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Guidance on Clause 1.2 - 'Application'

 

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Scope of Quality Management System

It is important to recognise that the Scope (Clause 1) of ISO 9001:2000 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 :

  • the nature of the organisation's products
  • 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.

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