IATF16949-中英文对照版2017-10-13NEW

1、4组织的环境4.1理解组织及其环境见 ISO 9001:2022 的要求。组织应确定与其目标和战略方向相关并影响实现其质 量管理体系预期结果的各种外部和内部因素。组织应对这些内部和外部因素的相关信息进行监视和 评审。注1：这些因素可以包括需要考虑的正面或负面的因素或条件；注2:可以通过考虑源于国际、国家、地区或本地的各 种法律法规、技术、竞争、市场、文化、社会和经济因 素的情况，有助于理解外部环境。注3：可以通过考虑组织的价值观、文化、知识和组织 绩效等相关因素状况，有助于理解内部环境。4.2理解相关方的需求和期望见 ISO 9001:2022 的要求。由于相关方对组织持续提供满足顾客和适用的

2、法律法 规要求的产品和效劳的能力产生影响或潜在影响，因 此，组织应确定：a与质量管理体系有关的相关方；b这些相关方的要求。组织应对这些相关方及其要求的相关信息进行监视和 评审。4.3确定质量管理体系的范围见 ISO 9001:2022 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。在确疋质量管理体系范围时，组织应考虑：4 Con text of the orga ni zati on4.1 Un dersta nding the orga ni zati on and its con text See ISO 9001:2022 requireme nts.The orga n

3、i zati on shall determ ine exter nal and internal issues that are releva nt to its purpose and its strategic directi on and that affect its ability to achieve the inten ded result(s) of its quality man ageme nt system.The orga ni zati on shall mon itor and review in formati on about these exter nal

4、and in ter nal issues.NOTE 1 Issues can include positive and negative factors or con diti ons for con siderati on.NOTE 2 Un dersta nding the exter nal con text can be facilitated by con sideri ng issues aris ing from legal, tech no logical, competitive, market, cultural, social and econo mic en viro

5、 nmen ts, whether in ter nati on al, n ati on al, regi onal or local.NOTE 3 Un dersta nding the in ternal con text can be facilitated by con sider ing issues related to values, culture, kno wledge and performa nee of the orga ni zati on.4.2 Un dersta nding the n eeds and expectati ons of in terested

6、 partiesSee ISO 9001:2022 requireme nts.Due to their effect or pote ntial effect on the orga ni zati on ability to con siste ntly provide products and services that meet customer and applicable statutory and regulatory requireme nts, the orga ni zati on shall determ ine:a) the in terested parties th

7、at are releva nt to the quality man ageme nt system;b) the requireme nts of these in terested parties that are releva nt to the quality management system.The orga ni zati on shall mon itor and review in formati on about these in terested parties and their releva nt requireme nts.4.3 Determi ning the

8、 scope of the quality man ageme nt systemSee ISO 9001:2022 requireme nts.The orga ni zati on shall determ ine the bou ndaries and applicability of the quality management system to establish its scope.Whe n determ ining this scope, the orga ni zati on shall con sider:a) the exter nal and internal iss

9、ues referred to in 4.1;a在中涉及的各种外部和内部因素；b在中涉及的有关相关方要求；C组织的产品与效劳。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。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效劳 类型，假设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。那些不适用组织的质量管理体系要求，不能影响组织确 保产品和效劳合格以及增强顾客满意的能力或责任， 否 那么不能声称符合本标准的要求。确定质量管理体系的范围-补充支持功能，无论其在现场或外部场所例如：设计中心、 公司总部和配

10、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8.3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7.5条的形式进行证明和保持。允许的删减不包括制造过程设计。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。b) the requireme nts of releva nt in terested parties referred to in4.2;c) the products and services of the orga ni zati on.The orga ni zati on shall

11、 apply all the requireme nts of this In ter nati onal Stan dard if they are applicable within the determ ined scope of its quality man ageme nt system.The scope of the organization s quality management sysshall be available and be maintained as docume ntedin formati on. The scope shall state the typ

12、es of products and services covered, and provide justification for any requirement of this In ter nati onal Stan dard that the orga ni zati on determ ines is not applicable to the scope of its quality man ageme nt system. Conformity to this International Standard may only be claimed if the requireme

13、 nts determ ined as not being applicable do not affect the organization s ability or responsibility to ensure tcon formity of its products and services and the enhan ceme nt of customer satisfacti on.4.3.1 Determi ning the scope of the quality man ageme nt system - suppleme ntalSupporting functions,

