iatf16949中英文对照版 10 13新版

1、4组织的环境4 Con text of the orga ni zati on理解组织及其环境Un dersta nding the orga ni zatio n and itscon text见 ISO 9001:2015 的要求。See ISO 9001:2015 requireme nts.组织应确定与其目标和战略方向相关并影响实现其The orga ni zati onshall determ ine exter nal and internal质量管理体系预期结果的各种外部和内部因素。issues that are releva nt to its purpose and its组

2、织应对这些内部和外部因素的相关信息进行监视strategic direct ion and that affect its ability to和评审。注1:这些因素可以包括需要考虑的正面或负面的因achieve the inten ded result(s) of its quality man ageme nt system.素或条件；注2:可以通过考虑源于国际、国家、地区或本地的The orga ni zati on shall mon itor and review in formati on about these exter nal and internal issues.各种法律

3、法规、技术、竞争、市场、文化、社会和NOTE 1 Issues can in clude po sitive and n egative factors经济因素的情况，有助于理解外部环境。or con diti ons for con siderati on.注3:可以通过考虑组织的价值观、文化、知识和组NOTE 2 Un dersta nding the exter nal con text can be织绩效等相关因素状况，有助于理解内部环境。facilitated by con sideri ng issues aris ing from legal,tech no logical,co

4、mp etitive,market, cultural,social andecono mic en viro nmen ts, whether in ter nati on al, n ati on al, regi onal or local.NOTE 3 Un dersta nding the internal con text can be facilitated by con sideri ng issues related to values,理解相关方的需求和期望culture, kno wledge and p erforma nee of the orga ni zati o

5、n.见 ISO 9001:2015 的要求。由于相关方对组织持续提供满足顾客和适用的法律Un dersta nding the n eeds and exp ectatio ns of法规要求的产品和服务的能力产生影响或潜在影in terested p arties响，因此，组织应确定：See ISO 9001:2015 requireme nts.a）与质量管理体系有关的相关方；Due to their effect or poten tial effect on theb）这些相关方的要求。organization s ability to consistently provideprod

6、ucts and services that meet customer and applicable组织应对这些相关方及其要求的相关信息进行监视statutory and regulatory requireme nts, the和评审。orga ni zati on shall determ ine:a) the in terested p arties that are releva nt to thequality man ageme nt system;b) the requirements of these interested parties that arereleva nt

7、to the quality man ageme nt system.The orga ni zati on shall mon itor and review in formati onabout these in terested p arties and their releva ntrequireme nts.确定质量管理体系的范围见 ISO 9001:2015 的要求。组织应确定质量管理体系的边界和适用性，以确定 其范围。Determ ining the scope of the quality man ageme nt systemSee ISO 9001:2015 require

8、me nts.在确定质量管理体系范围时，组织应考虑:The orga ni zati on shall determ ine the boun daries anda)在中涉及的各种外部和内部因素;app licability of the quality man ageme nt systemb)在中涉及的有关相关方要求;to establish its scope.c)组织的产品与服务。Whe n determ ining this scope, the orga ni zati on shall对于本标准中适用于组织确定的质量管理体系范围 的全部要求，组织应予以实施。con sider:

9、a) the exter nal and internal issues referred to in ;组织的质量管理体系范围应作为形成文件的信息加 以保持。该范围应说明质量管理体系所覆盖的产品 和服务类型，若组织认为其管理体系范围的应用范 围不适用本标准的某些要求，应说明理由。b) the requireme nts of releva nt in terested p artiesreferred to in ;c) the p roducts and services of the orga ni zati on.那些不适用组织的质量管理体系要求，不能影响组 织确保产品和服务合格以及增

10、强顾客满意的能力或 责任，否则不能声称符合本标准的要求。The orga ni zati on shall apply all the requireme nts ofthis Intern ati onal Stan dard if they are app licablewith in the determ ined scope of its quality man ageme ntsystem.The scope of the organization s quality management system shall be available and be maintained asd

11、ocumented information.The scope shall state the types of p roducts and services covered, and p rovidejustificationfor any requirement of this InternationalStan dard that the orga ni zati on determ ines is not app licable to the scope of its quality man ageme ntsystem.Con formity to this Intern atio

