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
2、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。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； 4 Context of the organization4.1 Understanding the organization and its context See ISO 9001:2015 re
3、quirements.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 exter
4、nal 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, wheth
5、er 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. 4.2 Understanding the needs and expectations of interested partiesSee ISO 9001:2015 requirements
6、.Due to their effect or potential effect on the organizations 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
7、) 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.4.3 Determining the scope of the quality management systemSee ISO 9001:2015 requireme
8、nts.The organization shall determine the boundaries and applicability of the quality management systemto 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
9、 to in b) 在 4.2中涉及的有关相关方要求；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
10、。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。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4.4.14.2;c) the products and services of the organization.The organization shall apply all the requirements of this International Standard
11、 if they are applicable within the determined scope of its quality management system.The scope of the organizations 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 fo
12、r 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 organizations abili
13、ty or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.4.3.1 Determining the scope of the quality management system - supplementalSupporting functions，whether on-site or remote（such as design centres，corporate headquarters，and distribu
14、tion centres），shall be included in the scope of the Quality Management System（QMS）.The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001，Section 8.3. The exclusion shall be justified and maintained as documented infor
15、mation（see ISO 9001，Section 7.5）.Permitted exclusions do not include manufacturing process design.4.3.2 Customer-specific requirementsCustomer-specific requirements shall be evaluated and included in the scope of the organizations quality management system.4.4 Quality management system and its proce
16、sses4.4.1See ISO 9001:2015 requirements4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including 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
17、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
18、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）；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；the processes needed and their interactions, in accordance with the requirements of this International Standa
19、rd.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) deter
20、mine 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 a
21、nd 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 mana
22、gement system.4.4. 1. 1 Conformance of products and processesThe 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）.4.4.1.2 Product safetyThe
23、organization shall have documented processes for the management of product-safety related products and manufacturing processes，which shall include but not be limited to the following，where applicable:a）identification by the organization of statutory and regulatory product-safety requirements；b）custo
24、mer notification of requirements in item a）；c） special 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 ofmanufacture；f） special approval of control plans and process i） 组织
25、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 8.3.6 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 8.4.3.1 条）；l） 整个供应链中按制造批次（至少）的产品可追溯性（见第 8.5.2.1 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 9001:2015 的要求。a) 保持形成文件的信息以支持过程运行； b) 保留
26、确认其过程是按策划进行的形成文件的信息。FMEAs；g） reaction plans（see Section 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 organization or customer for personnel involved in product 画 safety re
27、lated products and associated manufacturing processes；j） changes of product or process shall be approved prior to implementation，including evaluation of potential effects on product safety from process and product changes（see ISO 9001，Section 8.3.6）；k）transfer of requirements with regard to product
28、safety throughout the supply chain，including customer-designated sources（see Section 8.4.3.1）；l） product 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 requirements
29、 or documents may be required by the customer or the organizations internal processes.4.4.2See ISO 9001:2015 requirements.4.4.2 To the extent necessary, the organization shall:a) maintain documented information to support the operation of its processes;b) retain documented information to have confid
30、ence that the processes are being carried out as planned. 5 Leadership5.1 Leadership and commitment5.1.1 GeneralSee ISO 9001:2015 requirements.5.1.1 General 总则Top management shall demonstrate leadership and 5 领导作用5.1 领导作用与承诺5.1.1 总则见 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；
31、 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。5.1.1.1 公司责任组织应明确并实施公司责任
32、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”）。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 management system and are compa
33、tible with the context and strategic direction of the organization;c) ensuring the integration of the quality management system requirements into the organizations business processes;d) promoting the use of the process approach and risk-based thinking;e) ensuring that the resources needed for the qu
34、ality management system are available;f) communicating the importance of effective quality management and of conforming to the quality management system requirements;g) ensuring that the quality management system achieves its intended results;h) engaging, directing and supporting persons to contribu
35、te to the effectiveness of the qualitymanagement system;i) promoting improvement;j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.NOTE Reference to “business” in this International Standard can be interpreted broadly to mean
36、 those activities that are core to the purposes of the organizations existence, whether the organization is public, private, for profit or not for profit.5.1.1.1 Corporate responsibilityThe organization shall define and implement corporate responsibility policies，including at a minimum an anti-bribe
37、ry policy，an employee code of conduct，and an ethics escalation policy（“ whistle-blowing policy”）.5.1.1.2 Process effectiveness and efficiencyTop management shall review the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. The results of
38、the process review activities shall be included as input to the management review（see Section 9.3.2.1.）.5.1.1.3 Process ownersTop management shall identify process owners who are 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 9.3.2.1 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
39、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
40、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。responsible for managing the organizations processes and related outputs. Process owners shall understand their roles and be competent to perform those roles（see ISO 9001，Section 7.2）.5.1.2 Customer focusSee ISO 9001:201
41、5 requirements.Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;b) the risks and opportunities that can affect conformity of prod
42、ucts and services and the ability to enhance customer satisfaction are determined and addressed;c) the focus on enhancing customer satisfaction is maintained.5.2 Policy5.2.1 Establishing the qualify policy See ISO 9001:2015 requirements.Top management shall establish, implement and maintain a qualit
43、y policy that:a) is appropriate to the purpose and context of the organization and supports its strategic direction;b) provides a framework for setting quality objectives;c) includes a commitment to satisfy applicable requirements;d) includes a commitment to continual improvement of the quality mana
44、gement system.5.2.2 Communicating the quality policy See ISO 9001:2015 requirements.The quality policy shall:a) be available and be maintained as documented information;b) be communicated, understood and applied within the organization;c) be available to relevant interested parties, as appropriate.5
45、.3 Organizational roles，responsibilities and authorities See ISO 9001:2015 requirements.Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.Top management shall assign the responsibility and author
46、ity for:a) ensuring that the quality management system conforms to 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 9001:2015 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
47、顾客为关注焦点； e) 确保在策划和实施质量管理体系的更改时保持其完整性。5.3.1 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。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the requirements of this International Standard;b) ensur
48、ing that the processes are delivering their intended outputs;c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management;d) ensuring the promotion of customer focus throughout the organization;e) ensuring that the
49、integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.5.3.1 Organizational roles，responsibilities，and authorities - supplementalTop management shall assign personnel with the responsibility and authority to ensure that customer requirements are met. These assignments 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 in
