4.3 Determining the Scope of the Management System

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Determining the Scope of the Management System

This requirement is comparable to ISO 9001:2008 Clause 4.2.2 – Quality Manual. You will need to verify that your organisation’s scope exists as documented information (which may be in the form of a Quality Manual) in accordance with Clause 7.5.1a. Look for confirmation that your organization has determined the boundaries and applicability of the QMS to establish its scope with reference to any external and internal issues referred to in 4.1 and the requirements of relevant interested parties referred to in 4.2.

Check that this has been done in consideration of your organisation’s context and your products. You should review any exclusions previously noted under ISO 9001:2008 for ongoing suitability. