All parts of sections 4, 5, 6 and 8 of ISO 9001 apply in their entirety to all organisations, and there are no circumstances under which an organisation may claim exclusion to any parts of these sections. Exclusions to parts of section 7 can be considered, but this is only permissible where the requirement does not apply to the organisation (refer to clause 1.2 of ISO 9001). That is, if the organisation has no design function, there is no design work to be controlled or audited, so it is permissible to exclude clause 7.3 from the scope of certification. It is not permissible to exclude a design function from scope because it is very poor and you would rather it wasn’t assessed

The following table summarises the circumstances under which an organisation may consider excluding a part of section 7 from the scope of certification. The most common exclusions are clauses 7.3, 7.6, 7.5.2 and 7.5.4:

(more…)