Examples of requirements that may not be applicable in certain circumstances are requirements related to:

• Design and development: where the Organization has no responsibility for this activity;

 
• Customer property: where the Organization uses no customer property in its product realization processes;

 
• Control of monitoring and measuring devices:
where the Organization needs no monitoring or measuring devices to provide evidence of conformity of its products
(e.g. in some service organizations)

Where some product realization processes are outsourced or subcontracted to an external organization, they may not be excluded from the quality management systems (QMS). Instead, the Organization implementing the QMS must be able to demonstrate that it exercises sufficient control to ensure that such processes are performed according to ISO 9001 requirements.

The nature of this control depends on the nature of the outsourced process and the risk involved. It may include, for example, the specification and/or validation of processes, requirements for the supplier's QMS, on-site inspections and verifications and/or audit.