4.3、确定质量管理体系的范围

组织应确定质量管理体系的边界和适用性，以确定其范围。

在确定范围时，组织应考虑：

a. 内部和外部因素，见4.1；

b. 有关相关方的要求，见4.2；

c. 组织的产品和服务。

如果本标准的全部要求适用于组织确定的质量管理体系范围,组织应遵循本标准的全部要求。

组织的质量管理体系范围应作为形成文件的信息,可获得并得到保持。该范围应描述所覆盖的产品和服务类型，如果组织确定本标准的某些要求不适用于其质量管理体系范围，应说明理由。

除非组织所确定的不适用于其质量管理体系的标准要求不影响组织确保其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要求。

4.3、Determining the scope of the quality management system

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 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.