14、 whether on-site or remotesuch as design centres corporate headquarters，and distribution centres，shall be included in the scope of the Quality Management System QMS.The only permitted exclusion for this Automotive QMS Stan dard relates to the product desig n and development requirements within ISO 9

15、001，Section 8.3. The exclusion shall be justified and maintained as documented information see ISO 9001 Section 7.5.Permitted exclusi ons do not in clude manu facturi ng process desig n.4.3.2 Customer-specific requireme nts Customer-specific requireme nts shall be evaluated and included in the scope

16、 of the organizations quality man ageme nt system.4.4 Quality man ageme nt system and its processesSee ISO 9001:2022 requireme nts4.4.1 The orga ni zati on shall establish, impleme nt, maintain and4.4质量管理体系及其过程见 ISO 9001:2022 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

17、在整个组织中的应用，组织应：a确定这些过程所需的输入和期望的输出；b确定这些过程的顺序和相互作用；C确定和应用所需的准那么和方法包括监视、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；d确定并确保获得这些过程所需的资源；e规定与这些过程相关的责任和权限；f应按照的要求确定风险和机遇；g评价这些过程，实施所需的更改，以确保这些过程 实现预期的结果；h改进过程和质量官理体系。产品和过程的符合性组织应确保所有的产品和过程，包括效劳件及外包的产 品和过程，符合一切适用的顾客和法律法规要求见8.4.2.2 条。产品平安组织应有形成文件的过程，用于与产品平安有关的产品和制造过程管理；形成文件的过

18、程包括但不限于在适用情况下：a组织应对产品平安法律法规要求的识别；b向顾客通知a项中的要求；c设计FMEA的特殊批准；d产品平安相关特性的识别；contin ually improve a quality man ageme nt system, in clud ing the processes n eeded and their in teracti ons, in accorda nee with the requireme nts of this In ter nati onal Stan dard.The orga ni zati on shall determ ine the pr

19、ocesses n eeded for the quality man ageme nt system and their applicati on throughout the orga ni zati on, and shall:a) determ ine the in puts required and the outputs expected from these processes;b) determ ine the seque nee and in teracti on of these processes;c) determ ine and apply the criteria

20、and methods (in clud ing mon itori ng, measureme nts and related performa nee in dicators) n eeded to en sure the effective operati on and con trol of these processes;d) determ ine the resources n eeded for these processes anden sure their availability;e) assign the responsibilities and authorities

21、for these processes;f) address the risks and opportu nities as determ ined in accorda nee with the requireme nts of 6.1;g) evaluate these processes and impleme nt any cha nges n eeded to en sure that these processes achieve their inten ded results;h) improve the processes and the quality man ageme n

22、t system.4.4. 1. 1 Con forma nee of products and processes 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 Section 8.422.4.4.1.2 Product safetyT

23、he orga ni zati on shall have docume nted processes for the man ageme nt of product-safety related products and manu facturi ng processes which shall in elude but not be limited to the following , where applicable: a identification by the organization of statutory and regulatory product-safety requi

24、reme nts ； b customer notification of requirements in item a；cspecial approvals for design FMEA d identification of product safety-related characteristics；e identification and controls of safety-related characteristics of product and at the point ofe产品及制造时平安相关特性的识别和控制；f控制方案和过程 FMEA的特殊批准；g反响方案见第 条；h

25、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；i组织或顾客为与产品平安有关的产品和相关制造过程中涉及的人员确定的培训；j 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平安的潜在影响进行评价见 ISO 9001第836条；k 整个供应链中关于产品平安的要求转移，包括 顾客指定的货源见第 843.1条；l 整个供应链中按制造批次至少的产品可追 溯性见第8.521条；m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平安相关的要求或 者文件的特殊批准。manu facture；fspecial approval of control pla

26、ns and process FMEAsgreaction planssee Section 9.1.1.U ；hdefined responsibilities，definition of escalation process and flow of information， including top management， and customer notification ；i training identified by the organization or customer for personnel invoIved in product 画 safety related pr

27、oducts and associated manu facturi ng processesjchanges of product or process shall be approved prior to implementation， including evaluation of pote ntial effects on product safety from process and product changes see ISO 9001 Section 836；ktransfer of requirements with regard to product safety thro

28、ughout the supply chain，including customer-designated sources see Section 843.1 ；Iproduct traceability by manufactured lot at a minimumthroughout the supply chain see Section ；mlessons learned for new product introduction.NOTE: Special approval of safety related requireme nts or docume nts may be re

