ISO-TS16949：2009質(zhì)量管理體系中英文對照版

ISO/TS16949：2009技術(shù)規(guī)范TECHNICALSPECIFICATION質(zhì)量管理體系-汽車生產(chǎn)件及相關(guān)服務(wù)件組織應(yīng)用ISO9001：2008的特殊要求Qualitymanagementsystems—ParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproductionandrelevantservicepartorganizations目錄Contents前言Foreword………………7有關(guān)認(rèn)證的說明Remarksforcertification…………………9引言Introduction……………100.1總則General……………100.2過程方法Processapproach………………110.3與ISO9004的關(guān)系RelationshipwithISO9004………130.4與其他管理體系的相容性Compatibilitywithothermanagementsystems……………140.5本技術(shù)規(guī)范的目的GoalofthisTechnicalSpecification………………151范圍Scope…………………161.1總則General……………161.2應(yīng)用Application…………172引用標(biāo)準(zhǔn)Normativereference……………173術(shù)語和定義Termsanddefinitions…………183.1汽車行業(yè)術(shù)語和定義Termsanddefinitionsfortheautomotiveindustry………………184質(zhì)量管理體系Qualitymanagementsystem………………204.1總要求Generalrequirements…………204.1。1總要求—補(bǔ)充Generalrequirements-Supplemental…………………214.2文件要求Documentationrequirements…………………214.2.1總則General…………214。2.2質(zhì)量手冊Qualitymanual……………224。2.3文件控制Controlofdocuments………224。2。3。1工程規(guī)范Engineeringspecifications………………234.2.4記錄控制Controlofrecords…………234。2.4。1記錄保存Recordsretention………245管理職責(zé)Managementresponsibility……………………245.1管理承諾Managementcommitment……………………245.1。1過程效率Processefficiency…………245。2以顧客為關(guān)注焦點(diǎn)Customerfocus……………………245。3質(zhì)量方針Qualitypolicy………………255.4策劃Planning……………255。4.1質(zhì)量目標(biāo)Qualityobjectives…………255。4.1.1質(zhì)量目標(biāo)—補(bǔ)充Qualityobjectives—Supplemental………………255。4。2質(zhì)量管理體系的策劃Qualitymanagementsystemplanning…………265.5職責(zé)、權(quán)限與溝通Responsibility,authorityandcommunication………265。5.1職責(zé)和權(quán)限Responsibilityandauthority……………2質(zhì)量職責(zé)Responsibilityforquality…………………265。5。2管理者代表Managementrepresentative………………2顧客代表Customerrepresentative…………………275。5.3內(nèi)部溝通Internalcommunication……………………275.6管理評審Managementreview…………275。6.1總則General……………275。6。1.1質(zhì)量管理體系績效Qualitymanagementsystemperformance……285。6。2評審輸入Reviewinput………………285。6.2.1評審輸入—補(bǔ)充Reviewinput—Supplemental……285.6。3評審輸出Reviewoutput………………296資源管理Resourcemanagement…………296。1資源提供Provisionofresources…………296.2人力資源Humanresources………………296.2。1總則General……………306。2.2能力、培訓(xùn)和意識Competence,trainingandawareness……………306。2.2.1產(chǎn)品設(shè)計(jì)技能Productdesignskills…………………306。2。2。2培訓(xùn)Training…………316。2.2.3崗位培訓(xùn)……………316。2。2。4員工的激勵Employeemotivationandempowerment………………316.3基礎(chǔ)設(shè)施Infrastructure…………………316。3.1工廠、設(shè)施和設(shè)備策劃Plant,facilityandequipmentplanning………326.3。2應(yīng)急計(jì)劃Contingencyplans…………326。4工作環(huán)境Workenvironment……………326。4.1為達(dá)成產(chǎn)品要求符合性的人員安全Personnelsafetytoachieveconformityproductrequirements…………………326。4。2生產(chǎn)現(xiàn)場的清潔Cleanlinessofpremises……………327產(chǎn)品實(shí)現(xiàn)Productrealization………………337。1產(chǎn)品實(shí)現(xiàn)的策劃Planningofproductrealization………337.1.1產(chǎn)品實(shí)現(xiàn)的策劃—補(bǔ)充Planningofproductrealization-Supplemental……………347.1。2接收準(zhǔn)則Acceptancecriteria…………347.1。3保密性Confidentiality…………………347.1。4更改控制Changecontrol………………347。2與顧客有關(guān)的過程Customer—relatedprocesses…………347.2。1與產(chǎn)品有關(guān)的要求的確Determinationofrequirementsrelatedtotheproduct………357.2。