12、nal Stan dard may only beclaimed if the requireme nts determ ined as n ot beingapplicabledo not affect the organization s ability orits productsresponsibilityto ensure the conformityofand services and the enhan ceme nt of customer satisfact ion.确定质量管理体系的范围补充or remote),shall支持功能，无论其在现场或外部场所（例如：设计 中心、

13、公司总部和配送中心），应包含在质量管理体 系（QMS的范围中。本汽车QMS标准唯一允许的删减是 ISO 9001第条中 的产品设计和开发要求。删减应以形成文件的信息（见ISO 9001第条）的形式进行证明和保持。Determ ining the scope of the quality man ageme nt system - suppl eme ntalSupporting functions ，whether on-site (such as design centres，corporateheadquarters ，and distribution centres be in clud

14、ed in the scope of the Quality Management System (QMS .允许的删减不包括制造过程设计。AutomotiveThe only permitted exclusion for thisQMS Sta ndard relates to the p roduct desig n and devel opment requireme nts within ISO 9001，Section . The exclusi on shall be justified and mai ntai ned as docume nted in formatio n(

15、 see ISO9001, Section ).P ermitted exclusi ons do n ot in cludemanu facturi ng p rocess desig n.顾客特定要求Customer-s pecific requireme nts应对顾客特定要求进行评价，并将其包含在组织的 质量管理体系范围内。Customer-s pecific requireme nts shall be evaluated and in cluded in the scope of the organization s quality management system.质量管理体系

16、及其过程Quality man ageme nt system and its p rocesses见 ISO 9001:2015 的要求。组织应按本标准的要求建立、实施、保持和持续改 进质量管理体系，包括质量管理体系所需的过程及 其相互作用。组织应确定质量管理体系所需的过程及其在整个ISO 9001:2015 requireme ntsThe orga ni zati onshall establish,impi eme nt, maintainand continu ally improve a quality man ageme nt system, includingthe proce

17、sses needed and their interactions,in accorda nee with the requireme nts of thisIntern ati onal Stan dard.组织中的应用，组织应:The orga ni zati on shall determ ine the pro cesses n eededa)确定这些过程所需的输入和期望的输出;for the qualitymanagementsystem and their applicationthroughout the orga ni zati on, and shall:b)确定这些过程的

18、顺序和相互作用;确定和应用所需的准则和方法（包括监视、测量 和相关的绩效指标），以确保这些过程的有效运行和 控制；c)d)确定并确保获得这些过程所需的资源;a) determ ine the inputs required and the out putsexp ected from these p rocesses;b) determ ine the seque nee and in teract ion of thesep rocesses;c) determ ine and apply the criteria and methodse)规定与这些过程相关的责任和权限;(in cludi

19、 ng mon itori ng, measureme nts and related应按照的要求确定风险和机遇;f)评价这些过程，实施所需的更改，以确保这些过g）程实现预期的结果;d) determ ine the resources n eeded for these p rocessesand en sure their availability;h）改进过程和质量管理体系。e) assig n the respon sibilities and authorities forthese pro cesses;f) address the risks and opportunitiesa

20、s determined inaccorda nee with the requireme nts of ;g) evaluate these p rocesses and imp leme nt any cha ngesn eeded to en sure that these p rocesses achieve theirinten ded results;h) imp rove the p rocesses and the quality man ageme ntsystem.1. 1 Con forma nee of p roducts and p rocesses产品和过程的符合性

21、组织应确保所有的产品和过程，包括服务件及外包 的产品和过程，符合一切适用的顾客和法律法规要 求（见条）。The orga ni zati on shall en sure con forma nee of all products and processes， including service parts and those that are outsourced，to all applicable customer，statutory ，and regulatory requirements (see Sect ion).Product safety产品安全组织应有形成文件的过程，用于与产

22、品安全有关的The orga ni zati on shall have docume nted p rocesses for the man ageme nt of p roduct-safety related products and manufacturing processes，whichshall in elude but not be limited to thePerformanee indicators)needed to ensure the effective op erati on and con trol of these pro cesses;following ,

