iatf16949中英文对照版1013新版.docx

1、iatf16949中英文对照版1013新版4组织的环境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系统预期结果的各种外面和内部因素。组织对付这些内部和外面因素的相关信息进行监察和评审。注1：这些因素能够包括需要考虑的正面或负面的因素或条件；注2：能够经过考虑源于国际、国家、地区或当地的各种法律法规、技术、竞争、市场、文化、社会和经济因素的情况，有助于理解外面环境。注3：能够经过考虑组织的价值观、文化、知识和组织绩效等相关因素情况，有助于理解内部环境。理解相关方的需求和希望见 ISO 9001:2021 的要求。由于相关方对组织连续

2、供给满足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藏影响，因此，组织应确定：a)与质量管理系统相关的相关方；b)这些相关方的要求。组织对付这些相关方及其要求的相关信息进行监察和评审。4 Context of the organizationUnderstanding the organization and its contextSee ISO 9001:2021 requirements.The organization shall determine external and internalissues that are relevant to its purpose and

3、 its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.The organization shall monitor and review information about these external and internal issues.NOTE 1 Issues can include positive and negative factors or conditions for considerati

4、on.NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal,technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.NOTE 3 Understanding the internal context can be facilitated by

5、considering issues related to values, culture, knowledge and performance of the organization.Understanding the needs and expectations of interested partiesSee ISO 9001:2021 requirements.Due to their effect or potential effect on the organization s ability to consistently provideproducts and services

6、 that meet customer and applicable statutory and regulatory requirements, the organization shall determine:确定质量管理系统的范围见 ISO 9001:2021 的要求。组织应确定质量管理系统的界线和适用性，以确定其范围。在确定质量管理系统范围时，组织应试虑：a)在中涉及的各种外面和内部因素；b)在中涉及的相关相关方要求；c)组织的产品与效劳。关于本标准中适用于组织确定的质量管理系统范围的所有要求，组织应予以推行。组织的质量管理系统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系统

7、所覆盖的产品和效劳种类，假设组织认为其管理系统范围的应用范围不适用本标准的某些要求，应说明原因。那些不适用组织的质量管理系统要求，不能够影响组织保证产品和效劳合格以及增强顾客满意的能力或责任，否那么不能够声称吻合本标准的要求。a)the interested parties that are relevant to the quality management system;b) the requirements of these interested parties that arerelevant to the quality management system.The organizat

8、ion shall monitor and review information about these interested parties and their relevant requirements.Determining the scope of the quality management systemSee ISO 9001:2021 requirements.The organization shall determine the boundaries and applicability of the quality management systemto establish

9、its scope.When determining this scope, the organization shall consider:a)the external and internal issues referred to in ;b)the requirements of relevant interested parties referred to in ;c)the products and services of the organization.The organization shall apply all the requirements of this Intern

10、ational Standard if they are applicable within the determined scope of its quality management system.The scope of the organizations quality managementsystem shall be available and be maintained asdocumented information.The scope shallstatethetypesof products and services covered, and providejustific

11、ationfor any requirement of thisInternationalStandard that the organization determines is notapplicable to the scope of its quality managementsystem.Conformity to this International Standard may only beclaimed if the requirements determined as not beingapplicabledo not affecttheorganizationsabilityo

12、rresponsibility to ensure the conformity of its productsand services and the enhancement of customersatisfaction.确定质量管理系统的范围 - 补充支持功能，无论其在现场或外面场所比方：设计中心、公司总部和配送中心 ，应包括在质量管理系统 QMS的范围中。本汽车 QMS标准唯一赞成的删减是 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。赞成的删减不包括制造过程设计。Determining the scope of t

13、he quality management system - supplementalSupporting functions ， whether on-site or remote such as design centres ， corporateheadquarters ， and distribution centres ，shallbe included in the scope of the Quality Management SystemQMS.The only permitted exclusion for this Automotive QMS Standard relat

14、es to the product design anddevelopment requirements within ISO 9001 ，Section . The exclusion shall be justified andmaintained as documented information see ISO9001，Section .Permitted exclusions do not include manufacturing process design.顾客特定要求对付顾客特定要求进行议论，并将其包括在组织的质量管理系统范围内。质量管理系统及其过程见 ISO 9001:20

15、21 的要求。组织应按本标准的要求建立、推行、保持和连续改良质量管理系统，包括质量管理系统所需的过程及其相互作用。组织应确定质量管理系统所需的过程及其在整个Customer-specific requirementsCustomer-specific requirements shall be evaluated and included in the scope of the organization s quality management system.Quality management system and its processesISO 9001:2021 requirement

