8.4 Control of externally provided processes, products and services (8.4.1)

8. OPERATION

8.4 Control of externally provided processes, products and services

8.4.1 General

The organization shall ensure that externally provided processes, products and services conform to requirements.

The organization shall determine the controls to be applied to externally provided processes, products and services when:

• a) products and services from external providers are intended for incorporation into the organization’s own products and services;
• b) products and services are provided directly to the customer(s) by external providers on behalf of the organization;
• c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

Cross reference
Clause 9.1.3 (Performance analysis and evaluation)