IATF16949 中英文對照版 202310

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4組織的環(huán)境4.1理解組織及其環(huán)境見ISO9001:2023的要求。4Contextoftheorganization4.1UnderstandingtheorganizationanditscontextSeeISO9001:2023requirements.Theorganizationshalldetermineexternalandinternalissuesthatarerelevanttoitspurposeanditsstrategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsqualitymanagementsystem.Theorganizationshallmonitorandreviewinformationabouttheseexternalandinternalissues.NOTE1Issuescanincludepositiveandnegativefactorsorconditionsforconsideration.NOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringissuesarisingfromlegal,technological,competitive,market,cultural,socialandeconomicenvironments,whetherinternational,national,regionalorlocal.NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelatedtovalues,culture,knowledgeandperformanceoftheorganization.組織應(yīng)確定與其目標(biāo)和戰(zhàn)略方向相關(guān)并影響實(shí)現(xiàn)其質(zhì)量管理體系預(yù)期結(jié)果的各種外部和內(nèi)部因素。組織應(yīng)對這些內(nèi)部和外部因素的相關(guān)信息進(jìn)行監(jiān)視和評審。注1：這些因素可以包括需要考慮的正面或負(fù)面的因素或條件；注2：可以通過考慮源于國際、國家、地區(qū)或本地的各種法律法規(guī)、技術(shù)、競爭、市場、文化、社會和經(jīng)濟(jì)因素的狀況，有助于理解外部環(huán)境。注3：可以通過考慮組織的價值觀、文化、知識和組織績效等相關(guān)因素狀況，有助于理解內(nèi)部環(huán)境。4.2理解相關(guān)方的需求和期望見ISO9001:2023的要求。4.2UnderstandingtheneedsandexpectationsofinterestedpartiesSeeISO9001:2023requirements.Duetotheireffectorpotentialeffectontheorganization’sabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements,theorganizationshalldetermine:a)theinterestedpartiesthatarerelevanttothequalitymanagementsystem;b)therequirementsoftheseinterestedpartiesthatarerelevanttothequalitymanagementsystem.Theorganizationshallmonitorandreviewinformationabouttheseinterestedpartiesandtheirrelevantrequirements.由于相關(guān)方對組織持續(xù)提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)品和服務(wù)的能力產(chǎn)生影響或潛在影響，因此，組織應(yīng)確定：a)與質(zhì)量管理體系有關(guān)的相關(guān)方；b)這些相關(guān)方的要求。組織應(yīng)對這些相關(guān)方及其要求的相關(guān)信息進(jìn)行監(jiān)視和評審。4.3確定質(zhì)量管理體系的范圍見ISO9001:2023的要求。4.3DeterminingthescopeofthequalitymanagementsystemSeeISO9001:2023requirements.Theorganizationshalldeterminetheboundariesandapplicabilityofthequalitymanagementsystemtoestablishitsscope.Whendeterminingthisscope,theorganizationshallconsider:a)theexternalandinternalissuesreferredtoin4.1;b)therequirementsofrelevantinterestedpartiesreferred組織應(yīng)確定質(zhì)量管理體系的邊界和適用性，以確定其范圍。在確定質(zhì)量管理體系范圍時，組織應(yīng)考慮：a)在4.1中涉及的各種外部和內(nèi)部因素；b)在4.2中涉及的有關(guān)相關(guān)方要求；c)組織的產(chǎn)品與服務(wù)。對于本標(biāo)準(zhǔn)中適用于組織確定的質(zhì)量管理體系范圍的全部要求，組織應(yīng)予以實(shí)施。組織的質(zhì)量管理體系范圍應(yīng)作為形成文件的信息加以保持。該范圍應(yīng)說明質(zhì)量管理體系所覆蓋的產(chǎn)品和服務(wù)類型，若組織認(rèn)為其管理體系范圍的應(yīng)用范圍不適用本標(biāo)準(zhǔn)的某些要求，應(yīng)說明理由。那些不適用組織的質(zhì)量管理體系要求，不能影響組織確保產(chǎn)品和服務(wù)合格以及加強(qiáng)顧客滿意的能力或責(zé)任，否則不能聲稱符合本標(biāo)準(zhǔn)的要求。toin4.2;c)theproductsandservicesoftheorganization.TheorganizationshallapplyalltherequirementsofthisInternationalStandardiftheyareapplicablewithinthedeterminedscopeofitsqualitymanagementsystem.Thescopeoftheorganization’squalitymanagementsystemshallbeavailableandbemaintainedasdocumentedinformation.Thescopeshallstatethetypesofproductsandservicescovered,andprovidejustificationforanyrequirementofthisInternationalStandardthattheorganizationdeterminesisnotapplicabletothescopeofitsqualitymanagementsystem.ConformitytothisInternationalStandardmayonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonotaffecttheorganization’sabilityorresponsibilitytoensuretheconformityofitsproductsandservicesandtheenhancementofcustomersatisfaction.4.3.1確定質(zhì)量管理體系的范圍補(bǔ)充4.3.1Determiningthescopeofthequalitymanagementsystem-supplementalwhetheron-siteorremote（such支持功能，無論其在現(xiàn)場或外部場所（例如：設(shè)計(jì)Supportingfunctions，中心、公司總部和配送中心），應(yīng)包含在質(zhì)量管理體asdesigncentres，corporateheadquarters，and系（QMS）的范圍中。distributioncentres），shallbeincludedinthescopeoftheQualityManagementSystem（QMS）.本汽車QMS標(biāo)準(zhǔn)唯一允許的刪減是ISO9001第8.3條中的產(chǎn)品設(shè)計(jì)和開發(fā)要求。刪減應(yīng)以形成文件的信息（見ISO9001第7.5條）的形式進(jìn)行證明和保持。允許的刪減不包括制造過程設(shè)計(jì)。4.3.2顧客特定要求應(yīng)對顧客特定要求進(jìn)行評價，并將其包含在組織的質(zhì)量管理體系范圍內(nèi)。TheonlypermittedexclusionforthisAutomotiveQMSStandardrelatestotheproductdesignanddevelopmentrequirementswithinISO9001，Section8.3.Theexclusionshallbejustifiedandmaintainedasdocumentedinformation（seeISO9001，Section7.5）.Permittedexclusionsdonotincludemanufacturingprocessdesign.4.3.2Customer-specificrequirementsCustomer-specificrequirementsshallbeevaluatedandincludedinthescopeoftheorganization’squalitymanagementsystem.4.4Qualitymanagementsystemanditsprocesses4.4.1SeeISO9001:2023requirements4.4.1Theorganizationshallestablish,implement,maintainandcontinuallyimproveaqualitymanagementsystem,includingtheprocessesneededandtheirinteractions,in4.4質(zhì)量管理體系及其過程4.4.1見ISO9001:2023的要求。4.4.1組織應(yīng)按本標(biāo)準(zhǔn)的要求建立、實(shí)施、保持和持續(xù)改進(jìn)質(zhì)量管理體系，包括質(zhì)量管理體系所需的過程及其相互作用。組織應(yīng)確定質(zhì)量管理體系所需的過程及其在整個組織中的應(yīng)用，組織應(yīng)：a)確定這些過程所需的輸入和期望的輸出；b)確定這些過程的順序和相互作用；c)確定和應(yīng)用所需的準(zhǔn)則和方法（包括監(jiān)視、測量和相關(guān)的績效指標(biāo)），以確保這些過程的有效運(yùn)行和控制；d)確定并確保獲得這些過程所需的資源；e)規(guī)定與這些過程相關(guān)的責(zé)任和權(quán)限；f)應(yīng)依照6.1的要求確定風(fēng)險(xiǎn)和機(jī)遇；g)評價這些過程，實(shí)施所需的更改，以確保這些過程實(shí)現(xiàn)預(yù)期的結(jié)果；h)改進(jìn)過程和質(zhì)量管理體系。產(chǎn)品和過程的符合性組織應(yīng)確保所有的產(chǎn)品和過程，包括服務(wù)件及外包的產(chǎn)品和過程，符合一切適用的顧客和法律法規(guī)要求（見條）。產(chǎn)品安全組織應(yīng)有形成文件的過程，用于與產(chǎn)品安全有關(guān)的產(chǎn)品和制造過程管理；形成文件的過程包括但不限于（在適用狀況下）：a）組織應(yīng)對產(chǎn)品安全法律法規(guī)要求的識別；b）向顧客通知a）項(xiàng)中的要求；c）設(shè)計(jì)FMEA的特別批準(zhǔn)；d）產(chǎn)品安全相關(guān)特性的識別；e）產(chǎn)品及制造時安全相關(guān)特性的識別和控制；f）控制計(jì)劃和過程FMEA的特別批準(zhǔn)；g）反應(yīng)計(jì)劃（見第條）；h）包括最高管理者在內(nèi)的，明確的職責(zé)，升級過程和信息流的定義，以及顧客通知；i）組織或顧客為與產(chǎn)品安全有關(guān)的產(chǎn)品和相關(guān)制造過程中涉及的人員確定的培訓(xùn)；accordancewiththerequirementsofthisInternationalStandard.Theorganizationshalldeterminetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization,andshall:a)determinetheinputsrequiredandtheoutputsexpectedfromtheseprocesses;b)determinethesequenceandinteractionoftheseprocesses;c)determineandapplythecriteriaandmethods(includingmonitoring,measurementsandrelatedperformanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;d)determinetheresourcesneededfortheseprocessesandensuretheiravailability;e)assigntheresponsibilitiesandauthoritiesfortheseprocesses;f)addresstherisksandopportunitiesasdeterminedinaccordancewiththerequirementsof6.1;g)evaluatetheseprocessesandimplementanychangesneededtoensurethattheseprocessesachievetheirintendedresults;h)improvetheprocessesandthequalitymanagementsystem.ConformanceofproductsandprocessesTheorganizationshallensureconformanceofallproductsandprocesses，includingservicepartsandthosethatareoutsourced，toallapplicablecustomer，statutory，andregulatoryrequirements（seeSection）.ProductsafetyTheorganizationshallhavedocumentedprocessesforthemanagementofproduct-safetyrelatedproductsandmanufacturingprocesses，whichshallincludebutnotbelimitedtothefollowing，whereapplicable:a）identificationbytheorganizationofstatutoryandregulatoryproduct-safetyrequirements；b）customernotificationofrequirementsinitema）；c）specialapprovalsfordesignFMEA；d）identificationofproductsafety-relatedcharacteristics；e）identificationandcontrolsofsafety-relatedj）產(chǎn)品或過程的更改在實(shí)施之前應(yīng)獲得批準(zhǔn)，包括對過程和產(chǎn)品更改帶給產(chǎn)品安全的潛在影響進(jìn)行評價（見ISO9001第8.3.6條）；k）整個供應(yīng)鏈中關(guān)于產(chǎn)品安全的要求轉(zhuǎn)移，包括顧客指定的貨源（見第條）；l）整個供應(yīng)鏈中按制造批次（至少）的產(chǎn)品可追溯性（見第條）；m）為新產(chǎn)品導(dǎo)入的經(jīng)驗(yàn)教訓(xùn)。注：顧客或者組織內(nèi)部程序可要求與安全相關(guān)的要求或者文件的特別批準(zhǔn)。characteristicsofproductandatthepointofmanufacture；f）specialapprovalofcontrolplansandprocessFMEAs；g）reactionplans（seeSection）；h）definedresponsibilities，definitionofescalationprocessandflowofinformation，includingtopmanagement，andcustomernotification；i）trainingidentifiedbytheorganizationorcustomerforpersonnelinvolvedinproduct畫safetyrelatedproductsandassociatedmanufacturingprocesses；j）changesofproductorprocessshallbeapprovedpriortoimplementation，includingevaluationofpotentialeffectsonproductsafetyfromprocessandproductchanges（seeISO9001，Section8.3.6）；k）transferofrequirementswithregardtoproductsafetythroughoutthesupplychain，includingcustomer-designatedsources（seeSection）；l）producttraceabilitybymanufacturedlot（ataminimum）throughoutthesupplychain（seeSection）；m）lessonslearnedfornewproductintroduction.NOTE:Specialapprovalofsafetyrelatedrequirementsordocumentsmayberequiredbythecustomerortheorganization’sinternalprocesses.4.4.2SeeISO9001:2023requirements.4.4.2Totheextentnecessary,theorganizationshall:a)maintaindocumentedinformationtosupporttheoperationofitsprocesses;b)retaindocumentedinformationtohaveconfidencethattheprocessesarebeingcarriedoutasplanned.4.4.2在必要的程度上，組織應(yīng)：見ISO9001:2023的要求。a)保持形成文件的信息以支持過程運(yùn)行；b)保存確認(rèn)其過程是按計(jì)劃進(jìn)行的形成文件的信息。5領(lǐng)導(dǎo)作用5Leadership5.1Leadershipandcommitment5.1.1General

5.1領(lǐng)導(dǎo)作用與承諾SeeISO9001:2023requirements.5.1.1General總則5.1.1總則Topmanagementshalldemonstrateleadershipandcommitmentwithrespecttothequalitymanagement見ISO9001:2023的要求。systemby:最高管理者應(yīng)證明其對質(zhì)量管理體系的領(lǐng)導(dǎo)作用和a)takingaccountabilityfortheeffectivenessofthequality承諾，通過：managementsystem;a)對質(zhì)量管理體系的有效性承受責(zé)任；b)ensuringthatthequalitypolicyandqualityobjectivesb)確保制定質(zhì)量管理體系的質(zhì)量方針和質(zhì)量目標(biāo)，areestablishedforthequalitymanagementsystemandare并與組織環(huán)境和戰(zhàn)略方向保持一致；compatiblewiththecontextandstrategicdirectionofthec)確保將質(zhì)量管理體系要求融入組織的業(yè)務(wù)過程；organization;d)促進(jìn)使用過程方法和基于風(fēng)險(xiǎn)的思維；c)ensuringtheintegrationofthequalitymanagemente)確保獲得質(zhì)量管理體系所需的資源；systemrequirementsintotheorganization’sbusinessf)溝通有效的質(zhì)量管理體系和符合質(zhì)量管理體系要processes;求的重要性；d)promotingtheuseoftheprocessapproachandg)確保實(shí)現(xiàn)質(zhì)量管理體系的預(yù)期結(jié)果；risk-basedthinking;h)促使、指導(dǎo)和支持員工努力提高質(zhì)量管理體系的e)ensuringthattheresourcesneededforthequality有效性；managementsystemareavailable;i)推動改進(jìn)；f)communicatingtheimportanceofeffectivequalityj)支持其他管理者履行其相關(guān)領(lǐng)域的職責(zé)。