IATF16949中英文对照版2017-10-13新版

1、4组织的环境4.1理解组织及其环境见 ISO 9001:2015 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 9001:2015 的要求。由于相关方对组织持续提供满足顾客和适用

2、的法律 法规要求的产品和服务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 9001:2015 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。在确疋质量管理体系范围时，组织应考虑：a）在4.1中涉及的各种外部和内部因素；4Con text of the orga ni zati on4.1 Un dersta nding the orga ni zati on and its con text See ISO 9001:2015 re

3、quirements.The orga ni 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 a

4、bout these exter nal and internal 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 an

5、d econo 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 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

6、 ons of in terested partiesSee ISO 9001:2015 requireme nts.Due to their effect or pote ntial effect on the orga ni zatio n 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

7、terested parties that 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 man ageme nt 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

8、.4.3 Determi ning the scope of the quality man ageme nt systemSee ISO 9001:2015 requireme nts.The organization shall determine the boundaries and applicability of the quality man ageme nt system to establish its scope.When determ ining this scope, the orga ni zati on shall con sider:b）在4.2中涉及的有关相关方要

9、求；c）组织的产品与服务。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。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。4.3.1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 9

10、001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。4.3.2顾客特定要求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。4.4质量管理体系及其过程a) the exter nal and internal issues referred to in 4.1;b) the requireme nts of releva nt in terested parties referred to in 4.2;c) the products and services of the or

11、ga ni zati on.The orga ni zati on shall apply all the requireme nts of this International Standard if they are applicable within the determ ined scope of its quality man ageme nt system.The scope of the organization s quality managemenishall be available and be maintained as docume ntedin formati on

12、. The scope shall state the types of products and services covered, and provide justificati on for any requireme nt of this Intern ati onal Stan dard that the orga ni zati on determ ines is not applicable to the scope of its quality man ageme nt system.Con formity to this Intern atio nal Stan dard m

13、ay only be claimed if the requirements determined as not being applicable do not affect the organization s abresp on sibility to en sure the con formity of its products and services and the enhan ceme nt of customer satisfact ion.4.3.1 Determi ning the scope of the quality man ageme nt system - supp

14、leme ntalSupporting functions, whether on-site or remote(such as design centres corporate headquarters，and distribution centres)，shall be included in the scope of the Quality Management System( QMS).The only permitted exclusi on for this Automotive QMS Stan dard relates to the product desig n and de

15、velopment requirements within ISO 9001，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 ntsCustomer-specific requireme nts shall be

16、 evaluated and included in the scope of the organizationquality sman ageme nt system.4.4 Quality man ageme nt system and its processes4.4.1See ISO 9001:2015 requireme ntssystemlity or4.4.1 The orga ni zatio n shall establish, impleme nt, maintain441见 ISO 9001:2015 的要求。4.4.1组织应按本标准的要求建立、实施、保持和持 续改进质量

17、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 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；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6.1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）改进过程和质量管理体系。4.4.1.1产品和过程的符合性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

18、适用的顾客和法律法规要 求（见 8.4.2.2 条）。4.4.1.2产品安全组织应有形成文件的过程，用于与产品安全有关的 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；c）设计FMEA的特殊批准；d）产品安全相关特性的识别；e）产品及制造时安全相关特性的识别和控制；f）控制计划和过程 FMEA的特殊批准；g）反应计划（见第9.1.1.1条）；and continu ally improve a quality man ageme nt system, in clud ing the processes n

19、 eeded and their in teracti ons, in accorda nee with the requireme nts of this Intern ati onal Stan dard.The orga ni zati on shall determ ine the processes 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

20、and the outputs expected from these processes;b) determ ine the seque nee and in teract ion of these processes;c) determ ine and apply the criteria and methods (in cludi ng mon itori ng, measureme nts and related performa neein dicators) n eeded to en sure the effective operati on and con trol of th

21、ese processes;d) determ ine the resources n eeded for these processes and en sure their availability;e) assign the responsibilities and authorities for these processes;f) address the risks and opport un ities as determ ined in accorda nee with the requireme nts of 6.1;g) evaluate these processes and

