationprocessesandthesupportprocessestoassuretheireffectivenessandefficiency.5.1.1過(guò)過(guò)程程有有效效性性最高高管管理理層層應(yīng)評(píng)審審產(chǎn)產(chǎn)品品的的實(shí)實(shí)現(xiàn)現(xiàn)過(guò)過(guò)程程和和支支持持過(guò)過(guò)程程以以確確保保它它們們的的有有效效性性和和效效率率。。235Managementresponsibility5管管理理層層職職責(zé)責(zé)5.2CustomerfocusTopmanagementshallensurethatcustomerrequirementsaredeterminedandfulfilledwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).5.2以以顧顧客客為為關(guān)關(guān)注注焦焦點(diǎn)點(diǎn)最高高管管理理者者應(yīng)以增增強(qiáng)強(qiáng)顧顧客客滿滿意意為為目目的的,確確保保顧顧客客的的要要求求得得到到確確定定并并予予以以滿滿足足(見見7.2.1和和8.2.1).245Managementresponsibility5管管理理層層職職責(zé)責(zé)5.3QualitypolicyTopmanagementshallensurethatthequalitypolicy.a)isappropriatetothepurposeoftheorganization,b)includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,c)providesaframeworkforestablishingandreviewingqualityobjectives,d)iscommunicatedandunderstoodwithintheorganization,ande)isreviewedforcontinuingsuitability.5.3質(zhì)質(zhì)量方方針最高管理理者應(yīng)確保質(zhì)量量方針:a)與與組織的的宗旨相相適應(yīng),b)包包括對(duì)滿滿足要求求和持續(xù)續(xù)改進(jìn)質(zhì)質(zhì)量管理理體系有有效性的的承諾,c)提提供制定定和評(píng)審審質(zhì)量目目標(biāo)的框框架,d)在在組織內(nèi)內(nèi)得到溝溝通和理理解e)在在持續(xù)適適宜性方方面得到到評(píng)審.255Managementresponsibility5管管理層層職責(zé)5.4Planning5.4.1QualityobjectivesTopmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct(see7.1)areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.5.4策策劃5.4.1質(zhì)質(zhì)量目標(biāo)標(biāo)最高管理理者應(yīng)確保在組組織的相相關(guān)職能能和層次次上建立立質(zhì)量目目標(biāo),質(zhì)質(zhì)量目標(biāo)標(biāo)包括滿滿足產(chǎn)品品要求所所需的內(nèi)內(nèi)容(見見7.1).質(zhì)質(zhì)量目標(biāo)標(biāo)應(yīng)是可測(cè)量的,并與質(zhì)量方方針保持一致致.265Managementresponsibility5管理理層職責(zé)Qualityobjectives-supplementalTopmanagementshalldefinequalityobjectivesandmeasurementsthatshallbeincludedinthebusinessplanandusedtodeploythequalitypolicy.NOTE:Qualityobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod.質(zhì)量目目標(biāo)-補(bǔ)補(bǔ)充最高管理層應(yīng)確定質(zhì)量目標(biāo)標(biāo)和度量指標(biāo)標(biāo)，應(yīng)包含于業(yè)務(wù)計(jì)計(jì)劃和用來(lái)展展開質(zhì)量方針針。注：質(zhì)量目標(biāo)標(biāo)中應(yīng)該注明明客戶的期望望，并在所定定期限內(nèi)可以以達(dá)到。275Managementresponsibility5管理理層職責(zé)5.4.2QualitymanagementsystemplanningTopmanagementshallensurethat:a)theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,andb)theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.5.4.2質(zhì)質(zhì)量管理體體系策劃最高管理者應(yīng)確保:a)對(duì)質(zhì)量量管理體系進(jìn)進(jìn)行策劃,以以滿足質(zhì)量目目標(biāo)以及4.1的要求,b)在對(duì)質(zhì)質(zhì)量管理體系系的變更進(jìn)行行策劃和實(shí)施施時(shí),保持質(zhì)質(zhì)量管理體系系的完整性.285Managementresponsibility5管理理層職責(zé)5.5Responsibility,authorityandcommunication5.5.1ResponsibilityandauthorityTopmanagementshallensurethattheresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization.5.5職責(zé)責(zé),權(quán)限與溝溝通5.5.1職職責(zé)和權(quán)限限最高管理者應(yīng)確保組織內(nèi)的的職責(zé),權(quán)限限得到規(guī)定和和溝通.295Managementresponsibility5管理理層職責(zé)ResponsibilityforQualityManagerswithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichdonotconformtorequirements.Personnelresponsibleforproductqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems.Productionoperationsacrossallshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityfor，ensuringproductquality.質(zhì)量職職責(zé)對(duì)糾正措施賦賦有職責(zé)和權(quán)權(quán)限的管理者者應(yīng)被及時(shí)通知不不符合要求的的產(chǎn)品或過(guò)程程。賦有產(chǎn)品質(zhì)量量職責(zé)的人員員應(yīng)有權(quán)限停止生生產(chǎn)以糾正質(zhì)質(zhì)量問(wèn)題。所有班次的生生產(chǎn)運(yùn)作應(yīng)有人員看管，，或委派相關(guān)關(guān)職責(zé)人員以以確保產(chǎn)品質(zhì)質(zhì)量。305Managementresponsibility5管理理層職責(zé)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應(yīng)指定一名管理理者,無(wú)論該該成員在其它它方面的職責(zé)責(zé)如何,應(yīng)具有以下方面面的職責(zé)和權(quán)權(quán)限:a)確保質(zhì)質(zhì)量管理體系系所需的過(guò)程程得到建立,實(shí)施和保持持,b)向最高高管理者報(bào)告告質(zhì)量管理體體系的業(yè)績(jī)和和任何改進(jìn)的的需求,c)確保在在整個(gè)組織內(nèi)內(nèi)提高滿足顧顧客要求的意意識(shí).注:管理者者代表的職責(zé)責(zé)可包括與質(zhì)質(zhì)量管理體系系有關(guān)事宜的的外部聯(lián)絡(luò).315Managementresponsibility5管理理層職責(zé)CustomerrepresentativeTopmanagementshalldesignatepersonnelwithresponsibilityandauthoritytoensurethecustomerrequirementsareaddressed.Thisincludesselectionofspecialcharacteristics,settingqualityobjectivesandrelatedtraining,correctiveandpreventiveactions,productdesignanddevelopment.客戶戶代表最高管理層應(yīng)指派人員擁有有職責(zé)和權(quán)限限以確保滿足足客戶要求。。包括選擇特特殊特性、建建立質(zhì)量目標(biāo)標(biāo)和相關(guān)的培培訓(xùn)、糾正和和預(yù)防措施、、產(chǎn)品設(shè)計(jì)和和開發(fā)。325Managementresponsibility5管理理層職責(zé)5.5.3InternalcommunicationTopmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplacesregardingtheeffectivenessofthequalitymanagementsystem.5.5.3內(nèi)內(nèi)部溝通最高管理者應(yīng)確保在組織內(nèi)內(nèi)建立適當(dāng)?shù)牡臏贤ㄟ^(guò)程,并確保對(duì)質(zhì)質(zhì)量管理體系系的有效性進(jìn)進(jìn)行溝通.335Managementresponsibility5管理理層職責(zé)5.6Managementreview5.6.1GeneralTopmanagementshallreviewtheorganization'squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitability,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives.Recordsfrommanagementreviewsshallbemaintained(see4.2.4)5.6管理理評(píng)審5.6.1總總則最高管理者應(yīng)按策劃的時(shí)間間間隔評(píng)審質(zhì)質(zhì)量管理體系系,以確保其其持續(xù)的適宜宜性,充分性性和有效性.評(píng)審應(yīng)包括評(píng)價(jià)質(zhì)量量管理體系改改進(jìn)的機(jī)會(huì)和和變更的需要要,包括質(zhì)量量方針和質(zhì)量量目標(biāo)..