16、sThe organization shall establish, implement, maintainand continually improve a quality management system,including the processes needed and their interactions,in accordance with the requirements of this International Standard.组织中的应用，组织应：a)确定这些过程所需的输入和希望的输出；b)确定这些过程的序次和相互作用；c)确定和应用所需的准那么和方法包括监察、测量和相

17、关的绩效指标，以保证这些过程的有效运行和控制；d)确定并保证获取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)应依照的要求确定风险和时机；g)议论这些过程，推行所需的改正，以保证这些过程实现预期的结果；h)改良过程和质量管理系统。The organization shall determine the processes neededfor the quality management system and their application throughout the organization, and shall:a)determine the inputs require

18、d and the outputs expected from these processes;b)determine the sequence and interaction of these processes;c)determine and apply the criteria and methods (including monitoring, measurements and relatedperformance indicators) needed to ensure the effectiveoperation and control of these processes;d)d

19、etermine the resources needed for these processes and ensure their availability;e)assign the responsibilities and authorities forthese processes;产品和过程的吻合性组织应保证所有的产品和过程，包括效劳件及外包的产品和过程，吻合所有适用的顾客和法律法规要求见条。产品安全组织应有形成文件的过程，用于与产品安全相关的f) address the risks and opportunities as determined inaccordance with t

20、he requirements of ;g)evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;h)improve the processes and the quality management system. 1. 1 Conformance of products and processesThe organizationshall ensure conformance of allproducts a

21、nd processes ， includingservice partsand those thatare outsourced ， toall applicablecustomer ，statutory，and regulatoryrequirementssee Section.Product safetyThe organization shall have documented processes for the management of product-safety relatedproducts and manufacturing processes ，whichshall in

22、clude but not be limited to the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 组织对付产品安全法律法规要求的鉴别；b 向顾客通知 a项中的要求；c 设计 FMEA的特别赞成；d 产品安全相关特色的鉴别；e 产品及制造时安全相关特色的鉴别和控制；f 控制方案和过程 FMEA的特别赞成；g 反响方案见第条 ；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；i 组织或顾客为与产品安全相关的产品和相关制造过程中涉及的人员确定的培训；j 产品或过程的改正在推行以前应获取赞成，包括对过程和产品改正带给产品安全的潜藏影响进行议论见

23、 ISO 9001 第条；k 整个供给链中关于产品安全的要求转移，括顾客指定的货源见第条 ；l 整个供给链中按制造批次最少的产品可追想性见第条 ；m 为新产品导入的经验教训。注：顾客也许组织内部程序可要求与安全相关的要求也许文件的特别赞成。following ， where applicable:aidentification by the organization of statutory and regulatory product-safety requirements ；b customer notification of requirements in item a ；c speci

24、al approvals for design FMEA ；d identification of product safety-relatedcharacteristics ；e identification and controls of safety-related characteristics of product and at the point ofmanufacture ；fspecial approval of control plans and process FMEAs；g reaction plans see Section ；h defined responsibil

25、ities ，definition of包 escalation process and flow of information ，including top management ， and customer notification ；itraining identified by the organization or customer for personnel involved in product 画 safety related products and associatedmanufacturing processes ；j changes of product or proc

26、ess shall beapproved prior to implementation ， including evaluation of potential effects on productsafety from process and product changessee ISO 9001，Section ；k transfer of requirements with regard toproduct safety throughout the supply chain ，including customer-designated sources seeSection ；l pro

27、duct traceability by manufactured lotat a minimumthroughout the supply chain see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办进行的形成文件的信息。Section ；mlessons learned for new product introduction.NOTE: Special approval of safety related requirements or documents may be required by thec

28、ustomer or the organization s internalprocesses.ISO 9001:2021 requirements.To the extent necessary, the organization shall:a)maintain documented information to support the operation of its processes;b)retain documented information to have confidence that the processes are being carried out as planne

29、d.5 LeadershipLeadership and commitmentGeneralSee ISO 9001:2021 requirements.General 总那么Top management shall demonstrate leadership and commitment with respect to the quality management system by:a)taking accountability for the effectiveness of the quality management system;b)ensuring that the quality policy and quality objectives are established for the quality management5领导作用领导作用与承诺总那么见 ISO 9001:2021 的要求。最高管理者应证明其对质量管理系统的领导作用和承诺，经过：a)对质量管理系统的有效性担当责任；b)保证拟定质量管理系统的质量目标和质量目标，并与组织环境和战略方向保持一致；c)保证将质量管理系统要求融入组织的业务过程；d)促使使用过程方法和基于风险的思想；e)保证获取质量管理系统所需的资源；f)沟通有效的质量管理系统和吻合质量管理系统要求的重要性；g)