22、 impleme nt any cha ngesn eeded to en sure that these processes achieve their inten ded results;h) improve the processes and the quality man ageme nt system.4.4. 1. 1Con forma nee of products and processesThe orga ni zati on shall en sure con forma nee of all products and processes including service

23、 parts and those that are outsourced，to all applicable customer， statutory， and regulatory requirements( see Section 8.4.2.2).4.4.1.2 Product safetyThe 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 i

24、n elude but not be limited to the following，where applicable:a) identification by the organization of statutory and regulatory product-safety requireme nts；b) customer notification of requirements in itema)；c) special approvals for design FMEAd) identification of product safety-related characteristi

25、cs：h）包括最咼管理者在内的，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；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安全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安全的要求转移，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安全相关的要 求或者文件的特殊批准。4.4.2在必要的程度上，组织应：见 ISO 9001:201

26、5 的要求。a）保持形成文件的信息以支持过程运行；b）保留确认其过程是按策划进行的形成文件的信 息。e) identification and controls of safety-related characteristics of product and at the point of manu facture ；f) special approval of control plans and process FMEAsg) react ion pla ns( see Secti on 9.1.1.1 ；h) defined responsibilities，definition of e

27、scalation process and flow of information， including topmanagement， and customer notification ；i) training identified by the organization or customer for personnel invoIved in product 画 safety related products and associated manu facturi ng processesj) changes of product or process shall be approved

28、 prior to implementation， including evaluation ofpote ntial effects on product safety from process and product changes( see ISO 9001 Section 8.3.6);k) transfer of requirements with regard to product safety throughout the supply chain，including customer-desig nated sources (see Sectio n 8.4.3.1 ；l) p

29、roduct traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8.5.2.1)；m) lessons learned for new product introduction.NOTE: Special approval of safety related requireme nts or documents may be required by the customer or the organization s internal processes.4.4.2S

30、ee ISO 9001:2015 requireme nts.4.4.2 To the exte nt n ecessary, the orga ni zati on shall:a) maintain documented information to support the operation of its processes;b) retain docume nted in formatio n to have con fide nee that the processes are being carried out as pla nn ed.5 Leadership5.1 Leader

31、ship and commitme nt5.1.1 General5领导作用5.1领导作用与承诺5.1.1总贝U见 ISO 9001:2015 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担责任；b）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；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、指导和支持员工努力提高质量管理体系的 有效性；i

32、）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。in esscanhe5.1.1.1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”）。See ISO 9001:2015 requireme nts.5.1.1 General 总则Top man ageme nt shall dem on strate leadership and commitme nt with respect to the quality man

33、ageme nt system by:a) tak ing acco un tability for the effect iven ess of the quality man ageme nt system;b) en suri ng that the quality policy and quality objectives are established for the quality man ageme nt system and are compatible with the con text and strategic direct ion of the orga ni zati

34、 on;c) ensuring the integration of the quality managementsystem requirements into the organization s buprocesses;d) promoting the use of the process approach and risk -based thinking;e) en suri ng that the resources n eeded for the quality man ageme nt system are available;f) com mun icati ng the im

35、porta nee of effective qualityman ageme nt and of con formi ng to the quality man ageme nt system requireme nts;g) en suri ng that the quality man ageme nt system achieves its inten ded results;h) en gagi ng, direct ing and support ing pers ons to con tributeto the effect iven ess of the qualityman

36、ageme nt system;i) promoti ng improveme nt;j) support ing other releva nt man ageme nt roles todem on strate their leadership as it applies to their areas of resp on sibility.NOTE Refere nee to“ bus in ess ” in this Intern ati onal Standarbe interpreted broadly to mean those activities that are core

37、 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 shall define and implement corporate responsibility policies，including at a minimum an an ti-bribery policy，an employee code of

38、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 processes and support processes to evaluate and improve their effective ness and efficie ncy. The results o the process review act

39、ivities shall be in cluded as in put to the management review (see Section 9.3.2.1).5.1.1.2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）。5.1.1.3过程拥有者最高管理者应确定过程拥有者，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第7.2 条）.5.1.2以顾客为关注焦点见 ISO 9001:2015 的要求。最高管理者应通过