1.1顧客指定的特殊特性Customer-designatedspecialcharacteristics…357。2.2與產(chǎn)品有關(guān)的要求的評審Reviewofrequirementsrelatedtotheproduct…………357。2.2.1與產(chǎn)品有關(guān)的要求的評審—補(bǔ)充Reviewofrequirementsrelatedtotheproduc-Supplemental…………………367。2.2.2組織制造可行性O(shè)rganizationmanufacturingfeasibility…………367.2.3顧客溝通Customercommunication…………………367.2。3.1顧客溝通—補(bǔ)充Customercommunication—Supplemental………377。3設(shè)計(jì)和開發(fā)Designanddevelopment……………………377。3.1設(shè)計(jì)和開發(fā)策劃Designanddevelopmentplanning…………………377。3。1.1多方論證方法Multidisciplinaryapproach…………377。3.2設(shè)計(jì)和開發(fā)輸入Designanddevelopmentinputs……387.3。2.1產(chǎn)品設(shè)計(jì)輸入Productdesigninput…………………387。3。2。2制造過程設(shè)計(jì)輸入Manufacturingprocessdesigninput……………397.3.2。3特殊特性Specialcharacteristics……………………397。3.3設(shè)計(jì)和開發(fā)輸出Designanddevelopmentoutputs……397。3。3。1產(chǎn)品設(shè)計(jì)輸出—補(bǔ)充Productdesignoutputs—Supplemental……407.3。3.2制造過程設(shè)計(jì)輸出Manufacturingprocessdesignoutput…………407。3。4設(shè)計(jì)和開發(fā)評審Designanddevelopmentreview……417。3.4。1監(jiān)視Monitoring……………………417。3.5設(shè)計(jì)和開發(fā)驗(yàn)證Designanddevelopmentverification………………427。3。6設(shè)計(jì)和開發(fā)確認(rèn)Designanddevelopmentvalidation………………4設(shè)計(jì)和開發(fā)確認(rèn)—補(bǔ)充Designanddevelopmentvalidation-Supplemental……427.3。6.2樣件計(jì)劃Prototypeprogramme……………………427。3。6。3產(chǎn)品批準(zhǔn)過程Productapprovalprocess…………437.3。7設(shè)計(jì)和開發(fā)更改的控制Controlofdesignanddevelopmentchanges………………437。4采購Purchasing………………………437.4.1采購過程Purchasingprocess…………447。4。1.1法規(guī)符合性Regulatoryconformity…………………447。4.1。2供方質(zhì)量管理體系開發(fā)Supplierqualitymanagementsystemdevelopment………4顧客批準(zhǔn)的供方Customer-approvedsources………447.4.2采購信息Purchasinginformation……………………457。4.3采購產(chǎn)品的驗(yàn)證Verificationofpurchasedproduct…………………4進(jìn)貨產(chǎn)品對要求的符合性Incomingproductconformitytorequirements…………457。4。3。2對供方監(jiān)視Suppliermonitoring……………………467.5生產(chǎn)和服務(wù)提供Productionandserviceprovision……467.5.1生產(chǎn)和服務(wù)提供的控制Controlofproductionandserviceprovision………………467。5.1.1控制計(jì)劃Controlplan………………477。5.1.2作業(yè)指導(dǎo)書Workinstructions………477.5。1。3作業(yè)準(zhǔn)備驗(yàn)證Verificationofjobsetups……………477。5。1.4預(yù)防性和預(yù)見性維護(hù)Preventiveandpredictivemaintenance……4生產(chǎn)工裝的管理Managementofproductiontooling………………487.5。1。6生產(chǎn)計(jì)劃Productionscheduling……………………497。5。1.7服務(wù)信息反饋Feedbackofinformationfromservice………………497。5.1.8與顧客的服務(wù)協(xié)議Serviceagreementwithcustomer………………497。5.2生產(chǎn)和服務(wù)提供過程的確認(rèn)Validationofprocessesforproductionandserviceprovision……………………497。5。2.1生產(chǎn)和服務(wù)提供過程的確認(rèn)—補(bǔ)充Validationofprocessesforproductionandserviceprovision—Supplemental……………507.5。3標(biāo)識和可追溯性Identificationandtraceability………507。5.3.1標(biāo)識和可追溯性—補(bǔ)充Identificationandtraceability–Supplemental……………507.5.4顧客財(cái)產(chǎn)Customerproperty…………5顧客所有的工裝Customer-ownedproductiontooling……………517。5.5。產(chǎn)品防護(hù)Preservationofproduct……………………517.5.5。1貯存和庫存Storageandinventory…………………517.6監(jiān)視和測量設(shè)備的控制Controlofmonitoringandmeasuringequipment……………527.6.1測量系統(tǒng)分析Measurementsystemanalysis…………537。6。