23、 where applicable:产品和制造过程管理；形成文件的过程包括但不限 于（在适用情况下）：a)组织应对产品安全法律法规要求的识别;b)向顾客通知a）项中的要求;a ) identification by the organization of statutory and regulatory p roduct-safety requirements ;c）设计FMEA勺特殊批准;b ) customer notificationof requirements initem a )；d)产品安全相关特性的识别;c ) special approvals for design FMEA

24、e)产品及制造时安全相关特性的识别和控制;控制计划和过程 FMEA勺特殊批准;d ) identificationof product safety-relatedcharacteristics ；g)反应计划（见第条）；h)包括最高管理者在内的，明确的职责，升级 过程和信息流的定义，以及顾客通知；e ) ide ntificatio n and con trols of safety-related characteristics of product and at the point ofk)h ) defined responsibilities, definition ofescala

25、ti on p rocess and flow of in formati on,including top management , and customer no tificati on；j ) changes of product or process shall be approved prior to impiementation, includingevaluatio n of poten tial effects on p roduct safety from process and product changes (see ISO 9001, Section )；组织或顾客为与

26、产品安全有关的产品和相 关制造过程中涉及的人员确定的培训；产品或过程的更改在实施之前应获得批准, 包括对过程和产品更改带给产品安全的潜 在影响进行评价（见ISO 9001第条）;整个供应链中关于产品安全的要求转移, 括顾客指定的货源（见第条）；整个供应链中按制造批次（至少）的产品可 追溯性（见第条）；为新产品导入的经验教训。注：顾客或者组织内部程序可要求与安全相关的要 求或者文件的特殊批准。manufacture ;f ) special approval of control plans and p rocess FMEAs；g ) react ion plans (see Section

27、)；i ) training identified by the organization or customer for personnel invo Ived in p roduct 画 safety related products and associated manu facturi ng p rocesses ;k ) tran sfer of requireme nts with regard to p roduct safety throughout the supply cha in in clud ing customer-desig nated sources(seeSe

28、ctio n )；l ) product traceability by manufactured lot (at a minimum throughout the supply chain (seeSectio n )；m )lessons learned for new product in troducti on.NOTE: Sp ecial appro val of safety related requirements or documents maybe required by the customer or the organization s internal p rocess

29、es.ISO 9001:2015 requireme nts.To the exte nt n ecessary, the orga ni zati on shall:a) maintain docume nted in formatio n to support the op erati on of its pro cesses;b) reta in docume nted in formatio n to have con fide nee that the p rocesses are being carried out as planned.5 Leadersh ip在必要的程度上，组

30、织应:Leadershi p and commitme nt见 ISO 9001:2015 的要求。Generala）保持形成文件的信息以支持过程运行;See ISO 9001:2015 requireme nts.b）保留确认其过程是按策划进行的形成文件的信 息。Gen eral 总则Top man ageme nt shall dem on strate leadersh ip andcommitme nt with respect to the quality man ageme ntsystem by:a) tak ing acco un tability for the effect

31、 iven ess of thequality man ageme nt system;b) en suri ng that the quality p olicy and qualityobjectives are established for the quality man ageme ntsystem and are comp atible with the con text and strategic5领导作用directi on of the orga ni zati on;领导作用与承诺c) en suri ng the in tegrati on of the quality

32、man ageme ntsystem requireme nts into the orga ni zati ons bus in ess总则p rocesses;见 ISO 9001:2015 的要求。d) pro moti ng the use of the pro cess app roach andrisk-based thinking;最高管理者应证实其对质量管理体系的领导作用和 承诺，通过：e) en suri ng that the resources n eeded for the qualityman ageme nt system are available;a）对质量管理

33、体系的有效性承担责任;f) com mun icati ng the imp orta nee of effective qualityb）确保制定质量管理体系的质量方针和质量目标, 并与组织环境和战略方向保持一致；management and of conforming to the quality managementsystem requireme nts;c)确保将质量管理体系要求融入组织的业务过程;g) ensuring that the qualitymanagementsystem achievesd)促进使用过程方法和基于风险的思维;its inten ded results;