40、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服务符合性以及增强 顾客满意能力的风险与机遇；c）始终致力于增强顾客满意。5.2方针5.2.1建立质量方针见 ISO 9001:2015 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）包括对持续改进质量管理体系的承诺。5.2.2沟通质量方针见 ISO 9001:2015 的要求。5.1.1.3 Process ownersTop man a

41、geme 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 roles(see ISO 9001 Section 7.2).5.1.2 Customer focusSee ISO 9001:2015 requireme nts.Top man a

42、geme nt shall dem on strate leadership andcommitme nt with respect to customer focus by en suri ng 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 opport un ities that can affect con formity of products and

43、services and the ability to enhance customer satisfact ion are determ ined and addressed;c) the focus on enhancing customer satisfact ion is mai ntai ned.5.2 Policy5.2.1 Establish ing the qualify policySee ISO 9001:2015 requireme nts.Top man ageme nt shall establish, impleme nt and maintain a qualit

44、y 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 commitme nt to con ti nual improveme nt of th

45、e quality man ageme nt system.5.2.2 Communi cati ng the quality policySee ISO 9001:2015 requireme nts.The quality policy shall:a) be available and be maintained as docume ntedin formati on;b) be com muni cated, un derstood and applied with in the orga ni zati on;c) be available to releva nt in teres

46、ted parties, as appropriate.5.3 Organizational roles， responsibilities and authoritiesSee ISO 9001:2015 requirements.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。Top man ageme nt shall en sure that the resp on sibilities and authorities for releva nt roles are assig ned, com muni cated a

47、nd un derstood with in the orga ni zati on.Top man ageme nt shall assig n the resp on sibility and authority for:5.3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；c）报告质量管理体系的绩效和改进机会，特别向最 高管理者；d）确保在整个组织推动以顾客为关注焦点；e）确保在策划和实施质量管理体系的

48、更改时保持其 完整性。a) en suri ng that the quality man ageme nt system con forms to the requireme nts of this Intern ati onal Stan dard;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 opport un ities for improvem

49、e nt (see 10.1), in particular to top man ageme nt;d) en suri ng the promoti on of customer focus throughout the orga ni zati on;e) en suri ng that the in tegrity of the quality man ageme nt system is mai ntai ned whe n cha nges to the quality man ageme nt system are pla nned and impleme nted.5.3.1

50、Organizational roles， responsibilities，and authorities - suppleme ntal5.3.1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。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。Top man ageme nt shall assig n pers onnel with the resp on sibility and authority to en sure that cu

51、stomer 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 analysis logistics informati

52、on， 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:a) personnel responsible for conformity to product requireme nts have the authority to stop shipme nt and stop product ion to correct

53、 quality problems ；5.3.2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NOTE Due to the process desig n in some in dustries 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 prev

54、e nted.b) personnel with authority and responsibility for corrective action are promptly in formed of products or processes that do not conform to requireme nts toen sure that nonconforming product is not shipped to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

55、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策划6.1风险和机遇的应对措施6.1.1 和 6.1.2见 ISO 9001:2015 的要求。6.1.1策划质量管理体系时，组织应考虑 4.1所描述 的因素和4.2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）避免或减少不利影响；d）实现改进。6.1.2组织应策划：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些 措施（见4.4）；2）评价这些措施的有效性。所采取的应

56、对风险和机遇的措施应与其对产品和服务符合性的潜在影响相适应。注1:应对风险的选择可以包括：避免风险、为获 取机遇而接受风险、消除风险源、改变风险的可能 性和结果、分担风险或经过决策而延缓风险。注2：机遇可以带来新实践的采用、推出新产品、打 开新市场、获得新客户、建立合作关系、使用新技 术以及能够解决组织或其他顾客需求的其他有利可the customer and that all pote ntial nonconforming product is identified and contained；c) product ion operati ons across all shifts are

57、 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 opport un ities6.1.1 and 6.1.2See ISO 9001:2015 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 opport un ities that n eed to be addressed to:a) give