ISO-TS16949：2009質(zhì)量管理體系中英文對(duì)照版培訓(xùn)資料

1、Good is good, but better carries it.精益求精，善益求善。ISO-TS16949：2009質(zhì)量管理體系中英文對(duì)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QualitymanagementsystemsParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproductionandrelevantservicepartorganizations目錄Contents

2、前言Foreword7有關(guān)認(rèn)證的說(shuō)明Remarksforcertification9引言Introduction100.1總則General100.2過(guò)程方法Processapproach110.3與ISO9004的關(guān)系RelationshipwithISO9004130.4與其他管理體系的相容性Compatibilitywithothermanagementsystems140.5本技術(shù)規(guī)范的目的GoalofthisTechnicalSpecification151范圍Scope161.1總則General161.2應(yīng)用Application172引用標(biāo)準(zhǔn)Normativereference

3、173術(shù)語(yǔ)和定義Termsanddefinitions183.1汽車行業(yè)術(shù)語(yǔ)和定義Termsanddefinitionsfortheautomotiveindustry184質(zhì)量管理體系Qualitymanagementsystem204.1總要求Generalrequirements204.1.1總要求補(bǔ)充GeneralrequirementsSupplemental214.2文件要求Documentationrequirements214.2.1總則General214.2.2質(zhì)量手冊(cè)Qualitymanual224.2.3文件控制Controlofdocuments22工程規(guī)范Engin

4、eeringspecifications234.2.4記錄控制Controlofrecords23記錄保存Recordsretention245管理職責(zé)Managementresponsibility245.1管理承諾Managementcommitment245.1.1過(guò)程效率Processefficiency245.2以顧客為關(guān)注焦點(diǎn)Customerfocus245.3質(zhì)量方針Qualitypolicy255.4策劃Planning255.4.1質(zhì)量目標(biāo)Qualityobjectives25質(zhì)量目標(biāo)補(bǔ)充QualityobjectivesSupplemental255.4.2質(zhì)量管理體系的策

5、劃Qualitymanagementsystemplanning265.5職責(zé)、權(quán)限與溝通Responsibility,authorityandcommunication265.5.1職責(zé)和權(quán)限Responsibilityandauthority26質(zhì)量職責(zé)Responsibilityforquality265.5.2管理者代表Managementrepresentative27顧客代表Customerrepresentative275.5.3內(nèi)部溝通Internalcommunication275.6管理評(píng)審Managementreview275.6.1總則General27質(zhì)量管理體系績(jī)效

6、Qualitymanagementsystemperformance285.6.2評(píng)審輸入Reviewinput28評(píng)審輸入補(bǔ)充ReviewinputSupplemental285.6.3評(píng)審輸出Reviewoutput296資源管理Resourcemanagement296.1資源提供Provisionofresources296.2人力資源Humanresources296.2.1總則General306.2.2能力、培訓(xùn)和意識(shí)Competence,trainingandawareness30產(chǎn)品設(shè)計(jì)技能Productdesignskills30培訓(xùn)Training31崗位培訓(xùn)31員工的激

7、勵(lì)Employeemotivationandempowerment316.3基礎(chǔ)設(shè)施Infrastructure316.3.1工廠、設(shè)施和設(shè)備策劃Plant,facilityandequipmentplanning326.3.2應(yīng)急計(jì)劃Contingencyplans326.4工作環(huán)境Workenvironment326.4.1為達(dá)成產(chǎn)品要求符合性的人員安全Personnelsafetytoachieveconformityproductrequirements326.4.2生產(chǎn)現(xiàn)場(chǎng)的清潔Cleanlinessofpremises327產(chǎn)品實(shí)現(xiàn)Productrealization337.1產(chǎn)品

8、實(shí)現(xiàn)的策劃Planningofproductrealization337.1.1產(chǎn)品實(shí)現(xiàn)的策劃補(bǔ)充PlanningofproductrealizationSupplemental347.1.2接收準(zhǔn)則Acceptancecriteria347.1.3保密性Confidentiality347.1.4更改控制Changecontrol347.2與顧客有關(guān)的過(guò)程Customer-relatedprocesses347.2.1與產(chǎn)品有關(guān)的要求的確Determinationofrequirementsrelatedtotheproduct35顧客指定的特殊特性Customer-designatedsp