應(yīng)保持管理評(píng)評(píng)審的記錄錄(見4.2.4).345Managementresponsibility5管管理層職責(zé)責(zé)QualitymanagementsystemperformanceThesereviewsshallincludeallrequirementsofthequalitymanagementsystemanditsperformancetrendsasanessentialpartofthecontinualimprovementprocess.Partofthemanagementreviewshallbethemonitoringofqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality(see8.4.1and8.5.1)質(zhì)質(zhì)量管理體體系績(jī)效這些評(píng)審應(yīng)包括質(zhì)量管管理體系的的所有要求求，并且將將它的績(jī)效效趨勢(shì)作為為持續(xù)改進(jìn)進(jìn)過(guò)程的實(shí)實(shí)質(zhì)部分。。管理評(píng)審的的其中部分分應(yīng)是質(zhì)量目標(biāo)標(biāo)的監(jiān)控，，定期報(bào)告告和評(píng)價(jià)不不良質(zhì)量成成本。355Managementresponsibility5管管理層職責(zé)責(zé)Theseresultsshallberecordedtoprovide,asaminimum,evidenceoftheachievementof:-thequalityobjectivesspecifiedinthebusinessplan,and-customersatisfactionwithproductsupplied.這些結(jié)果應(yīng)被記錄，至至少可提供供作為證據(jù)據(jù)達(dá)到：-業(yè)務(wù)務(wù)計(jì)劃中規(guī)規(guī)定的質(zhì)量量目標(biāo)，和和-客戶戶對(duì)產(chǎn)品提提供的滿意意度。365Managementresponsibility5管管理層職責(zé)責(zé)5.6.2ReviewinputTheinputtomanagementreviewshallincludeinformationon:a)resultsofaudits,b)customerfeedback,c)processperformanceandproductconformity,d)statusofpreventiveandcorrectiveactions,e)follow-upactionsfrompreviousmanagementreviews,f)plannedchangesthatcouldaffectthequalitymanagementsystem,andg)recommendationsforimprovement.5.6.2評(píng)審輸輸入管理評(píng)審的的輸入應(yīng)包括以下方方面的信息息:a)審核核結(jié)果b)顧客客反饋c)過(guò)程程的業(yè)績(jī)和和產(chǎn)品的符符合性d)預(yù)防防和糾正措措施的狀況況e)以往往管理評(píng)審審的跟蹤措措施f)可能能影響質(zhì)量量管理體系系的變更g)改進(jìn)進(jìn)的建議375Managementresponsibility5管管理層職責(zé)責(zé)Reviewinput-SupplementalInputtomanagementreviewshallincludeananalysisofactualandpotentialfield-failuresandtheirimpactonquality,safety,ortheenvironment.評(píng)評(píng)審輸入-補(bǔ)充充管理評(píng)審的的輸入應(yīng)包括對(duì)實(shí)際際和潛在使使用失效的的分析以及及它們對(duì)質(zhì)質(zhì)量，安全全或環(huán)境的的影響。385Managementresponsibility5管管理層職責(zé)責(zé)5.6.3ReviewoutputTheoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto:a)improvementoftheeffectivenessofthequalitymanagementsystemanditsprocesses,b)improvementofproductrelatedtocustomerrequirements,andc)resourceneeds.5.6.3評(píng)審輸輸出管理評(píng)審的的輸出應(yīng)包括與以下下方面有關(guān)關(guān)的任何決決定和措施施:a)質(zhì)量量管理體系系及其過(guò)程程有效性的的改進(jìn)b)與顧顧客要求有有關(guān)的產(chǎn)品品的改進(jìn)c)資源源需求.396Resourcemanagement資源源管管理理406Resourcemanagement6資資源源管管理理6.1ProvisionofresourcesTheorganizationshalldetermineandprovidetheresourcesneeded:a)toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,andb)toenhancecustomersatisfactionbymeetingcustomerrequirements.6.1資資源源提提供供組織織應(yīng)確定定并并提提供供以以下下方方面面所所需需的的資資源源:a)實(shí)實(shí)施施,保保持持質(zhì)質(zhì)量量管管理理體體系系并并持持續(xù)續(xù)改改進(jìn)進(jìn)其其有有效效性性,b)通通過(guò)過(guò)滿滿足足顧顧客客要要求求,增增強(qiáng)強(qiáng)顧顧客客滿滿意意.416Resourcemanagement6資資源源管管理理6.2Humanresources6.2.1GeneralPersonnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience.6.2人人力力資資源源6.2.1總總則則基于于適適當(dāng)當(dāng)?shù)牡慕探逃?培培訓(xùn)訓(xùn),技技能能和和經(jīng)經(jīng)驗(yàn)驗(yàn),從從事事影影響響產(chǎn)產(chǎn)品品質(zhì)質(zhì)量量工工作作的的人人員員應(yīng)是能能夠夠勝勝任任的的.426Resourcemanagement6資資源源管管理理6.2.2Competence,awarenessandtrainingTheorganizationshall:a)determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality,b)providetrainingortakeotheractionstosatisfytheseneeds,c)evaluatetheeffectivenessoftheactionstaken,d)ensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,ande)maintainappropriaterecordsofeducation,training,skillsandexperience.6.2.2能能力力,意意識(shí)識(shí)和和培培訓(xùn)訓(xùn)組織織應(yīng):a)確確定定從從事事影影響響產(chǎn)產(chǎn)品品質(zhì)質(zhì)量量工工作作的的人人員員所所必必要要的的能能力力,b)提提供供培培訓(xùn)訓(xùn)或或采采取取其其它它措措施施以以滿滿足足這這些些需需求求,c)評(píng)評(píng)價(jià)價(jià)所所采采取取措措施施的的有有效效性性,d)確確保保員員工工認(rèn)認(rèn)識(shí)識(shí)到到所所從從事事活活動(dòng)動(dòng)的的相相關(guān)關(guān)性性和和重重要要性性,以以及及如如何何為為實(shí)實(shí)現(xiàn)現(xiàn)質(zhì)質(zhì)量量目目標(biāo)標(biāo)作作出出貢貢獻(xiàn)獻(xiàn),e)保保持持教教育育,培培訓(xùn)訓(xùn),技技能能和和經(jīng)經(jīng)驗(yàn)驗(yàn)的的適適當(dāng)當(dāng)記記錄錄.436Resourcemanagement6資資源源管管理理ProductdesignskillsTheorganizationshallensurethatpersonnelwithproductdesignresponsibilityarecompetenttoachievedesignrequirementsandareskilledinapplicabletoolsandtechniques.Applicabletoolsandtechniquesshallbeidentifiedbytheorganization.產(chǎn)產(chǎn)品設(shè)計(jì)技術(shù)術(shù)組織應(yīng)確保負(fù)責(zé)產(chǎn)品品設(shè)計(jì)的人員員有能力完成成設(shè)計(jì)要求并并熟練使用適適用的工具和和技巧。適用的工具和和技巧應(yīng)被組織識(shí)別。446Resourcemanagemnet6資資源管理TrainingTheorganizationshallestablishandmaintaindocumentedproceduresforidentifyingtrainingneedsandachievingcompetenceofallpersonnelperformingactivitiesaffectingproductquality.Personnelperformingspecificassignedtasksshallbequalified，asrequiredwithparticularattentiontothesatisfactionofcustomerrequirements.培培訓(xùn)組織應(yīng)建立和保持文文件化程序以以識(shí)別培訓(xùn)需需求和影響產(chǎn)產(chǎn)品質(zhì)量的所所有員工具備備能力。執(zhí)行行特殊任務(wù)的的員工應(yīng)具備資格，特特殊關(guān)注按照照滿足客戶要要求。456Resourcemanagemnet6資資源管理TrainingNOTE1Thisappliestoallemployeesaffectingqualityatalllevelsoftheorganization.NOTE2Anexampleofthecustomerspecificrequirementsistheapplicationofdigitizedmathematicallybaseddata.培訓(xùn)訓(xùn)注1適用于于組織各個(gè)階階層的對(duì)質(zhì)量量有影響的所所有員工。注2客戶特特殊要求的一一個(gè)例子是數(shù)數(shù)字?jǐn)?shù)據(jù)的應(yīng)應(yīng)用。