8.4 Control of externally provided processes, products and services (8.4.2)

8. OPERATION

8.4 Control of externally provided processes, products and services

8.4.2 Type and extent of control

The organization shall ensure that externally provided processes, products and services do not adversely affect the organization’s ability to consistently deliver conforming products and services to its customers.

The organization shall:

• a) ensure that externally provided processes remain within the control of its quality management system;
• b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
• c) take into consideration:
• 1) the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements;
• 2) the effectiveness of the controls applied by the external provider;
• d) determine the verification, or other activities, necessary to ensure that the externally provided processes, products and services meet requirements.