34、e)确保获得质量管理体系所需的资源;h) en gagi ng, direct ing and supporting persons tocon tribute to the effective ness of the quality沟通有效的质量管理体系和符合质量管理体系f）要求的重要性;man ageme nt system;g）确保实现质量管理体系的预期结果;i) pro moti ng impro veme nt;h）促使、指导和支持员工努力提高质量管理体系的 有效性；j)supporting other releva nt man ageme nt roles todem on st

35、rate their leadershi p as it app lies to theirareas of res pon sibility.i）推动改进;NOTE Refere nee to“ bus in ess ” in this Intern ati onalj）支持其他管理者履行其相关领域的职责。Stan dard can be in ter pr eted broadly to mea n those注：本标准中的“业务”一词可大致理解为涉及组 织存在目的的核心价值活动，组织可以是公有的、 私有的、盈利或非盈利的。activities that are core to the p

36、urpo ses of theorganization s existenee, whether the organization isp ublic, p rivate, for pr ofit or not for p rofit.Corporate respon sibilityThe orga ni zati on shall defi ne and impi eme nt corporate responsibility policies ， including at a minimum an anti-bribery policy， an empioyeecode of con d

37、uct，and an ethics escalati on p olicy (“whistle-blowing policy”).Process effective ness and efficie ncyTop man ageme nt shall review the p roduct realizatio n p rocesses and support p rocesses to evaluate and improve their effective ness and efficie ncy. The results of the p rocess review activities

38、 shall be in cluded as input to the management review ( see Section .).P rocess owners公司责任组织应明确并实施公司责任方针，至少包括反贿赂 方针、员工行为准则以及道德准则升级政策（“举 报政策”）。Top managementshall identifyprocess owners whoare responsible for managing the organizations p rocesses and related out pu ts. Process owners shall understand

39、 their roles and be competent to perform those roles ( see ISO 9001，Section ).Customer focusSee ISO 9001:2015 requireme nts.过程有效性和效率最高管理者应评审产品实现过程和支持过程，以评 价并改进过程有效性和效率。过程评审活动的结果 应作为管理评审的输入（见第条）。Top man ageme nt shall dem on strate leadersh ip andcommitment with respect to customer focus by ensuringt

40、hat:a) customer and app licable statutory and regulatory requireme nts are determ in ed, un derstood andcon siste ntly met;b) the risks and opportun ities that can affectcon formity of p roducts and services and theability toaddressed;enhance customer satisfacti on are determ ined and过程拥有者最高管理者应确定过程

41、拥有者，由其负责组织的各 过程和相关输出的管理。过程拥有者应了解他们的 角色，并且具备胜任其角色的能力（见 ISO 9001 条）.c) the focus on enhancing customer satisfact ion is mai ntai ned.P olicyEstablish ing the qualify p olicy以顾客为关注焦点See ISO 9001:2015 requireme nts.见 ISO 9001:2015 的要求。Top management shall establish,impiement and maintaina quality p olic

42、y that:最高管理者应通过以下方面，证实其对以顾客为关注焦点的领导作用和承诺：a) is approp riate to the purpose and con text of the orga ni zati on and supp orts its strategic directi on;a）确定、理解和持续满足顾客要求以及适用的法律和法规要求；b) provides a framework for settingquality objectives;b）确定和应对能够影响产品和服务符合性以及增c) in cludes a commitme nt to satisfy app lic

43、able强顾客满意能力的风险与机遇；requireme nts;C）始终致力于增强顾客满意。d) includes a commitment to continual improvement of the quality man ageme nt system.Communi cati ng the quality p olicy方针See ISO 9001:2015 requireme nts.The quality p olicy shall:建立质里方针a) be available and be maintained as docume nted见 ISO 9001:2015 的要求。

44、in formati on;最高管理者应制定、实施和保持质量方针，方针应：b) be com muni cated, un derstood and app lied with in the orga ni zati on;a）与组织的宗旨和环境相适应，并支持其战略方向；c) be available to releva nt in terested p arties, as approp riate.b）提供制定质量目标的框架C）包括对满足适用要求的承诺；d）包括对持续改进质量管理体系的承诺。Organizational roles，responsibilities andauthoriti

45、esSee ISO 9001:2015 requireme nts.Top man ageme nt shall en sure that the respon sibilities and authorities for releva nt roles are assig ned, com muni cated and un derstood with in the orga ni zati on.Top man ageme nt shall assig n the respon sibility and沟通质量方针authority for:见 ISO 9001:2015 的要求。a) e