managementandofconformingtothequalitymanagement注：本標(biāo)準(zhǔn)中的“業(yè)務(wù)〞一詞可大致理解為涉及組織存systemrequirements;在目的的核心價值活動，組織可以是公有的、私有g(shù))ensuringthatthequalitymanagementsystemachieves的、盈利或非盈利的。itsintendedresults;h)engaging,directingandsupportingpersonstocontributetotheeffectivenessofthequalitymanagementsystem;i)promotingimprovement;j)supportingotherrelevantmanagementrolestodemonstratetheirleadershipasitappliestotheirareasofresponsibility.NOTEReferenceto“business〞inthisInternationalStandardcanbeinterpretedbroadlytomeanthoseactivitiesthatarecoretothepurposesoftheorganization’sexistence,whethertheorganizationispublic,private,forprofitornotforprofit.公司責(zé)任CorporateresponsibilityTheorganizationshalldefineandimplementcorporateresponsibilitypolicies，includingata組織應(yīng)明確并實(shí)施公司責(zé)任方針，至少包括反賄賂minimumananti-briberypolicy，anemployeecodeof方針、員工行為準(zhǔn)則以及道德準(zhǔn)則升級政策（“舉報(bào)conduct，andanethicsescalationpolicy政策〞）。（“whistle-blowingpolicy〞）.ProcesseffectivenessandefficiencyTopmanagementshallreviewtheproductrealization過程有效性和效率processesandsupportprocessestoevaluateand最高管理者應(yīng)評審產(chǎn)品實(shí)現(xiàn)過程和支持過程，以評improvetheireffectivenessandefficiency.Theresultsoftheprocessreviewactivitiesshallbeincludedas價并改進(jìn)過程有效性和效率。過程評審活動的結(jié)果應(yīng)作為管理評審的輸入（見第條）。inputtothemanagementreview（seeSection.）.ProcessownersTopmanagementshallidentifyprocessownerswho過程擁有者areresponsibleformanagingtheorganization'sprocessesandrelatedoutputs.Processownersshall最高管理者應(yīng)確定過程擁有者，由其負(fù)責(zé)組織的各understandtheirrolesandbecompetenttoperform過程和相關(guān)輸出的管理。過程擁有者應(yīng)了解他們的thoseroles（seeISO9001，Section7.2）.角色，并且具備勝任其角色的能力（見ISO9001第7.2條）.5.1.2CustomerfocusSeeISO9001:2023requirements.5.1.2以顧客為關(guān)注焦點(diǎn)Topmanagementshalldemonstrateleadershipand見ISO9001:2023的要求。最高管理者應(yīng)通過以下方面，證明其對以顧客為關(guān)注焦點(diǎn)的領(lǐng)導(dǎo)作用和承諾：a)確定、理解和持續(xù)滿足顧客要求以及適用的法律和法規(guī)要求；b)確定和應(yīng)對能夠影響產(chǎn)品和服務(wù)符合性以及加強(qiáng)顧客滿意能力的風(fēng)險(xiǎn)與機(jī)遇；c)始終致力于加強(qiáng)顧客滿意。commitmentwithrespecttocustomerfocusbyensuringthat:a)customerandapplicablestatutoryandregulatoryrequirementsaredetermined,understoodandconsistentlymet;b)therisksandopportunitiesthatcanaffectconformityofproductsandservicesandtheabilitytoenhancecustomersatisfactionaredeterminedandaddressed;c)thefocusonenhancingcustomersatisfactionismaintained.5.2方針5.2.1建立質(zhì)量方針5.2Policy5.2.1EstablishingthequalifypolicySeeISO9001:2023requirements.Topmanagementshallestablish,implementandmaintainaqualitypolicythat:見ISO9001:2023的要求。a)isappropriatetothepurposeandcontextofthe最高管理者應(yīng)制定、實(shí)施和保持質(zhì)量方針，方針應(yīng)：organizationandsupportsitsstrategicdirection;a)與組織的宗旨和環(huán)境相適應(yīng)，并支持其戰(zhàn)略方向；b)providesaframeworkforsettingqualityobjectives;b)提供制定質(zhì)量目標(biāo)的框架c)includesacommitmenttosatisfyapplicablec)包括對滿足適用要求的承諾；requirements;d)包括對持續(xù)改進(jìn)質(zhì)量管理體系的承諾。d)includesacommitmenttocontinualimprovementofthequalitymanagementsystem.5.2.2CommunicatingthequalitypolicySeeISO9001:2023requirements.5.2.2溝通質(zhì)量方針見ISO9001:2023的要求。質(zhì)量方針應(yīng)：a)作為形成文件的信息，可獲得并保持；b)在組織內(nèi)得到溝通、理解和應(yīng)用c)適合時，可向有關(guān)相關(guān)方提供。Thequalitypolicyshall:a)beavailableandbemaintainedasdocumentedinformation;b)becommunicated,understoodandappliedwithintheorganization;c)beavailabletorelevantinterestedparties,asappropriate.5.3組織的作用、職責(zé)和權(quán)限見ISO9001:2023的要求。