2校準(zhǔn)/驗(yàn)證記錄Calibration/verificationrecords………537.6.3實(shí)驗(yàn)室要求Laboratoryrequirements…………………537。6.3。1內(nèi)部實(shí)驗(yàn)室Internallaboratory………537.6。3。2外部實(shí)驗(yàn)室Externallaboratory……………………548測量、分析和改進(jìn)Measurement,analysisandimprovement……………548.1總則General……………558.1.1統(tǒng)計(jì)工具的確定Identificationofstatisticaltools……558。1.2基礎(chǔ)統(tǒng)計(jì)概念知識Knowledgeofbasicstatisticalconcepts………558。2監(jiān)視和測量Monitoringandmeasurement……………558.2.1顧客滿意Customersatisfaction………558。2.1.1顧客滿意—補(bǔ)充Customersatisfaction—Supplemental……………568.2.2內(nèi)部審核Internalaudit………………568.2。2。1質(zhì)量管理體系審核Qualitymanagementsystemaudit……………578。2。2。2制造過程審核Manufacturingprocessaudit…………578。2。2.3產(chǎn)品審核Productaudit………………578.2。2。4內(nèi)部審核計(jì)劃Internalauditplans…………………578.2.2。5內(nèi)審員資格Internalauditorqualification……………578.2.3過程的監(jiān)視和測量Monitoringandmeasurementofprocesses………588.2。3。1制造過程的監(jiān)視和測量Monitoringandmeasurementofmanufacturingprocesses588.2。4產(chǎn)品的監(jiān)視和測量Monitoringandmeasurementofproduct…………598.2。4。1全尺寸檢驗(yàn)和功能試驗(yàn)Layoutinspectionandfunctionaltesting…598.2.4。2外觀項(xiàng)目Appearanceitems…………608.3不合格品控制Controlofnonconformingproduct………608。3.1不合格品控制—補(bǔ)充Controlofnonconformingproduct—Supplemental…………618。3。2返工產(chǎn)品的控制Controlofreworkedproduct………618.3。3顧客通知Customerinformation………618.3。4顧客特許Customerwaiver……………618.4數(shù)據(jù)分析Analysisofdata………………618.4。1數(shù)據(jù)分析和使用Analysisanduseofdata……………628.5改進(jìn)Improvement………………………628。5.1持續(xù)改進(jìn)Continualimprovement……………………628。5.1。1組織的持續(xù)改進(jìn)Continualimprovementoftheorganization………628。5.1.2制造過程的改進(jìn)Manufacturingprocessimprovement……………628。5。2糾正措施Correctiveaction……………638。5。2。1解決問題的方法Problemsolving…………………638。5。2。2防錯Error—proofing…………………638。5。2.3糾正措施影響Correctiveactionimpact……………638。5。2.4拒收產(chǎn)品的試驗(yàn)/分析Rejectedproducttest/analysis………………638。5。3預(yù)防措施Preventiveaction……………64附錄A控制計(jì)劃AnnexA（normative)Controlplan………65參考文獻(xiàn)Bibliography………………………67前言Foreword國際標(biāo)準(zhǔn)化組織(ISO)是由各國標(biāo)準(zhǔn)化機(jī)構(gòu)（ISO成員機(jī)構(gòu))組成的世界性聯(lián)合會。國際標(biāo)準(zhǔn)的擬定由ISO技術(shù)委員會負(fù)責(zé)。各成員機(jī)構(gòu)若對某技術(shù)委員會所選定的主題感興趣,均有權(quán)參加該委員會的工作。與ISO保持聯(lián)系的各國組織(官方的或非官方的）也可參加該項(xiàng)工作。ISO與國際電器委員會（IEC）在電工技術(shù)標(biāo)準(zhǔn)化方面保持密切合作的關(guān)系。ISO(theInternationalOrganizationforStandardization）isaworldwidefederationofnationalstandardsbodies（ISOmemberbodies)。TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees。Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations，governmentalandnon—governmental,inliaisonwithISO,alsotakepartinthework。ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission（IEC)onallmattersofelectrotechnicalstandardization。本國際標(biāo)準(zhǔn)是依照ISO/IEC導(dǎo)則第2部分中的規(guī)則制定的。InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives，Part2.技術(shù)委員會的主要任務(wù)是制定國際標(biāo)準(zhǔn)。本國際技術(shù)標(biāo)準(zhǔn)草案已由技術(shù)委員會通過,并傳閱各成員機(jī)構(gòu)一共投票表決.國際標(biāo)準(zhǔn)的公布需要至少75％的參加投票的成員團(tuán)體批準(zhǔn)。Themaintaskoftechnicalcommitteesistoprepareinternationalstandards。DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.Publicationasaninternationalstandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.