466Resourcemanagemnet6資資源管理在在職培訓(xùn)組織應(yīng)向員工，包括括合同或中介介人員提供關(guān)關(guān)于影響產(chǎn)品品質(zhì)量的新的的或修改過(guò)的的作業(yè)的在職職培訓(xùn)。對(duì)質(zhì)質(zhì)量有影響的的員工，應(yīng)被通知關(guān)于不不符合質(zhì)量要要求對(duì)客戶的的后果。TrainingonthejobTheorganizationshallprovideonthejobtrainingforpersonnelinanynewormodifiedjobaffectingproductqualityincludingcontractoragencypersonnel.Personnelwhoseworkcanaffectqualityshallbeinformedabouttheconsequencestothecustomerofnon-conformitytoqualityrequirements.476Resourcemanagemnet6資資源管理員工的的積極性和推推動(dòng)組織應(yīng)具備一過(guò)程以以激勵(lì)員工達(dá)達(dá)成質(zhì)量目標(biāo)標(biāo)，做到持續(xù)續(xù)改進(jìn)，并創(chuàng)創(chuàng)造一個(gè)促進(jìn)進(jìn)革新的環(huán)境境。這個(gè)過(guò)程程應(yīng)包括整個(gè)組織織對(duì)質(zhì)量和技技術(shù)意識(shí)的提提升。EmployeemotivationandempowermentTheorganizationshallhaveaprocesstomotivateemployeestoachievequalityobjectives,tomakecontinualimprovements,andtocreateanenvironmenttopromoteinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.486Resourcemanagemnet6資資源管理員工的的積極性和推推動(dòng)組織應(yīng)具備一測(cè)量過(guò)過(guò)程以保證其其人員了解他他們活動(dòng)的恰恰當(dāng)性和重要要性及他們?nèi)缛绾斡兄谶_(dá)達(dá)到質(zhì)量目標(biāo)標(biāo)(見6.2.2d)。EmployeemotivationandempowermentTheorganizationshallhaveaprocesstomeasuretheextenttowhichitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives(see6.2.2d).496Resourcemanagement6資資源管理6.3InfrastructureTheorganizationshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicablea)buildings,workspaceandassociatedutilities,b)processequipment,(bothhardwareandsoftware),andc)supportingservices(suchastransportorcommunication).6.3基基礎(chǔ)設(shè)設(shè)施組織應(yīng)確定,提供供并維維護(hù)為為達(dá)到到產(chǎn)品品符合合要求求所需需的基基礎(chǔ)設(shè)設(shè)施.適適用時(shí)時(shí),基基礎(chǔ)設(shè)設(shè)施包包括:a)建建筑筑物,工作作場(chǎng)所所和相相關(guān)的的設(shè)施施b)過(guò)過(guò)程程設(shè)備備(硬硬件和和軟件件)c)支支持持性服服務(wù)(如運(yùn)運(yùn)輸或或通訊訊).506Resourcemanagemnet6資資源管管理6.3.1工工廠，，設(shè)施施和設(shè)設(shè)備策策劃組織應(yīng)采用多多方論論證方方式(見)以以開開發(fā)工工廠，，設(shè)施施和設(shè)設(shè)備的的計(jì)劃劃。工工廠的的布局局應(yīng)優(yōu)化材材料的的運(yùn)輸輸，搬搬運(yùn)及及增值值使用用空間間，并并應(yīng)方便材材料的的同步步流動(dòng)動(dòng)。應(yīng)開發(fā)和和實(shí)施施方法法來(lái)評(píng)評(píng)估和和監(jiān)控控現(xiàn)有有運(yùn)作作的有有效性性。6.3.1Plant,facilityandequipmentplanningTheorganizationshalluseamultidisciplinaryapproach(see)fordevelopingplant,facilityandequipmentplans.Plantlayoutsshalloptimizematerialtravel,handlingandvalue-addeduseoffloorspace,andshallfacilitatesynchronousmaterialflow.Methodsshallbedevelopedandimplementedtoevaluateandmonitortheeffectivenessofexistingoperations.516Resourcemanagemnet6資資源管管理6.3.1工工廠，，設(shè)施施和設(shè)設(shè)備策策劃注這這些要要求應(yīng)應(yīng)該關(guān)關(guān)注于于精益益生產(chǎn)產(chǎn)原則則及與與質(zhì)量量管理理體系系有效效性的的連系系。