9、ecialcharacteristics357.2.2與產(chǎn)品有關(guān)的要求的評(píng)審Reviewofrequirementsrelatedtotheproduct35與產(chǎn)品有關(guān)的要求的評(píng)審補(bǔ)充ReviewofrequirementsrelatedtotheproducSupplemental36組織制造可行性O(shè)rganizationmanufacturingfeasibility367.2.3顧客溝通Customercommunication36顧客溝通補(bǔ)充CustomercommunicationSupplemental377.3設(shè)計(jì)和開發(fā)Designanddevelopment377.3.1設(shè)計(jì)和

10、開發(fā)策劃Designanddevelopmentplanning37多方論證方法Multidisciplinaryapproach377.3.2設(shè)計(jì)和開發(fā)輸入Designanddevelopmentinputs38產(chǎn)品設(shè)計(jì)輸入Productdesigninput38制造過(guò)程設(shè)計(jì)輸入Manufacturingprocessdesigninput39特殊特性Specialcharacteristics397.3.3設(shè)計(jì)和開發(fā)輸出Designanddevelopmentoutputs39產(chǎn)品設(shè)計(jì)輸出補(bǔ)充ProductdesignoutputsSupplemental40制造過(guò)程設(shè)計(jì)輸出Manufac

11、turingprocessdesignoutput407.3.4設(shè)計(jì)和開發(fā)評(píng)審Designanddevelopmentreview41監(jiān)視Monitoring417.3.5設(shè)計(jì)和開發(fā)驗(yàn)證Designanddevelopmentverification427.3.6設(shè)計(jì)和開發(fā)確認(rèn)Designanddevelopmentvalidation42設(shè)計(jì)和開發(fā)確認(rèn)補(bǔ)充DesignanddevelopmentvalidationSupplemental42樣件計(jì)劃Prototypeprogramme42產(chǎn)品批準(zhǔn)過(guò)程Productapprovalprocess437.3.7設(shè)計(jì)和開發(fā)更改的控制Control

12、ofdesignanddevelopmentchanges437.4采購(gòu)Purchasing437.4.1采購(gòu)過(guò)程Purchasingprocess44法規(guī)符合性Regulatoryconformity44供方質(zhì)量管理體系開發(fā)Supplierqualitymanagementsystemdevelopment44顧客批準(zhǔn)的供方Customer-approvedsources447.4.2采購(gòu)信息Purchasinginformation457.4.3采購(gòu)產(chǎn)品的驗(yàn)證Verificationofpurchasedproduct45進(jìn)貨產(chǎn)品對(duì)要求的符合性Incomingproductconformi

13、tytorequirements45對(duì)供方監(jiān)視Suppliermonitoring467.5生產(chǎn)和服務(wù)提供Productionandserviceprovision467.5.1生產(chǎn)和服務(wù)提供的控制Controlofproductionandserviceprovision46控制計(jì)劃Controlplan47作業(yè)指導(dǎo)書Workinstructions47作業(yè)準(zhǔn)備驗(yàn)證Verificationofjobsetups47預(yù)防性和預(yù)見性維護(hù)Preventiveandpredictivemaintenance48生產(chǎn)工裝的管理Managementofproductiontooling48生產(chǎn)計(jì)劃Pro

14、ductionscheduling49服務(wù)信息反饋Feedbackofinformationfromservice49與顧客的服務(wù)協(xié)議Serviceagreementwithcustomer497.5.2生產(chǎn)和服務(wù)提供過(guò)程的確認(rèn)Validationofprocessesforproductionandserviceprovision49生產(chǎn)和服務(wù)提供過(guò)程的確認(rèn)補(bǔ)充ValidationofprocessesforproductionandserviceprovisionSupplemental507.5.3標(biāo)識(shí)和可追溯性Identificationandtraceability50標(biāo)識(shí)和可追溯性