29、quired by the customer or the orga ni zati on internal processes.See ISO 9001:2022 requirements.4.4.2 To the exte nt n ecessary, the orga ni zati on shall:a) mai ntain docume nted in formatio n to support the operati on of its processes;b) reta in docume nted in formati on to have con fide nee that

30、the processes are being carried out as pla nn ed.在必要的程度上，组织应：见 ISO 9001:2022 的要求。a保持形成文件的信息以支持过程运行；b保存确认其过程是按筹划进行的形成文件的信息。5 Leadership5.1 Leadership and commitme nt5.1.1 GeneralSee_ISO_9001:2022_requireme nts.学习文档仅供参考5领导作用领导作用与承诺总那么见 ISO 9001:2022 的要求。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：a对质量管理体系的有效性承当责任；b确保

31、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；c确保将质量管理体系要求融入组织的业务过程；d促进使用过程方法和基于风险的思维；e确保获得质量管理体系所需的资源；f沟通有效的质量管理体系和符合质量管理体系要求 的重要性；g确保实现质量管理体系的预期结果；h促使、指导和支持职工努力提高质量管理体系的有 效性；i推动改进；j支持其他管理者履行其相关领域的职责。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。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、职工行为准那么以及道德准那么升级政策举报政c

32、anhe5.1.1 General 总那么Top man ageme nt shall dem on strate leadership and commitme nt with respect to the quality man ageme nt system by:a) tak ing accou ntability for the effective ness of the quality man ageme nt system;b) en suri ng that the quality policy and quality objectives are established fo

33、r the quality man ageme nt system and are compatible with the con text and strategic directi on of the orga ni zati on;c) en sur ing the in tegrati on of the quality man ageme nt systemrequireme nts into the orga ni zati onbus in essprocesses;d) promoting the use of the process approach and risk-bas

34、ed thi nki ng;e) en suri ng that the resources n eeded for the quality man ageme nt system are available;f) commu ni cat ing the importa nee of effective qualityman ageme nt and of con formi ng to the quality man ageme nt system requireme nts;g) ensuring that the quality management system achieves i

35、ts inten ded results;h) en gag ing, direct ing and support ing pers ons to con tribute to the effective ness of the qualityman ageme nt system;i) promoti ng improveme nt;j) support ing other releva nt man ageme nt roles to dem on strate their leadership as it applies to their areas of resp on sibili

36、ty.NOTE Refere nee to “ bus in ess in this Intern ati onal Standar be interpreted broadly to mean those activities that are core to the purposes of the organization s existenee, whether torganization is public, private, for profit or not for profit.5.1.1.1 Corporate resp on sibilityThe organization

37、shall define and implement corporate responsibility policies, including at a minimum an an ti-bribery policy, an employee code of con duct, and an ethics escalation policy“whistle-blowing policy .5.1.1.2 Process effective ness and efficie ncyTop man ageme nt shall review the product realizati on pro

38、cesses and support processes to evaluate and improve their effective ness and efficie ncy. The results of the process review activities shall be in cluded as in put to the man ageme nt review see Section 932.1.策。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9.321条。过程拥有者最高管理者应确定过程拥

39、有者，由其负责组织的各过程和相关输岀的管理。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第7.2条.见 ISO 9001:2022 的要求。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确定和应对能够影响产品和效劳符合性以及增强顾 客满意能力的风险与机遇；C始终致力于增强顾客满意。方针建立质量方针见 ISO 9001:2022 的要求。最高管理者应制定、实施和保持质量方针，方针应：a与组织的宗旨和环境相适应，并支持其战略方向；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

40、持续改进质量管理体系的承诺。5.1.1.3 Process ownersTop man ageme nt shall ide ntify process owners who are resp on sible for managing the orga ni zati ons processes and related outputs. Process owners shall un dersta nd their roles and be compete nt to perform those rolessee ISO 9001 Section 7.2.5.1.2 Customer foc

41、usSee ISO 9001:2022 requirements.Top man ageme nt shall dem on strate leadership andcommitme nt with respect to customer focus by en sur ing that:a) customer and applicable statutory and regulatory requireme nts are determ in ed, un derstood and con siste ntly met;b) the risks and opportu nities tha

42、t can affect con formity of products and services and the ability to enhance customer satisfacti on are determ ined and addressed;c) the focus on enhancing customer satisfacti on is maintain ed.5.2 Policy5.2.1 Establish ing the qualify policySee ISO 9001:2022 requireme nts.Top man ageme nt shall est

