Guidance on Clause 1.2 - 'Application' (cont.)

Justification of exclusions

If certain requirements cannot be applied they need to be defined and justified within the Quality Manual. Depending upon the Client's scope, these might include :

Some clients may, for example, consider excluding Design and development (Cl. 7.3) entirely because they do not perform any part of this process.

However, particular care is needed if this process is outsourced (or "sub-contracted") to an external organisation. In this case there is not an adequate justification for excluding it from the QMS because the Client retains overall management responsibility.

Instead, sufficient control must be demonstrated to ensure that process(es) such as design & development or manufacturing are performed according to the relevant requirements of ISO 9001:2008. This will depend on the nature of the process(es) and the risk involved. The Purchasing clause (Cl. 7.4) should be applied to monitor output of sub-contracted processes.