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初中化学必背知识点
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 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 purpo 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 the 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 consideri橡皮怎么读英语
ng 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.
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。
4.2 Understanding the needs and expectations of interested parties
See ISO 9001:2015 requirements.
Due to their effect or potential effect on the organization’s ability to consistently provide products and rvices 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 the interested parties that are relevant to the quality management system.
The organization shall monitor and review information about the interested parties and their relevant requirements.
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；
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 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 4.2;
c) the products and rvices 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 rvices 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 determi
ned as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and rvices and the enhancement of customer satisfaction.
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 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。
4.3.1 Determining the scope of the quality management system - supplemental
Supporting 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 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 information（e ISO 9001，Section 7.5）.
Permitted exclusions do not include manufacturing process design.
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。
4.3.2 Customer-specific requirements
Customer-specific requirements shall be evaluated and included in the scope of the organization’s quality management system.
4.4 质量管理体系及其过程
4.4.1组织应按本标准的要求建立