15、補(bǔ)充IdentificationandtraceabilitySupplemental507.5.4顧客財(cái)產(chǎn)Customerproperty51顧客所有的工裝Customer-ownedproductiontooling517.5.5.產(chǎn)品防護(hù)Preservationofproduct51貯存和庫(kù)存Storageandinventory517.6監(jiān)視和測(cè)量設(shè)備的控制Controlofmonitoringandmeasuringequipment527.6.1測(cè)量系統(tǒng)分析Measurementsystemanalysis537.6.2校準(zhǔn)/驗(yàn)證記錄Calibration/verification

16、records537.6.3實(shí)驗(yàn)室要求Laboratoryrequirements53內(nèi)部實(shí)驗(yàn)室Internallaboratory53外部實(shí)驗(yàn)室Externallaboratory548測(cè)量、分析和改進(jìn)Measurement,analysisandimprovement548.1總則General558.1.1統(tǒng)計(jì)工具的確定Identificationofstatisticaltools558.1.2基礎(chǔ)統(tǒng)計(jì)概念知識(shí)Knowledgeofbasicstatisticalconcepts558.2監(jiān)視和測(cè)量Monitoringandmeasurement558.2.1顧客滿意Customers

17、atisfaction55顧客滿意補(bǔ)充CustomersatisfactionSupplemental568.2.2內(nèi)部審核Internalaudit56質(zhì)量管理體系審核Qualitymanagementsystemaudit57制造過(guò)程審核Manufacturingprocessaudit57產(chǎn)品審核Productaudit57內(nèi)部審核計(jì)劃Internalauditplans57內(nèi)審員資格Internalauditorqualification578.2.3過(guò)程的監(jiān)視和測(cè)量Monitoringandmeasurementofprocesses58制造過(guò)程的監(jiān)視和測(cè)量Monitoringand

18、measurementofmanufacturingprocesses588.2.4產(chǎn)品的監(jiān)視和測(cè)量Monitoringandmeasurementofproduct59全尺寸檢驗(yàn)和功能試驗(yàn)Layoutinspectionandfunctionaltesting59外觀項(xiàng)目Appearanceitems608.3不合格品控制Controlofnonconformingproduct608.3.1不合格品控制補(bǔ)充ControlofnonconformingproductSupplemental618.3.2返工產(chǎn)品的控制Controlofreworkedproduct618.3.3顧客通知Cus

19、tomerinformation618.3.4顧客特許Customerwaiver618.4數(shù)據(jù)分析Analysisofdata618.4.1數(shù)據(jù)分析和使用Analysisanduseofdata628.5改進(jìn)Improvement628.5.1持續(xù)改進(jìn)Continualimprovement62組織的持續(xù)改進(jìn)Continualimprovementoftheorganization62制造過(guò)程的改進(jìn)Manufacturingprocessimprovement628.5.2糾正措施Correctiveaction63解決問(wèn)題的方法Problemsolving63防錯(cuò)Error-proofin

20、g63糾正措施影響Correctiveactionimpact63拒收產(chǎn)品的試驗(yàn)/分析Rejectedproducttest/analysis638.5.3預(yù)防措施Preventiveaction64附錄A控制計(jì)劃AnnexA(normative)Controlplan65參考文獻(xiàn)Bibliography67前言Foreword國(guó)際標(biāo)準(zhǔn)化組織(ISO)是由各國(guó)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(huì)。國(guó)際標(biāo)準(zhǔn)的擬定由ISO技術(shù)委員會(huì)負(fù)責(zé)。各成員機(jī)構(gòu)若對(duì)某技術(shù)委員會(huì)所選定的主題感興趣，均有權(quán)參加該委員會(huì)的工作。與ISO保持聯(lián)系的各國(guó)組織(官方的或非官方的)也可參加該項(xiàng)工作。ISO與國(guó)際電器

21、委員會(huì)（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.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbe

22、enestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.本國(guó)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

23、。InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.技術(shù)委員會(huì)的主要任務(wù)是制定國(guó)際標(biāo)準(zhǔn)。本國(guó)際技術(shù)標(biāo)準(zhǔn)草案已由技術(shù)委員會(huì)通過(guò)，并傳閱各成員機(jī)構(gòu)一共投票表決。國(guó)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.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecir

24、culatedtothememberbodiesforvoting.Publicationasaninternationalstandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.在其它情況下，特別是在市場(chǎng)急需某個(gè)文件時(shí)，技術(shù)委員會(huì)可以決定出版其他形式的規(guī)范文件：Inothercircumstances,particularlywhenthereisanurgentmarketrequirementforsuchdocuments,atechnicalcommitteemaydecidetopublishotherty

