ISO9001-GBT19001-2015FDIS中英文对照版(3)

3 Terms and definitions术语和定义【3】

For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

本标准采用ISO 9000:2015中的术语和定义。

4 Context of the organization组织情景【4】

4.1 Understanding the organization and its context理解组织及其情景【4】

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.

组织应确定与其宗旨和战略方向有关且影响质量管理体实现其预期结果的能力的内部和外部情况

The organization shall monitor and review the information about these external and internal issues. 组织应监视和评审有关内部和外部情况的信息

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

注1 情况可能是正面或负面的因素或要考虑的状况；

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.

注2：可以通过考虑源于国际、国家、地区或本地的法律、技术、竞争、市场、文化、社会和经济环境的情况，促进对外部情景的了解。

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

注3 可以通过考虑与价值、文化、知识和组织业绩表现相关的问题来来促进（帮助、方便）对这些内部和外部背景的理解。

4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望【4】

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:

由于对对组织持续提供满足顾客和适用法律法规要求的产品和服务的能力的影响或潜在影响，组织应确定 a) the interested parties that are relevant to the quality management system;

与质量管理体系有关的相关方

b) the requirements of these interested parties that are relevant to the quality management system. The organization shall monitor and review the information about these interested parties and their relevant requirements.

与质量管理体系有关的相关方的要求

组织应监视和评审有关相关方及有关要求有关的信息。

4.3 Determining the scope of the quality management system确定质量管理体系的范围

【1.2 4.2.2】

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:

组织应确定质量管理体系的边界和适用性来建立其范围。

在确定质量管理体系范围时，组织应考虑：

a) the external and internal issues referred to in 4.1;

在4.1涉及的外部和内部情况

b) the requirements of relevant interested parties referred to in 4.2;

在4.2中涉及的有关相关方要求

c) the products and services of the organization.

组织的产品和服务

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.

如本标准的要求在确定的范围内适用，组织应应用本标准的所有要求。

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.

组织的质量管理体系范围应可获取并保持文件化信息。范围应说明质量管理体系所覆盖的产品和服务，并对组织确定不适用于管理体系范围的本标准的要求说明正当理由。

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.

当被确定为不适用的要求不影响组织确保产品和服务的符合性以及增强顾客满意的能力或责任时，才能声称符合本标准的要求。

4.4 Quality management system and its processes质量管理体系及其过程【4 4.1】

4.4.1The 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.

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。

The organization shall determine the processes needed for the quality management system and their application throughout the organization and shall:

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) determine the inputs required and the outputs expected from these processes;

确定这些过程所需的输入和期望的输出；

b) determine the sequence and interaction of these processes;

确定这些过程的顺序和相互作用；

c) determine the criteria, methods, including measurements and related performance indicators needed to

ensure the effective operation, and control of these processes;

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) determine the resources needed and ensure their availability;

确定这些过程所需的资源并确保其可用性；

e) assign the assignment of the responsibilities and authorities for these processes;

规定这些过程的职责和权限；

f) address the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them;

应对按照6.1的要求确定的风险和机会；

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