The clauses of the standard

Guidance on Clause 1.2 - 'Application'

Scope of Quality Management System

It is important to recognise that the Scope (Clause 1) of ISO 9001:2008 defines the scope of the standard itself, and should not be confused with the scope of the Client's QMS.

The scope of the Client's QMS should be based on :

- their realisation processes,

- the results of risk assessment,

- commercial considerations, and

- contractual/statutory/regulatory requirements.

In practice this would be covered by the 'Scope of Registration' as it appears on the Client's Certification / Registration Certificate. In some instances there will be a need for more precise "scope statements"; QEC can advise upon this either prior to an initial assessment or during surveillance visits.