在其它情況下,特別是在市場急需某個文件時，技術(shù)委員會可以決定出版其他形式的規(guī)范文件：Inothercircumstances,particularlywhenthereisanurgentmarketrequirementforsuchdocuments,atechnicalcommitteemaydecidetopublishothertypesofnormativedocument：—ISO公布的可獲得規(guī)范（ISO/PAS）代表一項(xiàng)在一個ISO工作小組內(nèi)的技術(shù)專家達(dá)成的協(xié)議,在相應(yīng)委員會的成員的投票中有50%投票贊成后就可以出版發(fā)行；—anISOPubliclyAvailableSpecification(ISO/PAS)representsanagreementbetweentechnicalexpertsinanISOworkinggroupandisacceptedforpublicationifitisapprovedby50％ofthemembersoftheparentcommitteecastingavote；-ISO技術(shù)規(guī)范(ISO/TS），是技術(shù)委員會成員之間達(dá)成的協(xié)議，在委員會成員所投票中有2/3投票贊成后就可以出版發(fā)行.—anISOTechnicalSpecification（ISO/TS）representsanagreementbetweenthemembersofatechnicalcommitteeandisacceptedforpublicationifitisapprovedby2/3ofthemembersofthecommitteecastingavote。ISO/TS16949是由國際汽車工業(yè)特別行動小組（IATF），在ISO/TC176質(zhì)量管理和質(zhì)量保證技術(shù)委員會支持下制定的。ISO/TS16949waspreparedbytheInternationalAutomotiveTaskForce(IATF)withsupportfromISO/TC176,Qualitymanagementandqualityassurance。通過根據(jù)ISO9001：2008所作的技術(shù)修訂,第三版的ISO/TS16949取消并替代了第二版(ISO/TS16949:2002)ThisthirdeditionofISO/TS16949cancelsandreplacesthesecondedition(ISO/TS16949:2002）,whichhasbeentechnicallyamendedaccordingtoISO9001:2008。方框內(nèi)的文本是ISO9001：2008的原文內(nèi)容，方框外是行業(yè)特殊補(bǔ)充的要求。BoxedtextisoriginalISO9001:2008text。Thesector-specificsupplementalrequirementsareoutsidetheboxes。在本技術(shù)規(guī)范中，“應(yīng)”（shall）表示要求,“應(yīng)當(dāng)”（should）表示建議.標(biāo)示有“注”（NOTE）的段落是對理解或澄清相關(guān)要求的指南.InthisTechnicalSpecification,theword“shall”indicatesarequirement。Theword“should”indicatesarecommendation.Paragraphsmarked“NOTE"areforguidanceinunderstandingorclarifyingtheassociatedrequirement。所有用“例如"引出的建議都只具有指導(dǎo)性作用。Wheretheterm“suchas”isused,anysuggestionsgivenareforguidanceonly。附錄A是本技術(shù)規(guī)范的引用文件,構(gòu)成技術(shù)規(guī)范的一部分。AnnexAformsanormativepartofthisTechnicalSpecification。有關(guān)認(rèn)證的說明Remarksforcertification按照IATF的認(rèn)證方案（見《IATF認(rèn)可規(guī)則》）所獲取的本技術(shù)規(guī)范的認(rèn)證，包括任何的顧客特殊要求(如果有）,將獲得IATF的顧客成員的認(rèn)可.詳細(xì)情況可以從以下的國際汽車推動小組的當(dāng)?shù)乇O(jiān)督辦公室處獲得：意大利汽車工業(yè)協(xié)會（ANFIA）www.anfia。it美國國際汽車監(jiān)督署（IAOB)IATF—France英國汽車制造與貿(mào)易商謝(SMMT）www.smmt。co。uk德國汽車工業(yè)協(xié)會-質(zhì)量管理中心(VDA-QMC)www。vda—qmc。deThecertificationtothisTechnicalSpecification,includingcustomer-specificrequirementsifany，isrecognizedbythecustomermembersofIATFwhenachievedaccordingtotheIATFcertificationscheme(seethe“RulesforachievingIATFrecognition”）.DetailscanbeobtainedattheaddressesofthelocaloversightofficesofIATFcitedbelow：AssociazioneNazionaleFraIndustrieAutomobilistiche（ANFIA）Website：www.anfia。itInternationalAutomotiveOversightBureau（IAOB)Website:IATF—FranceWebsite：www.iatf—SocietyofMotorManufacturersandTradersLtd。(SMMTLtd。）Website:www。smmt.co.ukVerbandderAutomobilindustrieQualit？tsmanagementCenter(VDA—QMC）Website：www.vda-qmc。de引言Introduction0.1總則GeneralISO9001:2008質(zhì)量管理體系要求ISO9001：2008Qualitymanagementsystems—Requirements引言Introduction0。1總則General采納質(zhì)量管理體系是組織的一項(xiàng)戰(zhàn)略性決策.一個組織的質(zhì)量管理體系的設(shè)計(jì)和實(shí)施受下列因素的影響：Theadoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganization。