A.5 Applicability
This International Standard does not refer to “exclusions” in relation to the applicability of its
requirements to the organization’s quality management system. However, an organization can review
the applicability of requirements due to the size or complexity of the organization, the management
model it adopts, the range of the organization’s activities and the nature of the risks and opportunities
it encounters.
The requirements for applicability are addressed in 4.3, which defines conditions under which an
organization can decide that a requirement cannot be applied to any of the processes within the scope
of its quality management system. The organization can only decide that a requirement is not applicable
if its decision will not result in failure to achieve conformity of products and services.