IATF16949中英文对照版202110

1、精品文档4组织的环境4.1理解组织及其环境见 ISO 9001:2021 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 9001:2021 的要求。由于相关方对组织持续提供满足

2、顾客和适用的法律 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 9001:2021 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；b在4.2中涉及的有关相关方要求；4 Con text of the orga ni zati on4.1 Un dersta nding the orga ni zatio n and its con text

3、See ISO 9001:2021 requirements.The orga ni zati on shall determ ine exter nal and internal issues that are rel evant to its purpose and its strategicdirect ion and that affect its ability to achieve the intend ed result(s) of its quality management system. The orga ni zati on shall mon itor and revi

4、ew in formati on about these exter nal and internal issues.NOTE 1 Issues can includ e positive and negative factors or con diti ons for con sid erati on.NOTE 2 Und ersta nding the exter nal con text can be facilitated by con sid ering issues aris ing from legal,tech no logical, competitive, market,

5、cultural, social and econo mic en vir onmen ts, whether intern ati on al, n ati on al,regi onal or local. NOTE 3 Und ersta nding the in ter nal con text can be facilitated by consid ering issues related to values, culture*nowledge and performa nee of the orga ni zati on.4.2 Un dersta nding the n eed

6、s and expectatio ns of in terested partiesSee ISO 9001:2021 requireme nts.Due to their effect or pote ntial effect on the orga ni zati on ability to con siste ntly provide products an dservices that meet customer and applicable statutory and regulatory requireme nts, the orga ni zati on shall determ

7、 ine:a) the in 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 n

8、trequireme nts.4.3 Determi ning the scope of the quality man ageme nt systemSee ISO 9001:2021 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:a)

9、 the exter nal and internal issues referred to in 4.1;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。systembility orb) the requireme nts of releva

10、 nt in terested parties referred to in 4.2;c) the products and services of the orga ni zati on.The orga ni zati on shall apply all the requireme nts of this International Standard if they are applicablewithin the determ ined scope of its quality man ageme nt system.The sco pe of the organization'

11、; s quality managementshall be available and be maintained asd ocumented in formati on. The scope shall state the types of products and services covered, and providejustificati on for any requireme nt of this Intern ati onal Stan dard that the orga ni zati on determ ines is no tapplicable to the sco

12、pe of its quality man ageme nt system.Con formity to this Intern ati onal Stan dard may only be claimed if the requireme nts determ ined as no tbe ing applicable do not affect the organization' s aresp on sibility to en sure the con formity of itsproducts and services and the enhan ceme nt of cu

13、stomer satisfacti on.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 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。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4.3.1 Determi ning the scope of the quality man ageme nt system

14、- suppleme ntalSupport ing fun cti on s, 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 de

15、sig n and development 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 nts Customer-specific requireme

16、 nts shall be evaluated and in cluded in the scope of the orga ni zations quality man ageme nt system.See ISO 9001:2021 requireme nts441见 ISO 9001:2021 的要求。组织应按本标准的要求建立、实施、保持和持 续改良质量管理体系，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

17、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改良过程和质量管理体系。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

18、关特性的识别；e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；4.4.1 The orga ni zati on shall establish, impleme nt, maintain and continu ally improve a qualityma nageme nt system, in cludi ng the processes n eeded and their in teract ions, in accorda nee with therequireme nts of this Intern ati onal Stan dard.The

19、orga ni zati on shall determ ine the processes n eed ed for the quality man ageme nt system and theirapplicati 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 processe

20、s;c) determ ine and apply the criteria and methods (in clud ing mon itori ng, measureme nts and relatedperforma neein 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 and en sure their availability;e) assign

21、 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 impleme nt any cha nges n eeded to en sure that these processes achievetheir intend ed results;h) improve the

22、 processes and the quality man ageme nt 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( ).4.

23、4.1.2 Product safetyThe orga ni zatio n shall have docume nted processes fo 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 pr

24、oduct-safety requireme nts；b) customer notification of requirements in item a)；g反响方案见第9.1.1.1 条;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 整个供给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整个供给链中按制造批次至少的产品可 追溯性见第8.52

25、1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。在必要的程度上，组织应：见 ISO 9001:2021 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。c) special approvals for design FMEAd) identification of product safety-related characteristics；e) identification and controls of safety-related characteristics of product and

26、at the point of manu facture ；f) special approval of control plans and process FMEAsg) reacti on pla ns( see Sect ion 9.1.1.1 ；h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification；i) training identified by the orga

27、nization 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 prior to implementation , )；k) transfer of requirements with regard to product safety throughout the supply chain, including cus

28、tomer-desig nated sources (see Secti on 8.4.3.1 ；l) product traceability by manufactured lot (at a minimum) throughout the supply chain ()；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 orga n

29、i zati onbinternal processes.See ISO 9001:2021 requireme nts.4.4.2 To the extent necessary, the organization shall:a) maintain documented information to support the operatio n of its processes;b) retain d ocumented information to have confidence thatthe processes are being carried out as pla nn ed.5

30、领导作用5.1领导作用与承诺总贝U见 ISO 9001:2021 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推动改良；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

31、 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、员工行为准那么以及道德准那么升级政策举报政策。5 Leadership5.1 Leadership and commitme nt5.1.1 Ge neralSee ISO 9001:2021 requireme nts.5.1.1General 总那么Top man ageme nt shall dem on strate leadership and commitme nt with respect to the qualityma nageme nt syste

32、m by:a) tak ing acco un tability for the effective ness 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 ntsystem and are compatible with the con text and strategic direct ion of the orga ni zati on;c) ensuring