Thedesignandimplementationofanorganization'squalitymanagementsystemisinfluencedby：a）組織的環(huán)境、該環(huán)境的變化或與該環(huán)境有關(guān)的風(fēng)險(xiǎn)；b）組織不斷變化的需求；c）組織的具體目標(biāo)；d）組織所提供的產(chǎn)品；e）組織所采用的過程；f)組織的規(guī)模和組織結(jié)構(gòu)。a)Itsorganizationalenvironment，changesinthatenvironment，andtherisksassociatedwiththatenvironment;b)Itsvaryingneeds；c）Itsparticularobjectives；d）Theproductsitprovides;e）Theprocessesitemploys;f）Itssizeandorganizationalstructure.統(tǒng)一質(zhì)量管理體系的結(jié)構(gòu)或文件不是本標(biāo)準(zhǔn)的目的.ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.本標(biāo)準(zhǔn)規(guī)定的質(zhì)量管理體系要求是對產(chǎn)品要求的補(bǔ)充.“注"是理解和說明有關(guān)要求的指南。ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts。Informationmarked?！癗OTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.本標(biāo)準(zhǔn)能用于內(nèi)部和外部(包括認(rèn)證機(jī)構(gòu))評價(jià)組織滿足顧客、適用于產(chǎn)品的法律法規(guī)要求和組織自身要求的能力。ThisInternationalStandardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganization’sabilitytomeetcustomer,regulatoryandtheorganization'sownrequirements.本標(biāo)準(zhǔn)的制定已經(jīng)考慮了GB/T19000和GB/T19004中所闡明的質(zhì)量管理原則.ThequalitymanagementprinciplesstatedinISO9000andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.0.2過程方法ProcessapproachISO9001：2008質(zhì)量管理體制體系-要求ISO9001:2008Qualitymanagementsystems—Requirements本標(biāo)準(zhǔn)鼓勵在建立、實(shí)施質(zhì)量管理體系以及在改進(jìn)其有效性時采用過程方法，通過滿足顧客要求，增強(qiáng)顧客滿意度。ThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem，toenhancecustomersatisfactionbymeetingcustomerrequirements.為了使組織有效運(yùn)行，應(yīng)確定和管理許多相互聯(lián)系的活動.通過使用資源和管理，將輸入轉(zhuǎn)換為輸出的一項(xiàng)或一組活動，可視為一個過程，通常,一個過程的輸出直接形成下一個過程的輸入。Foranorganizationtofunctioneffectively，ithastodetermineandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess。Oftentheoutputfromoneprocessdirectlyformstheinputtothenext。為了產(chǎn)生期望的結(jié)果，由過程組成的系統(tǒng)在組織內(nèi)的應(yīng)用,連同這些過程的識別和相互作用，以及對這些過程的管理，可稱之為“過程方法”。Theapplicationofasystemofprocesseswithinanorganization，togetherwiththeidentificationandinteractionsoftheseprocesses，andtheirmanagementtoproducethedesiredoutcome,canbereferredtoasthe“processapproach”。過程方法的一個優(yōu)點(diǎn)是對過程系統(tǒng)中單個過程之間的聯(lián)系以及過程的組合和相互作用進(jìn)行連續(xù)的控制。Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteraction.在質(zhì)量管理體系應(yīng)用過程方法時，強(qiáng)調(diào)以下方面的重要性：a）理解和滿足要求；b）需要從增值的角度考慮過程；c)獲得過程績效和有效性的結(jié)果;d）在客觀測量的基礎(chǔ)上，持續(xù)改進(jìn)過程。Whenusedwithinaqualitymanagementsystem,suchanapproachemphasizestheimportanceof：a)Understandingandfulfillingrequirements；b）Theneedtoconsiderprocessesintermsofaddedvalue；c)Obtainingresultsofprocessperformanceandeffectiveness；andd）Continualimprovementofprocessesbasedonobjectivemeasurement。圖1所反映的以過程為基礎(chǔ)的質(zhì)量管理體系模式展示了第4章至第8章中所提出的過程聯(lián)系。該圖反映了在規(guī)定輸入要求時，顧客起著重要的作用.對顧客滿意的監(jiān)視,要求組織對顧客關(guān)于組織是否已滿足其要求的感受信息進(jìn)行評價(jià)。該模式雖覆蓋了本標(biāo)準(zhǔn)的所有要求，但卻未詳細(xì)地反映各過程。Themodelofaprocess-basedqualitymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinclauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputs.Monitoringofcustomersatisfactionrequirestheevaluationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard，butdoesnotshowprocessesatadetailedlevel.