The organization ensures that externally provided processes, products and services do not negatively affect the ability to deliver conforming products and services to its customers.
To enable this, the organization documents in its quality management system for each externally provided process, product or service:
- controls applied to this external provider
- controls applied to the outputs of this external provider
- verification necessary to ensure that the externally provider (and outputs) meet requirements
The controls should be proportionate to the potential impact of the related activities on organization's quality and take into account the effectiveness of the controls applied by the external provider themselves.