33、the integration of the quality managementsystem requirements into the organization' sbiprocesses;d) promot ing the use of the process approach and risk-based thinking;e) en suri ng that the resources n eed ed for the quality man ageme nt system are available;f) com muni cati ng the importa nee o

34、f effective qualityman ageme nt and of con formi ng to the qualityma nageme nt system requireme nts;g) en suri ng that the quality man ageme nt system achieves its intend ed results;h) en gagi ng, direct ing and support ing pers ons to con tribute to the effective ness of the qualityman ageme nt sys

35、tem;i) promoti ng improveme nt;j) support ing other rel eva nt man ageme nt roles to dem on strate their leadership as it applies to theirareas of resp on sibility.NOTE Refere nee to“ bus in ess in this Intern ati onal Sta ndcan be in terpreted broadly to mean thoseactivities that arecore to the pur

36、poses of t he organization' s existenee, wheththe organization 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 anti-bribery policy，an employee code of过程有效性和效

37、率最高管理者应评审产品实现过程和支持过程，以评 价并改良过程有效性和效率。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.以顾客为关注焦点见 ISO 9001:2021 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。5.2方针建立质量方

38、针见 ISO 9001:2021 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包括对持续改良质量管理体系的承诺。con duct，and an ethics escalati on policy(“whistle-blowing policy ).5.1.1.2 Process effective ness and efficie ncyTop management shall review the product realization processes and support p

39、rocesses to evaluate and improve their effectiveness and efficiency. The results of the process review activities shall be in cluded as in put to the man ageme nt review ( see Secti on 9.3.2.1.).5.1.1.3 Process ownersTop man ageme nt shall ide ntify process owners who are resp on sible for man agi n

40、g the orga ni zati on's 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 9001:2021 requireme nts.Top man ageme nt shall dem on strate leadership and commitme nt with respec

41、t to customer focus bye nsuri ng that:a) customer and applicabl e statutory and regulatory requireme nts are determ in ed, un derstood andcon siste ntly met;b) the risks and opport un ities that can affect con formity of products and services and the ability toe nhance customer satisfact ion are det

42、erm ined and addressed;c) the focus on enhancing customer satisfact ion is mai ntai ned.5.2 Policy5.2.1Establishi ng the qualify policySee ISO 9001:2021 requireme nts.Top management shall establish, impl ement and maintain a quality policy that:a) is appropriate to the purpose and con text of the or

43、ga ni zati on and supports its strategic direct ion;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 continual improveme nt of the522沟通质量方针见 ISO 9001:2021 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

44、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 9001:2021 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良时机，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。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

45、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。quality man ageme nt system.5.2.2 Communi cat ing the quality policy See ISO 9001:2021 requirements.The quality policy shall:a) be available and be maintained as docume nted in formati on;b) be com muni cated, un derstood and applied with in the orga ni zati on;c) be av

46、ailable to releva nt in terested parties, as appropriate.5.3 Organizational roles， responsibilities and authoritiesSee ISO 9001:2021 requireme nts.Top man ageme nt shall en sure that the resp on sibilities and authorities for releva nt rol es are assig ned,com muni cated and un derstood with in the

47、orga ni zati on.Top man ageme nt shall assig n the resp on sibility and authority for:a) en suri ng that the quality man ageme nt system con formsto the requirements of this InternationalStandard;b) ensuring that the processes are delivering their intended outputs;c) report ing on the performa nee o

48、f the quality man ageme nt system and on opport un ities forimproveme nt (see 10.1), i n particular to top man ageme nt;d) ensuring the promotion of customer focus throughout the orga ni zatio n;e) ensuring that the integrity of the quality management system is mai ntai ned whe n cha nges to thequal

49、ity man ageme nt system are pla nned and impl eme nted.5.3.1Organizational roles，responsibilities，andauthorities - suppleme ntalTop man ageme nt shall assig n pers onnel with the resp on sibility and authority to en sure that customer requireme nts are met. These assig nments shall be documented. Th

50、is includes but is not limited to the selection of special characteristics setting quality objectives and related training, corrective andPreventive actions, product design and development，capacity analysis logistics information， customer scorecards and customer portals.532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

51、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。5.3.2 Responsibility and authority for product requireme nts and corrective actions Top man ageme nt sha

52、ll 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 quality problems；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

53、 affected batch must be contained and shipme nt to the customer preve nted.b) personnel with authority and responsibility for corrective acti on 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 a

54、nd that all pote ntial nonconforming product is identified and contained ；c) production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for， ensuring conformity to product6筹划6.1风险和机遇的应对措施6.1.1 和 见 ISO 9001:2021 的要求。筹划质量管理体系时，组织应考虑4.1所描述的 因素和4.2所提及的要求

55、，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实现改良。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些 措施见4.4；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服requireme nts.6 Pla nning6.1 Actions to address risks and opport un ities6.1.1See ISO 9001:2021 requireme nts.6.1.1 When pla nning for the quality man a

56、geme nt system, the orga ni zatio n shall con sider the issuesreferred to in 4.1 and the requireme nts referred to in 4.2 and determ ine the risks and opport un ities that need to be addressed to:a) give assura nee that the quality man ageme nt system can achieve its intend ed result(s);b) enhance d

57、 esirable effects;c) prevent, or reduce, und esired effects;d) achieve improveme nt.6.1.2 The orga ni zati on shall pla n:a) actions to address these risks and opport un ities;b) how to:1) in tegrate and impleme nt the actions into its quality man ageme nt system processes (see 4.4);2) evaluate the effect iven ess of these actions.Actions taken to ad dress risks and opportunities shall be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：防止风险、为获取 机遇而接受风险、消