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4 组织的环境 4.1 理解组织及其环境 见ISO 9001:2015的要求。 4 Context of the organization 4.1 Understanding the organization and its context See ISO 9001:2015 requirements. The organization shall determine external and internal issues that are relevant to its purpose and 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 consideration. 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 considering issues related to values, culture, knowledge and performance of the organization. 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 Understanding the needs and expectations of 4.2 理解相关方的需求和期望 见ISO 9001:2015的要求。 interested parties See ISO 9001:2015 requirements. Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review information about these interested parties and their relevant requirements. 由于相关方对组织持续提供满足顾客和适用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。 4.3 Determining the scope of the quality management system See ISO 9001:2015 requirements. The organization shall determine the boundaries and applicability of the quality management system to establish its scope. When determining this scope, the organization shall consider: a) the external and internal issues referred to in 4.1; b) the requirements of relevant interested parties referred to in 组织应确定质量管理体系的边界和适用性，以确定其范围。 在确定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； c) 组织的产品与服务。 4.2; c) the products and services of the organization. The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. 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 Determining the scope of the quality management system - supplemental Supporting functions，whether on-site or remote（such as design centres，corporate headquarters，and 4.3.1 确定质量管理体系的范围----补充 distribution centres），shall be included in the scope of the Quality Management System（QMS）. 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）The only permitted exclusion for this Automotive QMS 的范围中。 Standard relates to the product design and 本汽车QMS标准唯一允许的删减是ISO 9001第8.3条development requirements within ISO 9001，Section 中的产品设计和开发要求。删减应以形成文件的信息8.3. The exclusion shall be justified and maintained as （见ISO 9001第7.5条）的形式进行证明和保持。 documented information（see ISO 9001，Section 7.5）. 允许的删减不包括制造过程设计。 Permitted exclusions do not include manufacturing process design. 4.3.2 Customer-specific requirements Customer-specific requirements shall be evaluated and included in the scope of the organization’s quality 4.3.2顾客特定要求 management system. 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 Quality management system and its processes 4.4.1 See ISO 9001:2015 requirements 4.4 质量管理体系及其过程 4.4.1 4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard. 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The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: a) determine the inputs required 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 related performance indicators) needed to ensure the effective operation and control of these processes; d) determine the resources needed for these processes and ensure their availability; e) assign the responsibilities and authorities for these processes; f) address the risks and opportunities as determined in accordance with the requirements of 6.1; 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. 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 4.4. 1. 1 Conformance of products and processes The organization shall ensure conformance of all products and processes，including service parts and those that are outsourced，to all applicable customer，statutory，and regulatory requirements（see Section 8.4.2.2）. 组织应确保所有的产品和过程，包括服务件及外包的产4.4.1.2 Product safety 品和过程，符合一切适用的顾客和法律法规要求（见The organization shall have documented processes for 8.4.2.2条）。 the management of product-safety related products and manufacturing processes，which shall include but not be limited to the following，where applicable: 4.4.1.2 产品安全 a）identification by the organization of statutory 组织应有形成文件的过程，用于与产品安全有关的产品and regulatory product-safety requirements； 和制造过程管理；形成文件的过程包括但不限于（在适 b）customer notification of requirements in item 用情况下）： a）； a） 组织应对产品安全法律法规要求的识别； c）special approvals for design FMEA； b） 向顾客通知a）项中的要求； d）identification of product safety-related c） 设计FMEA的特殊批准； characteristics； d） 产品安全相关特性的识别； e）identification and controls of safety-related e） 产品及制造时安全相关特性的识别和控制； characteristics of product and at the point of f） 控制计划和过程FMEA的特殊批准； manufacture； g） 反应计划（见第9.1.1.1条）； h） 包括最高管理者在内的，明确的职责，升级过 f）special approval of control plans and process 程和信息流的定义，以及顾客通知； FMEAs； i） 组织或顾客为与产品安全有关的产品和相关 g）reaction plans（see Section 9.1.1.1）；