46、n suri ng that the qualityman ageme ntsystem con formsto the requirementsof this InternationalStandard;质量方针应：b) en suri ng that the p rocesses are deliveri ng theira）作为形成文件的信息，可获得并保持；inten ded out pu ts;b）在组织内得到沟通、理解和应用C）适宜时，可向有关相关方提供。c) reporting on the p erforma nee of the qualityman ageme nt syst

47、em and on opportun ities for impro veme nt (see , in p articular to top man ageme nt;组织的作用、职责和权限见 ISO 9001:2015 的要求。最高管理者应确保相关角色的职责和权限在整个组 织内得到分派、沟通和理解。最高管理者应分派职责和权限，以:a)确保质量管理体系符合本标准的要求;b)确保各过程获得其预期的输出;报告质量管理体系的绩效和改进机会，特别向最 高管理者；C）d）确保在整个组织推动以顾客为关注焦点;e）确保在策划和实施质量管理体系的更改时保持 其完整性。d) ensuring the prom

48、otion of customer focus throughout the orga ni zati on;e) ensuring that the integrityof the quality managementsystem is mai ntai ned whe n cha nges to the quality man ageme nt system are planned and impi eme nted.Organizational roles，responsibilities，andauthorities - supp leme ntalTop man ageme nt s

49、hall assig n personnel with the respon sibility and authority to en sure that customer requirements are met. These assignments shall be docume nted. This in cludes but is not limited to the select ion of sp ecial characteristics ， setting quality objectives and related training，corrective and Preven

50、tiveactions ,product design and development ,capacity analysis ，logistics information， customerscorecards，and customer portals.Respon sibility and authority for p roduct requireme nts and corrective acti onsTop man ageme nt shall en sure that:a )personnel responsible for conformity toproduct require

51、ments have the authority to stop shipment and stop production to correct quality problems ；NOTE Due to the p rocess desig n in some industries ，it might not always be possible to stop production immediately. In this case，the组织的作用、职责和权限补充affected batch must be contained and shipment to the customer p

52、 reve nted.最高管理者应向人员指派职责和权限，以确保顾客 要求得到满足。这些指派应形成文件。这包括但不 限于：特殊特性的选择，质量目标和相关培训的设b )personnel with authority and respon sibility for corrective acti on are置，纠正和预防措施，产品设计和开发，产能分析, 物流信息，顾客计分卡以及顾客门户。promp tly in formed of p roducts or p rocesses do not conform to requireme nts to en sure that nonconformi

53、ng p roduct is not shipped to the customer and that all poten tial nonconforming p roduct is ide ntified and contained；thatc )p roducti on op eratio ns across all shifts are staffed with personnel in charge of，ordelegated responsibility for ，ensuring con formity to p roduct requireme nts.产品要求和纠正措施的职

54、责和权限6 Planning最高管理者应确保:Actions to address risks and opportun itiesa)负责产品要求符合性的人员有权停止发运或生产以纠正质量问题;注：由于一些行业中的过程设计，并非总是 能立即停止生产。在这种情况下，必须对受 影响批次进行控制，以防将其发运给顾客。b)拥有纠正措施权限和职责的人员能够及时获知与要求不符的产品或过程， 以确保避免 将不合格品发运给顾客，并确保所有潜在不 合格品得到识别与控制；and ISO 9001:2015 requireme nts.When planning for the quality man ageme

55、nt system, theorga ni zati on shall con sider the issues referred to inand the requirementsreferred to in and determinerisks and opportun ities that n eed to be addressed to:a) give assuranee that the qualitymanagementsystemachieve its inten ded result(s);b) enhance desirable effects;thecanc) preven

56、t, or reduce, un desired effects;c)所有班次的生产作业都安排有负责确保产品要求符合性的负责人员或代理职责人员。d) achieve imp roveme nt.The orga ni zati on shall plan:a) actions to address these risks and opportun ities;b) how to:1) in tegrate and imp leme nt the acti ons into its quality man ageme nt system p rocesses (see ;be2) evaluate the effect iven ess of these actions.Actions taken to address ris