注:此外，稱之為“PDCA"的方法可適用于所有過程。PDCA模式可簡述如下：P－策劃：根據(jù)顧客的要求和組織的方針，為提供結(jié)果建立必要的目標(biāo)和過程；D－實(shí)施：實(shí)施過程;C－檢查:根據(jù)方針、目標(biāo)和產(chǎn)品要求，對過程和產(chǎn)品進(jìn)行監(jiān)視和測量,并報(bào)告結(jié)果;A－處置：采取措施，以持續(xù)改進(jìn)過程業(yè)績。NOTE:Inaddition,themethodologyknownas"Plan—Do—Check-Act”（PDCA)canbeappliedtoallprocesses。PDCAcanbebrieflydescribedasfollows:Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganization’spolicies；Do:implementtheprocesses；Check:monitorandmeasureprocessesandproductagainstpolicies，objectivesandrequirementsfortheproductandreporttheresults;Act:takeactionstocontinuallyimproveprocessperformance。0。3與ISO9004的關(guān)系RelationshipwithISO9004ISO9001:2008質(zhì)量管理體制體系—要求ISO9001:2008Qualitymanagementsystems-Requirements0。3與ISO9004的關(guān)系RelationshipwithISO9004ISO9001和ISO9004都是質(zhì)量管理體系標(biāo)準(zhǔn)，這兩項(xiàng)標(biāo)準(zhǔn)相互補(bǔ)充，但也可單獨(dú)使用.ISO9001andISO9004arequalitymanagementsystemstandardswhichhavebeendesignedtocomplementeachother，butcanalsobeusedindependently。ISO9001規(guī)定了質(zhì)量管理體系要求，可供組織內(nèi)部使用，也可用于認(rèn)證或合同目的.ISO9001所關(guān)注的是質(zhì)量管理體系在滿足顧客要求方面的有效性。ISO9001specifiesrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposes。Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements。在本標(biāo)準(zhǔn)發(fā)布時，ISO9004處于修訂中。修訂后的ISO9004將為組織在復(fù)雜、要求更高和不斷變化的環(huán)境中獲得持續(xù)成功提供管理指南。與ISO9001相比，ISO9004關(guān)注質(zhì)量管理的更寬范圍;通過系統(tǒng)和持續(xù)改進(jìn)組織的績效，滿足所有相關(guān)方的需求和期望。然而ISO9004不擬于用于認(rèn)證、法律法規(guī)和合同的目的.AtthetimeofpublicationofthisInternationalStandard,ISO9004isunderrevision.TherevisededitionofISO9004willprovideguidancetomanagementforachievingsustainedsuccessforanyorganizationinacomplex,demanding,andeverchanging，environment。ISO9004providesawiderfocusonqualitymanagementthanISO9001；itaddressestheneedsandexpectationsofallinterestedpartiesandtheirsatisfaction，bythesystematicandcontinualimprovementoftheorganization’sperformance。However,itisnotintendedforcertification，regulatoryorcontractualuse。注：應(yīng)當(dāng)由最高管理者在組織內(nèi)宣傳和貫徹ISO9000：2005和ISO9004中涉及的八項(xiàng)質(zhì)量管理原則的知識及其應(yīng)用。Note:TheknowledgeanduseoftheeightqualitymanagementprinciplesreferredtointheISO9000:2005andISO9004shouldbedemonstratedandcascadedthroughtheorganizationbytopmanagement。0.4與其它管理體系的相容性CompatibilitywithothermanagementsystemsISO9001：2008質(zhì)量管理體制體系—要求ISO9001：2008Qualitymanagementsystems—Requirements0.4與其它管理體系的相容性為方便使用者,本標(biāo)準(zhǔn)在起草過程中適當(dāng)?shù)目紤]了ISO14001-2004標(biāo)準(zhǔn)的內(nèi)容,以增強(qiáng)兩類標(biāo)準(zhǔn)的相容性。附錄A表明了ISO9001—2008與ISO14001—2004之間的對應(yīng)關(guān)系。Duringthedevelopmentofthisinternationalstandard，dueconsiderationwasgiventotheprovisionofISO14001:2004toenhancethecompatibilityofthetwostandardsforbenefitoftheusercommunity.AnnexashowsthecorrespondencebetweenISO14001:2004.本國際標(biāo)準(zhǔn)不包括其它管理體系所規(guī)定的要求，例如環(huán)境管理,職業(yè)健康和安全管理，財(cái)務(wù)管理或風(fēng)險(xiǎn)管理。然而本國際標(biāo)準(zhǔn)能夠使組織的質(zhì)量管理體系與有關(guān)的管理體系要求相互結(jié)合或一體化。組織為了建立符合本國際標(biāo)準(zhǔn)要求的質(zhì)量管理體系，有可能會改變其現(xiàn)有的管理體系。ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems，suchasthoseparticulartoenvironmentalmanagement,occupationalhealthandsafetymanagement，financialmanagementorriskmanagement.However,thisInternationalStandardenablesanorganizationtoalignorintegrateitsownqualitymanagementsystemwithrelatedmanagementsystemrequirements.Itispossibleforanorganizationtoadaptitsexistingmanagementsystem（s）inordertoestablishaqualitymanagementsystemthatcomplieswiththerequirementsofthisInternationalStandard。0。5ISO/TS16949的目的GoalofthisTechnicalSpecification本技術(shù)規(guī)范的目標(biāo)是在供應(yīng)鏈中建立持續(xù)改進(jìn),強(qiáng)調(diào)缺陷預(yù)防，減少變差和浪費(fèi)的質(zhì)量管理體系。ThegoalofthisTechnicalSpecificationisthedevelopmentofaqualitymanagementsystemthatprovidesforcontinualimprovement,emphasizingdefectpreventionandthereductionofvariationandwasteinthesupplychain.本技術(shù)規(guī)范與適當(dāng)?shù)念櫩吞厥庖笙嘟Y(jié)合，規(guī)定了簽署本文件顧客的基本質(zhì)量管理體系要求.ThisTechnicalSpecification，coupledwithapplicablecustomer—specificrequirements，definesthefundamentalqualitymanagementsystemrequirementsforthosesubscribingtothisTechnicalSpecification。本技術(shù)規(guī)范旨在避免多重認(rèn)證審核，并為汽車生產(chǎn)件及服務(wù)件的組織建立質(zhì)量管理體系提供了一個通用的方法。ThisTechnicalSpecificationisintendedtoavoidmultiplecertificationauditsandprovideacommonapproachtoaqualitymanagementsystemforautomotiveproduction,andrelevantservicepartorganizations.質(zhì)量管理體系—-汽車行業(yè)生產(chǎn)件下相關(guān)服務(wù)件的組織實(shí)施ISO9001:2008的特殊要求Qualitymanagementsystems–ParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproduction,andrelevantservicepartorganizations1范圍Scope1。1總則GeneralISO9001：2008質(zhì)量管理體系—要求ISO9001：2008Qualitymanagementsystems—Requirements本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求：a）需要證實(shí)其具有穩(wěn)定地提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)品的能力；b）通過體系的有效應(yīng)用，包括體系持續(xù)改進(jìn)的過程的有效應(yīng)用,以及保證符合顧客與適用的法律法規(guī)要求，旨在增強(qiáng)顧客滿意.ThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization：a）Needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements;andb）Aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem，includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.注1：在本標(biāo)準(zhǔn)中,術(shù)語”產(chǎn)品"僅適用于:a）預(yù)期提供給顧客的或顧客所要求的產(chǎn)品；b）產(chǎn)品實(shí)現(xiàn)過程所產(chǎn)生的任何預(yù)期輸出。注2：法律法規(guī)要求可稱作法定要求。NOTE1：InthisInternationalStandard,theterm“product”onlyappliesto：a)productintendedfor，orrequiredby，acustomer；b）Andintendedoutputresultingfromtheproductrealizationprocesses。Note2：Statutoryandregulatoryrequirementscanbeexpressedaslegalrequirements。本技術(shù)規(guī)范與ISO9001:2008相結(jié)合，規(guī)定了質(zhì)量管理體系要求，用于汽車相關(guān)產(chǎn)品的設(shè)計(jì)和開發(fā)、生產(chǎn)，相關(guān)時，也適用于安裝和服務(wù)。ThisTechnicalSpecification，inconjunctionwithISO9001：2008，definesthequalitymanagementsystemrequirementsforthedesignanddevelopment,productionand，whenrelevant，installationandserviceofautomotive—relatedproducts。本技術(shù)規(guī)范適用于組織進(jìn)行顧客指定產(chǎn)品和/或服務(wù)零件的制造現(xiàn)場。ThisTechnicalSpecificationisapplicabletositesoftheorganizationwherecustomer—specifiedparts,forproductionand/orservice,aremanufactured.“支持功能",無論其在現(xiàn)場或外部場所（如設(shè)計(jì)中心、公司總部及分銷中心），由于它們對現(xiàn)場的支持性而構(gòu)成現(xiàn)場審核的一部分，但不能獲得本技術(shù)規(guī)范的認(rèn)證。