5.3Organizationalroles，responsibilitiesandauthoritiesSeeISO9001:2023requirements.Topmanagementshallensurethattheresponsibilitiesandauthoritiesforrelevantrolesareassigned,communicatedandunderstoodwithintheorganization.Topmanagementshallassigntheresponsibilityandauthorityfor:a)ensuringthatthequalitymanagementsystemconformstotherequirementsofthisInternationalStandard;b)ensuringthattheprocessesaredeliveringtheirintendedoutputs;c)reportingontheperformanceofthequalitymanagementsystemandonopportunitiesforimprovement(see10.1),inparticulartotopmanagement;d)ensuringthepromotionofcustomerfocusthroughouttheorganization;e)ensuringthattheintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.最高管理者應(yīng)確保相關(guān)角色的職責(zé)和權(quán)限在整個組織內(nèi)得到分派、溝通和理解。最高管理者應(yīng)分派職責(zé)和權(quán)限，以：a)確保質(zhì)量管理體系符合本標(biāo)準(zhǔn)的要求；b)確保各過程獲得其預(yù)期的輸出；c)報(bào)告質(zhì)量管理體系的績效和改進(jìn)機(jī)遇，特別向最高管理者；d)確保在整個組織推動以顧客為關(guān)注焦點(diǎn)；e)確保在計(jì)劃和實(shí)施質(zhì)量管理體系的更改時保持其完整性。Topmanagementshallassignpersonnelwiththe最高管理者應(yīng)向人員指派職責(zé)和權(quán)限，以確保顧客responsibilityandauthoritytoensurethatcustomer要求得到滿足。這些指派應(yīng)形成文件。這包括但不requirementsaremet.Theseassignmentsshallbe限于：特別特性的選擇，質(zhì)量目標(biāo)和相關(guān)培訓(xùn)的設(shè)documented.Thisincludesbutisnotlimitedtothe置，改正和預(yù)防措施，產(chǎn)品設(shè)計(jì)和開發(fā)，產(chǎn)能分析，selectionofspecialcharacteristics，settingquality物流信息，顧客計(jì)分卡以及顧客門戶。objectivesandrelatedtraining，correctiveandPreventiveactions，productdesignanddevelopment，capacityanalysis，logisticsinformation，customerscorecards，andcustomerportals.5.3.1組織的作用、職責(zé)和權(quán)限補(bǔ)充5.3.1Organizationalroles，responsibilities，andauthorities-supplemental5.3.2Responsibilityandauthorityforproductrequirementsandcorrectiveactions5.3.2產(chǎn)品要求和改正措施的職責(zé)和權(quán)限Topmanagementshallensurethat:最高管理者應(yīng)確保：a）personnelresponsibleforconformitytoa）負(fù)責(zé)產(chǎn)品要求符合性的人員有權(quán)中止發(fā)運(yùn)productrequirementshavetheauthoritytostop或生產(chǎn)以改正質(zhì)量問題；shipmentandstopproductiontocorrectquality注：由于一些行業(yè)中的過程設(shè)計(jì)，并非總是能馬上中止生產(chǎn)。在這種狀況下，必需對受problems；影響批次進(jìn)行控制，以防將其發(fā)運(yùn)給顧客。NOTEDuetotheprocessdesigninsomeindustries，itb）擁有改正措施權(quán)限和職責(zé)的人員能夠及時獲知與要求不符的產(chǎn)品或過程，以確保避免mightnotalwaysbepossibletostopproductionimmediately.Inthiscase，theaffectedbatchmustbe將不合格品發(fā)運(yùn)給顧客，并確保所有潛在不containedandshipmenttothecustomerprevented.合格品得到識別與控制；b）personnelwithauthorityandresponsibilityforc）所有班次的生產(chǎn)作業(yè)都安排有負(fù)責(zé)確保產(chǎn)correctiveactionarepromptlyinformedofproducts品要求符合性的負(fù)責(zé)人員或代理職責(zé)人員。6計(jì)劃6.1風(fēng)險(xiǎn)和機(jī)遇的應(yīng)對措施6.1.1和6.1.2見ISO9001:2023的要求。6.1.1計(jì)劃質(zhì)量管理體系時，組織應(yīng)考慮4.1所描述的因素和4.2所提及的要求，并確定需要應(yīng)對的風(fēng)險(xiǎn)和機(jī)遇以：a)確保質(zhì)量管理體系能夠?qū)崿F(xiàn)其預(yù)期的結(jié)果；b)加強(qiáng)有利影響；c)避免或減少不利影響；d)實(shí)現(xiàn)改進(jìn)。6.1.2組織應(yīng)計(jì)劃：a)應(yīng)對這些風(fēng)險(xiǎn)和機(jī)遇的措施；b)如何：1)在質(zhì)量管理體系過程中融入整合和實(shí)施這些措施（見4.4）；2)評價這些措施的有效性。