25、pesofnormativedocument:ISO公布的可獲得規(guī)范（ISO/PAS）代表一項(xiàng)在一個(gè)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(huì)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

26、技術(shù)規(guī)范（ISO/TS），是技術(shù)委員會(huì)成員之間達(dá)成的協(xié)議，在委員會(huì)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(guó)際汽車工業(yè)特別行動(dòng)小組（IATF），在ISO/TC176質(zhì)量管理和質(zhì)量保證技術(shù)委員會(huì)支持下制定的。IS

27、O/TS16949waspreparedbytheInternationalAutomotiveTaskForce(IATF)withsupportfromISO/TC176,Qualitymanagementandqualityassurance.通過(guò)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),whichhasbeentechnicallyamen

28、dedaccordingtoISO9001:2008.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(duì)理解或澄清相關(guān)要求的指南。InthisTechnicalSpecification,theword“shall”indicatesarequirement.Th

29、eword“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(shuō)明

30、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(guó)際汽車推動(dòng)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(huì)(ANFIA)www.anfia.it美國(guó)國(guó)際汽車監(jiān)督署(IAOB)IATF-F英國(guó)汽車制造與貿(mào)易商謝(SMMT)www.smmt.co.uk德國(guó)汽車工業(yè)協(xié)會(huì)-質(zhì)量管理中心(VDA-QMC)www.vda-qmc.deThecertificationtothisTechnicalSpecification,includingcustome

31、r-specificrequirementsifany,isrecognizedbythecustomermembersofIATFwhenachievedaccordingtotheIATFcertificationscheme(seethe“RulesforachievingIATFrecognition”).DetailscanbeobtainedattheaddressesofthelocaloversightofficesofIATFcitedbelow:AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIA)Website:w

32、ww.anfia.itInternationalAutomotiveOversightBureau(IAOB)Website:IATF-FranceWebsite: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ISO9001:2008Qua

33、litymanagementsystemsRequirements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(gè)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.Thedesignandimplementationofanorganizationsqualitymanagementsystemisinfluencedby: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

34、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(guò)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。Itis

35、nottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.本標(biāo)準(zhǔn)規(guī)定的質(zhì)量管理體系要求是對(duì)產(chǎn)品要求的補(bǔ)充?！白ⅰ笔抢斫夂驼f(shuō)明有關(guān)要求的指南。ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked.“

36、NOTE”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(píng)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,toassesstheorganizationsabilitytomeetcustomer,regulatoryandtheorganizationsownrequireme

37、nts.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(guò)程方法ProcessapproachISO9001:2008質(zhì)量管理體制體系要求ISO9001:2008QualitymanagementsystemsRequirements本標(biāo)準(zhǔn)鼓勵(lì)在建立、實(shí)施質(zhì)量管理體系以及在改進(jìn)其有效性時(shí)采用

38、過(guò)程方法，通過(guò)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(dòng)。通過(guò)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(dòng)，可視為一個(gè)過(guò)程，通常，一個(gè)過(guò)程的輸出直接形成

39、下一個(gè)過(guò)程的輸入。Foranorganizationtofunctioneffectively,ithastodetermineandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.為了產(chǎn)生期望的結(jié)果，由過(guò)程組成的系統(tǒng)在組織內(nèi)的應(yīng)用，連同這些

40、過(guò)程的識(shí)別和相互作用，以及對(duì)這些過(guò)程的管理，可稱之為“過(guò)程方法”。Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagementtoproducethedesiredoutcome,canbereferredtoasthe“processapproach”.過(guò)程方法的一個(gè)優(yōu)點(diǎn)是對(duì)過(guò)程系統(tǒng)中單個(gè)過(guò)程之間的聯(lián)系以及過(guò)程的組合和相互作用進(jìn)行連續(xù)的控制。Anadvantageoftheprocess