Supportingfunctionswhetheron—siteorremote(suchasdesigncenters,corporateheadquartersanddistributioncenters），formpartofthesiteauditastheysupportthesite，butcannotobtainstand-alonecertificationtothisTechnicalSpecification。本技術(shù)規(guī)范可適用于整個汽車供應(yīng)鏈.ThisTechnicalSpecificationcanbeappliedthroughouttheautomotivesupplychain.1.2應(yīng)用ApplicationISO9001:2008質(zhì)量管理體制體系—要求ISO9001:2008Qualitymanagementsystems—Requirements1。2應(yīng)用Application本標(biāo)準(zhǔn)規(guī)定的所有要求是通用的，旨在適用于各種類型、不同規(guī)模和提供不同產(chǎn)品的組織.AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations，regardlessoftype,sizeandproductprovided。當(dāng)本標(biāo)準(zhǔn)的任何要求因組織及其產(chǎn)品的特點(diǎn)不適用時，可以考慮對其進(jìn)行刪減。Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.如果進(jìn)行刪減,應(yīng)僅限于本標(biāo)準(zhǔn)第7章的要求，并且這樣的刪減不影響組織提供滿足顧客要求和適用法律法規(guī)要求的產(chǎn)品的能力或責(zé)任,否則不能聲稱符合本標(biāo)準(zhǔn)。Whereexclusionsaremade，claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.本技術(shù)規(guī)范僅允許組織在沒有產(chǎn)品設(shè)計(jì)和開發(fā)責(zé)任的情況下刪減與7.3有關(guān)的內(nèi)容不允許刪減制造過程設(shè)計(jì)。TheonlypermittedexclusionsforthisTechnicalSpecificationrelateto7。3wheretheorganizationisnotresponsibleforproductdesignanddevelopment.Permittedexclusionsdonotincludemanufacturingprocessdesign.2規(guī)范性引用文件NormativereferenceISO9001：2008質(zhì)量管理體制體系—要求ISO9001:2008Qualitymanagementsystems—Requirements下列文件的條款通過本標(biāo)準(zhǔn)的引用而成為本標(biāo)準(zhǔn)的條款。凡是注日期的引用文件,其隨后所有的修改單（不包括勘誤的內(nèi)容)或修訂版均不適用于本標(biāo)準(zhǔn),然而，鼓勵根據(jù)本標(biāo)準(zhǔn)達(dá)成協(xié)議的各方研究是否可使用這些文件的最新版本。凡是不注日期的引用文件，其最新版本適用于本標(biāo)準(zhǔn)。ISO9000—2005質(zhì)量管理體系—基礎(chǔ)和術(shù)語。Thefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocument。Fordatedreferences，onlytheeditioncitedapplies.Forundatedreferences，thelatesteditionofthereferenceddocument（includinganyamendments）applies。ISO9000:2005Qualitymanagementsystems—Fundamentalsandvocabulary.3術(shù)語和定義TermsanddefinitionsISO9000:2008質(zhì)量管理體系—要求ISO9001:2008Qualitymanagementsystems—Requirements本標(biāo)準(zhǔn)采用ISO9000中所確立的術(shù)語和定義.ForthepurposesofthisdocumentthetermsanddefinitionsgiveninISO9000apply。本標(biāo)準(zhǔn)中所有出現(xiàn)的術(shù)語“產(chǎn)品”之處，也可指“服務(wù)"。ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs，itcanalsomean“service”.3.1汽車行業(yè)術(shù)語和定義Termsanddefinitionsfortheautomotiveindustry本文件應(yīng)用了ISO9001：2005以及下列內(nèi)容中所確立的術(shù)語和定義。Forthepurposesofthisdocument，thetermsanddefinitionsgiveninISO9000：2005andthefollowingapply。3.1.1?？刂朴?jì)劃controlplan對控制產(chǎn)品所要求的系統(tǒng)和過程的形成文件的描述。注：見附錄ADocumenteddescriptionofthesystemsandprocessesrequiredforcontrollingproduct。Note:seeannexA3.1。2。具有設(shè)計(jì)責(zé)任的組織designresponsibleorganization有權(quán)制定一個新的或更改現(xiàn)有的產(chǎn)品規(guī)范的組織.Organizationwithauthoritytoestablishaneworchangeanexistingproductspecification.注：該職責(zé)包括在顧客指定的應(yīng)用范圍內(nèi)試驗(yàn)并驗(yàn)證設(shè)計(jì)性能.NOTE：Thisresponsibilityincludestestingandverificationofdesignperformancewithinthecustomer'sspecifiedapplication.3.1。3防錯errorproofing為防止制造不合格產(chǎn)品而進(jìn)行的產(chǎn)品和制造過程的設(shè)計(jì)和開發(fā)。Productandmanufacturingprocessdesignanddevelopmenttopreventmanufactureofnon-conformingproducts.3。1。4實(shí)驗(yàn)室laborato