6.3.1Plant,facilityandequipmentplanningNOTETheserequirementsshouldfocusonleanmanufacturingprinciplesandthelinktotheeffectivenessofthequalitymanagementsystem.526Resourcemanagemnet6資資源管管理6.3.2ContingencyplansTheorganizationshallpreparecontingencyplanstosatisfythecustomerrequirementsintheeventofanemergencysuchasutilityinterruptions,labourshortages,keyequipmentfailure,andfieldreturns.6.3.2應(yīng)應(yīng)急急計(jì)劃劃組織應(yīng)準(zhǔn)備應(yīng)應(yīng)急計(jì)計(jì)劃以以在緊緊急情情況下下，諸諸如供供應(yīng)中中斷，，勞動(dòng)動(dòng)力短短缺，，關(guān)鍵鍵設(shè)備備故障障和市市場(chǎng)退退回時(shí)時(shí)，滿滿足客客戶要要求。。536Resourcemanagement6資資源源管理理6.4WorkenvironmentTheorganizationshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements.6.4工工作環(huán)環(huán)境組織應(yīng)確定并并管理理為達(dá)達(dá)到產(chǎn)產(chǎn)品符符合要要求所所需的的工作作環(huán)境境.546Resourcemanagement6資資源管管理6.4.1PersonnelsafetytoachieveproductqualityProductsafetyandmeanstominimizepotentialriskstoemployeesshallbeaddressedbytheorganization,especiallyindesignanddevelopmentprocessandinthemanufacturingprocessactivities.6.4.1人人員安安全以以達(dá)到到產(chǎn)品品質(zhì)量量產(chǎn)品安安全性性和降降低對(duì)對(duì)員工工的潛潛在風(fēng)風(fēng)險(xiǎn)的的方法法應(yīng)由組織織提出出，尤尤其是是設(shè)計(jì)計(jì)和開開發(fā)過(guò)過(guò)程及及生產(chǎn)產(chǎn)過(guò)程程活動(dòng)動(dòng)。556Resourcemanagemnet6資資源管管理6.4.2CleanlinessofpremisesTheorganizationshallmaintainitspremisesinastateoforder，cleanlinessandrepairconsistentwiththeproductandmanufacturingprocessneeds.6.4.2廠區(qū)的的清潔組織應(yīng)保持廠區(qū)與與產(chǎn)品一致致的有序、、清潔，并并按產(chǎn)品和和制造過(guò)程程需求進(jìn)行行適當(dāng)?shù)木S維護(hù)。567ProductRealization產(chǎn)品實(shí)現(xiàn)577productrealization7產(chǎn)產(chǎn)品實(shí)實(shí)現(xiàn)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產(chǎn)產(chǎn)品實(shí)現(xiàn)的的策劃組織應(yīng)策劃和開發(fā)發(fā)產(chǎn)品實(shí)現(xiàn)現(xiàn)所需的過(guò)過(guò)程.產(chǎn)產(chǎn)品實(shí)現(xiàn)的的策劃應(yīng)與質(zhì)量管理理體系其它它過(guò)程的要要求相一致致(見4.1).a)產(chǎn)品品的質(zhì)量目目標(biāo)和要求求b)針對(duì)對(duì)產(chǎn)品確定定過(guò)程,文文件和資源源的需求c)產(chǎn)品品所要求的的驗(yàn)證,確確認(rèn),監(jiān)視視,檢驗(yàn)和和試驗(yàn)活動(dòng)動(dòng),以及產(chǎn)產(chǎn)品接收準(zhǔn)準(zhǔn)則d)為實(shí)實(shí)現(xiàn)過(guò)程及及其產(chǎn)品滿滿足要求提提供證據(jù)所所需的記錄錄(見4.2.4)策劃的輸出出形式應(yīng)適用于組織織的運(yùn)作方方式.587productrealization7產(chǎn)產(chǎn)品實(shí)實(shí)現(xiàn)7.1PlanningofproductrealizationNOTE1:Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingtheproductrealizationprocesses)andtheresourcestobeappliedtoaspecificproduct,projectorcontract,canbereferredtoasaqualityplan.NOTE2:Theorganizationmayalsoapplytherequirementsgivenin7.3tothedevelopmentofproductrealizati