41、approachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteraction.在質(zhì)量管理體系應(yīng)用過(guò)程方法時(shí)，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(guò)程；c)獲得過(guò)程績(jī)效和有效性的結(jié)果；d)在客觀測(cè)量的基礎(chǔ)上，持續(xù)改進(jìn)過(guò)程。Whenusedwithinaqualitymanagementsystem,suchanapproachemphasi

42、zestheimportanceof:a)Understandingandfulfillingrequirements;b)Theneedtoconsiderprocessesintermsofaddedvalue;c)Obtainingresultsofprocessperformanceandeffectiveness;andd)Continualimprovementofprocessesbasedonobjectivemeasurement.圖1所反映的以過(guò)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(guò)程聯(lián)系。該圖反映了在規(guī)定輸入要求時(shí)，顧客起著重要的作用。對(duì)顧客滿意的監(jiān)視

43、，要求組織對(duì)顧客關(guān)于組織是否已滿足其要求的感受信息進(jìn)行評(píng)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(guò)程。Themodelofaprocess-basedqualitymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinclauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputs.Monitoringofcustomersatisfactionrequiresthee

44、valuationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevel.注：此外，稱之為“PDCA”的方法可適用于所有過(guò)程。PDCA模式可簡(jiǎn)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(guò)程；D實(shí)施：實(shí)施過(guò)程

45、；C檢查：根據(jù)方針、目標(biāo)和產(chǎn)品要求，對(duì)過(guò)程和產(chǎn)品進(jìn)行監(jiān)視和測(cè)量，并報(bào)告結(jié)果；A處置：采取措施，以持續(xù)改進(jìn)過(guò)程業(yè)績(jī)。NOTE:Inaddition,themethodologyknownasPlan-Do-Check-Act(PDCA)canbeappliedtoallprocesses.PDCAcanbebrieflydescribedasfollows:Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganizationspo

46、licies;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ISO9001:2008QualitymanagementsystemsReq

47、uirements0.3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。ISO9001specif

48、iesrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.在本標(biāo)準(zhǔn)發(fā)布時(shí)，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，I

49、SO9004關(guān)注質(zhì)量管理的更寬范圍；通過(guò)系統(tǒng)和持續(xù)改進(jìn)組織的績(jī)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.

50、ISO9004providesawiderfocusonqualitymanagementthanISO9001;itaddressestheneedsandexpectationsofallinterestedpartiesandtheirsatisfaction,bythesystematicandcontinualimprovementoftheorganizationsperformance.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

51、和ISO9004中涉及的八項(xiàng)質(zhì)量管理原則的知識(shí)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ISO9001:2008Qualitymanagementsy

52、stemsRequirements0.4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(guò)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(duì)應(yīng)關(guān)系。Duringthedevelopmentofthisinternationalstandard,dueconsiderationwasgiventotheprovisionofISO14001:2004toenhancethecompatibilityofthetwostandardsforbenefitoftheusercommunity.Anne

53、xashowsthecorrespondencebetweenISO14001:2004.本國(guó)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(guó)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(guó)際標(biāo)準(zhǔn)要求的質(zhì)量管理體系，有可能會(huì)改變其現(xiàn)有的管理體系。ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseparticulartoenvironmentalmanagement,

54、occupationalhealthandsafetymanagement,financialmanagementorriskmanagement.However,thisInternationalStandardenablesanorganizationtoalignorintegrateitsownqualitymanagementsystemwithrelatedmanagementsystemrequirements.Itispossibleforanorganizationtoadaptitsexistingmanagementsystem(s)inordertoestablisha

55、qualitymanagementsystemthatcomplieswiththerequirementsofthisInternationalStandard。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,emphasizingde

56、fectpreventionandthereductionofvariationandwasteinthesupplychain.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)

57、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(gè)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QualitymanagementsystemsParticularrequire

58、mentsfortheapplicationofISO9001:2008forautomotiveproduction,andrelevantservicepartorganizations1范圍Scope1.1總則GeneralISO9001:2008質(zhì)量管理體系要求ISO9001:2008QualitymanagementsystemsRequirements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(guò)體系的有效應(yīng)用，包括體系持續(xù)改進(jìn)的過(guò)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。T

59、hisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization:a)Needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements;andb)Aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocesse

60、sforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.注1：在本標(biāo)準(zhǔn)中，術(shù)語(yǔ)”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(guò)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)Andint