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.