43、ablish, impleme nt and maintain a quality policy that:a) is appropriate to the purpose and con text of the orga ni zati on and supports its strategic directi on;b) provides a framework for sett ing quality objectives;c) in cludes a commitme nt to satisfy applicable requireme nts;d) in cludes a commi

44、tme nt to contin ual improveme nt of the quality man ageme nt system.5.2.2 Communi cat ing the quality policySee ISO 9001:2022 requireme nts.The quality policy shall:a) be available and be maintained as docume nted in formati on;b) be commu ni cated, un derstood and applied withi n the orga ni zati

45、on;c) be available to releva nt in terested parties, as appropriate.5.3 Organizational roles, responsibilities and authoritiesSee ISO 9001:2022 requireme nts.Top man ageme nt shall en sure that the resp on sibilities and authorities for releva nt roles are assig ned, commu ni cated and沟通质量方针见 ISO 90

46、01:2022 的要求。质量方针应：a作为形成文件的信息，可获得并保持；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。5.3组织的作用、职责和权限见 ISO 9001:2022 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；c报告质量管理体系的绩效和改进时机，特别向最咼管理者；d确保在整个组织推动以顾客为关注焦点；e确保在筹划和实施质量管理体系的更改时保持其完 整性。组织的作用、职责和权限-补充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

47、。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。un derstood with in the orga ni zati on.Top management shall assign the responsibility and authority for:a) en suri ng that the quality man ageme nt system con forms to the requireme nts of this Intern ati onal Stan dard

48、;b) ensuring that the processes are delivering their intended outputs;c) report ing on the performa nee of the quality man ageme nt system and on opportunities for improvement (see 10.1), in particular to top man ageme nt;d) ensuring the promotion of customer focus throughout the orga ni zati on;e)

49、ensuring that the integrity of the quality management system is maintained when changes to the quality management system are pla nned and impleme nted.5.3.1 Organizational roles， responsibilities，and authorities - suppleme ntalTop man ageme nt shall assig n pers onnel with the resp on sibility and a

50、uthority to en sure that customer requireme nts are met. These assig nments shall be documented. This includes but is not limited to the selection of special characteristics setting quality objectives and related training，corrective and Preventive actions, product design and development， capacity an

51、alysis logistics information，customer scorecards and customer portals.5.3.2 Resp on sibility and authority for product requireme nts and corrective acti onsTop man ageme nt shall en sure that:apersonnel responsible for conformity to product requireme nts have the authority to stop shipme nt and stop

52、 product ion to correct quality problems ； NOTE Due to the process design in some industries it might not always be possible to stop product ion immediately. In this case, the affected batch must be contained and shipme nt to the customer preve nted.bpersonnel with authority and responsibility for c

53、orrective action are promptly in formed of products or processes that do not conform to requireme nts to en sure that nonconforming product is not shipped to the customer and that all potential nonconforming产品要求和纠正措施的职责和权限最高管理者应确保：a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

54、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，以确保防止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；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。6筹划6.1风险和机遇的应对措施见 ISO 9001:2022 的要求。筹划质量管理体系时，组织应考虑所描述的因素 和所提及的要求，并确定需要应对的风险和机遇以：a确保质量管理体系能够实现其预期的结果；b增强有利影响；c防止或减少不利影响；d实现改进。组织应筹划：a应对这些风险和机遇的措施；b如何：1在质量管理体系过程中融入整合和实施这

55、些措 施见；2评价这些措施的有效性。所采取的应对风险和机遇的措施应与其对产品和效劳 符合性的潜在影响相适应。product is identified and contained ；cproduct ion operati ons across all shifts are staffed with personnel in charge of，or delegated responsibility for， ensuring conformity to product requireme nts.6 Pla nning6.1 Acti ons to address risks and opp

56、ort un itiesSee ISO 9001:2022 requireme nts.6.1.1 When pla nning for the quality man ageme nt system, the orga ni zati on shall con sider the issues referred to in 4.1 and the requireme nts referred to in 4.2 and determ ine the risks and opportu nities that n eed to be addressed to:a) give assura ne

57、e that the quality man ageme nt system can achieve its inten ded result(s);b) enhance desirable effects;c) preve nt, or reduce, un desired effects;d) achieve improveme nt.6.1.2 The orga ni zati on shall pla n:a) actions to address these risks and opportunities;b) how to:1) in tegrate and impleme nt the acti ons into its qualityman ageme nt system processes (see 4.4);2) evaluate t