orprocessesthatdonotconformtorequirementstoensurethatnonconformingproductisnotshippedtothecustomerandthatallpotentialnonconformingproductisidentifiedandcontained；c）productionoperationsacrossallshiftsarestaffedwithpersonnelinchargeof，ordelegatedresponsibilityfor，ensuringconformitytoproductrequirements.6Planning6.1Actionstoaddressrisksandopportunities6.1.1and6.1.2SeeISO9001:2023requirements.6.1.1Whenplanningforthequalitymanagementsystem,theorganizationshallconsidertheissuesreferredtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksandopportunitiesthatneedtobeaddressedto:a)giveassurancethatthequalitymanagementsystemcanachieveitsintendedresult(s);b)enhancedesirableeffects;c)prevent,orreduce,undesiredeffects;d)achieveimprovement.6.1.2Theorganizationshallplan:a)actionstoaddresstheserisksandopportunities;b)howto:1)integrateandimplementtheactionsintoitsqualitymanagementsystemprocesses(see4.4);2)evaluatetheeffectivenessoftheseactions.ActionstakentoaddressrisksandopportunitiesshallbeproportionatetothepotentialimpactontheconformityofNOTE1Optionstoaddressriskscanincludeavoidingrisk,takingriskinordertopursueanopportunity,eliminatingtherisksource,changingthelikelihoodorconsequences,sharingtherisk,orretainingriskbyinformeddecision.NOTE2Opportunitiescanleadtotheadoptionofnewpractices,launchingnewproducts,openingnewmarkets,addressingnewcustomers,buildingpartnerships,usingnewtechnologyandotherdesirableandviablepossibilitiestoaddresstheorganization’soritscustomers’needs.所采取的應(yīng)對風(fēng)險(xiǎn)和機(jī)遇的措施應(yīng)與其對產(chǎn)品和服productsandservices.務(wù)符合性的潛在影響相適應(yīng)。注1：應(yīng)對風(fēng)險(xiǎn)的選擇可以包括：避免風(fēng)險(xiǎn)、為獲取機(jī)遇而接受風(fēng)險(xiǎn)、消除風(fēng)險(xiǎn)源、改變風(fēng)險(xiǎn)的可能性和結(jié)果、分擔(dān)風(fēng)險(xiǎn)或經(jīng)過決策而延緩風(fēng)險(xiǎn)。注2：機(jī)遇可以帶來新實(shí)踐的采用、推出新產(chǎn)品、開啟新市場、獲得新客戶、建立合作關(guān)系、使用新技術(shù)以及能夠解決組織或其他顧客需求的其他有利可能性。Riskanalysis風(fēng)險(xiǎn)分析組織應(yīng)在風(fēng)險(xiǎn)分析中至少包含從產(chǎn)品召回、產(chǎn)品審核、使用現(xiàn)場的退貨和修理、投訴、報(bào)廢及返工的經(jīng)驗(yàn)教訓(xùn)。組織應(yīng)保存形成文件的信息，作為風(fēng)險(xiǎn)分析結(jié)果的證據(jù)。Theorganizationshallincludeinitsriskanalysis，ataminimum，lessonslearnedfromproductrecalls，productaudits，fieldreturnsandrepairs，complaints，scrap，andrework.Theorganizationshallretaindocumentedinformationasevidenceoftheresultsofriskanalysis.PreventiveactionTheorganizationshalldetermineandimplement預(yù)防措施action（s）toeliminatethecausesofpotential組織應(yīng)確定并實(shí)施措施，以消除潛在不合格的原因，nonconformitiesinordertopreventtheiroccurrence.防止不合格發(fā)生。預(yù)防措施應(yīng)與潛在問題的嚴(yán)重程Preventiveactionsshallbeappropriatetotheseverity度相適應(yīng)。ofthepotentialissues.組織應(yīng)建立一個用于減輕風(fēng)險(xiǎn)負(fù)面影響的過程，過程包括以下方面：a）確定潛在不合格及其原因；b）評價防止不合格發(fā)生的措施的需求；c）確定并實(shí)施所需的措施；d）所采取措施的成文信息；e）評審所采取的預(yù)防措施的有效性；f）利用取得的經(jīng)驗(yàn)教訓(xùn)預(yù)防類似過程中的再次發(fā)生（見ISO9001第7.1.6條）。應(yīng)急計(jì)劃組織應(yīng)：a）對保持生產(chǎn)輸出并確保顧客要求得以滿足而言必不可少的所有制造過程和基礎(chǔ)設(shè)施設(shè)備，識別并評價相關(guān)的內(nèi)部和外部風(fēng)險(xiǎn)。b）根據(jù)風(fēng)險(xiǎn)和對顧客的影響制定應(yīng)急計(jì)劃；c）準(zhǔn)備應(yīng)急計(jì)劃，以在以下任一狀況下保證供應(yīng)的持續(xù)性：關(guān)鍵設(shè)備故障（另見第.1條）；外部提供的產(chǎn)品、過程和服務(wù)中斷；常見自然災(zāi)難；火災(zāi)；公共事業(yè)中斷；信息技術(shù)系統(tǒng)受到網(wǎng)絡(luò)攻擊；勞動力短缺；或者基礎(chǔ)設(shè)施破壞；d）作為應(yīng)急計(jì)劃的補(bǔ)充，包含一個通知顧客和其他相關(guān)方的過程，告知影響顧客作業(yè)的任Theorganizationshallestablishaprocesstolessentheimpactofnegativeeffectsofriskincludingthefollowing:a）determiningpotentialnonconformitiesandtheircauses；b）evaluatingtheneedforactiontopreventoccurrenceofnonconformities；c）determiningandimplementingactionneeded；d）documentedinformationofactiontaken；e）reviewingtheeffectivenessofthepreventiveactiontaken；f）utilizinglessonslearnedtopreventrecurrenceinsimilarprocesses（seeISO9001，Section7.1.6）.ContingencyplansTheorganizationshall:a）identifyandevaluateinternalandexternalriskstoallmanufacturingprocessesandinfrastructureequipmentessentialtomaintainproductionoutputandtoensurethatcustomerrequirementsaremet；b）definecontingencyplansaccordingtoriskandimpacttothecustomer；c）preparecontingencyplansforcontinuityofsupplyintheeventofanyofthefollowing:keyequipmentfailures（alsoseeSection.1）；interruptionfromexternallyprovidedproducts，processes，andservices；recurringnaturaldisasters；fire；utilityinterruptions；cyber-attacksoninformationtechnologysystems;labourshortages；

術(shù)）和外部更改（如：ISO9001、IATF16949、核心工具及顧客特定要求）對相關(guān)要求的認(rèn)知。7.2.4其次方審核員能力組織應(yīng)證明從事其次方審核的審核員的能力。其次方審核員應(yīng)符合顧客對審核員資質(zhì)的特定要求，并證明最少具備以下核心能力，包括了解：a）汽車審核過程方法，包括基于風(fēng)險(xiǎn)的思維；b）適用的顧客特定和組織特定要求；c）ISO9001和IATF16949中適用的與審核范圍有關(guān)的要求；d）適用的待審核制造過程，包括PFMEA和控制計(jì)劃；e）與審核范圍有關(guān)的適用的核心工具要求；f）如何計(jì)劃審核、實(shí)施審核、編制審核報(bào)告并關(guān)閉審核發(fā)現(xiàn)。7.3AwarenessSeeISO9001:2023requirements.（e.g.，ISO9001，IATF16949，coretools，andcustomerspecificrequirements）.7.2.4Second-partyauditorcompetencyTheorganizationshalldemonstratethecompetenceoftheauditorsundertakingthesecond-partyaudits.Second-partyauditorsshallmeetcustomerspecificrequirementsforauditorqualificationanddemonstratetheminimumfollowingcorecompetencies，includingunderstandingof:a）theautomotiveprocessapproachtoauditing，includingriskbasedthinking；b）applicablecustomerandorganizationspecificrequirements；c）applicableISO9001andIATF16949requirementsrelatedtothescopeoftheaudit；d）applicablemanufacturingprocess（es）tobeaudited，includingPFMEAandcontrolplan；e）applicablecoretoolrequirementsrelatedtothescopeoftheaudit；f）howtoplan，conduct，prepareauditreports，andcloseoutauditfindings.7.3意識見ISO9001：2023的要求。組織應(yīng)確保在其控制下工作人員知曉：a)質(zhì)量方針；b)相關(guān)的質(zhì)量目標(biāo)；c)他們對質(zhì)量管理體系有效性的貢獻(xiàn)，包括改進(jìn)質(zhì)量績效的好處；d)不符合質(zhì)量管理體系要求的后果。Theorganizationshallensurethatpersonsdoingworkundertheorganization’scontrolareawareof:a)thequalitypolicy;b)relevantqualityobjectives;c)theircontributiontotheeffectivenessofthequalitymanagementsystem,includingthebenefitsofimprovedperformance;d)theimplicationsofnotconformingwiththequalitymanagementsystemrequirements.7.3.1Awareness-supplementalTheorganizationshallmaintaindocumentedinformationthatdemonstratesthatallemployeesare7.3.1意識——補(bǔ)充awareoftheirimpactonproductqualityandthe組織應(yīng)保持形成文件的信息，證明所有員工都認(rèn)識importanceoftheiractivitiesinachieving，到其對產(chǎn)品質(zhì)量的影響，以及他們所從事的活動在maintaining，andimprovingquality，including實(shí)現(xiàn)、保持并改進(jìn)質(zhì)量中的重要性，還包括顧客要customerrequirementsandtherisksinvolvedforthe求及不合格品帶給顧客的風(fēng)險(xiǎn)。customerwithnon-conformingproduct.7.3.2員工鼓舞和授權(quán)組織應(yīng)保持形成文件的信息，鼓舞員工實(shí)現(xiàn)質(zhì)量目標(biāo)，進(jìn)行持續(xù)改進(jìn)，并建立一個提倡創(chuàng)新的環(huán)境。該過程應(yīng)包括促進(jìn)整個組織對質(zhì)量和技術(shù)的認(rèn)知程度。7.3.2EmployeemotivationandempowermentTheorganizationshallmaintainadocumentedprocess（es）tomotivateemployeestoachievequalityobjectives，tomakecontinualimprovements，andtocreateanenvironmentthatpromotesinnovation.Theprocessshallincludethepromotionofqualityandtechnologicalawarenessthroughoutthewholeorganization.7.4CommunicationSeeISO9001:2023requirements.Theorganizationshalldeterminetheinternalandexternalcommunicationsrelevanttothequalitymanagementsystem,including:a)onwhatitwillcommunicate;b)whentocommunicate;c)withwhomtocommunicate;d)howtocommunicate;e)whocommunicates.7.4溝通見ISO9001:2023的要求。組織應(yīng)確定與質(zhì)量管理體系相關(guān)的內(nèi)部和外部溝通，包括：a)溝通什么；b)何時溝通；c)與誰溝通；d)如何溝通；7.5Documentedinformatione)由誰溝通。7.5.1GeneralSeeISO9001:2023requirements.7.5形成文件的信息7.5.1總則Theorganization’squalitymanagementsystemshallinclude:a)documentedinformationrequiredbythisInternationalStandard;b)documentedinformationdeterminedbytheorganizationasbeingnecessaryfortheeffectivenessofthequalitymanagementsystem.NOTETheextentofdocumentedinformationforaqualitymanagementsystemcandifferfromoneorganizationtoanotherdueto:—thesizeoforganizationanditstypeofactivities,processes,productsandservices;—thecomplexityofprocessesandtheirinteractions;—thecompetenceofpersons.見ISO9001:2023的要求。組織的質(zhì)量管理體系應(yīng)包括：a)本標(biāo)準(zhǔn)要求的成文信息；b)組織確定的為確保質(zhì)量管理體系有效運(yùn)行所需的成文信息。注：對于不同組織，質(zhì)量管理體系成文信息的多少與詳略程度可不同，取決于：--組織的規(guī)模，以及活動、過程、產(chǎn)品和服務(wù)的類型；--過程及其相互作用的繁雜程度；--人員的能力。QualitymanagementsystemdocumentationTheorganization’squalitymanagementsystemshall質(zhì)量管理體系文件bedocumentedandincludeaqualitymanual，whichcanbeaseriesofdocuments（electronicorhard組織的質(zhì)量管理體系應(yīng)形成文件，并包括一份質(zhì)量手冊，可由一系列（電子或硬拷貝形式的）文件構(gòu)copy）.成。質(zhì)量手冊的格式和結(jié)構(gòu)由組織自行決定，將取決于組織的規(guī)模、文化和繁雜性。假使采用一系列文件，則應(yīng)保存一份構(gòu)成組織質(zhì)量手冊文件的清單。質(zhì)量手冊應(yīng)至少包含以下內(nèi)容：a）質(zhì)量管理體系的范圍，包括任何刪減的細(xì)節(jié)和正當(dāng)?shù)睦碛?；b）為管理體系建立的形成文件的過程或?qū)ζ湟?；c）組織的過程及其順序和相互作用（輸入和輸出），包括任何外包過程控制的類型和程度；d）一個顯示組織質(zhì)量管理體系內(nèi)哪些地方滿足了顧客特定要求的文件（如：一張表格，清單或矩陣）。注：可采用一個顯示組織過程如何滿足本汽車QMS標(biāo)準(zhǔn)要求的矩陣來輔助在組織過程與本汽車QMS標(biāo)準(zhǔn)之間建立聯(lián)系。Theformatandstructureofthequalitymanualisatthediscretionoftheorganizationandwilldependontheorganization’ssize，culture，andcomplexity.Ifaseriesofdocumentsisused，thenalistshallberetainedofthedocumentsthatcomprisethequalitymanualfortheorganization.Thequalitymanualshallinclude，ataminimum，thefollowing:a）thescopeofthequalitymanagementsystem，includingdetailsofandjustificationforanyexclusions；b）documentedprocessesestablishedforthequalitymanagementsystem，orreferencetothem；c）theorganization’sprocessesandtheirsequenceandinteractions（inputsandoutputs），includingtypeandextentofcontrolofanyoutsourcedprocesses；d）adocument（forexample,atable,alist,oramatrix）indicatingwherewithintheorganization'squalitymanagementsystemtheircustomer-specificrequirementsareaddressed.NOTEAmatrixofhowtherequirementsofthisAutomotiveQMSstandardareaddressedbytheorganization'sprocessesmaybeusedtoassistwithlinkagesoftheorganization'sprocessesandthisAutomotiveQMS，7.5.2CreatingandupdatingSeeISO9001:2023requirements.Whencreatingandupdatingdocumentedinformation,theorganizationshallensureappropriate:7.5.2創(chuàng)立和更新a)identificationanddescription(e.g.atitle,date,author,or見ISO9001:2023的要求。referencenumber);在創(chuàng)立和更新成文信息時，組織應(yīng)確保適當(dāng)?shù)模篵)format(e.g.language,softwareversion,graphics)anda)標(biāo)識和說明（如：標(biāo)題、日期、、索引編號）；media(e.g.paper,electronic);b)形式（如語言、軟件版本、圖表）和載體（如紙c)reviewandapprovalforsuitabilityandadequacy.質(zhì)的、電子的）；c)評審和批準(zhǔn)，以確保適合性和充分性。7.5.3Controlofdocumentedinformation7.5.3成文信息的控制andSeeISO9001:2023requirements.Documentedinformationrequiredbythequality和見ISO9001:202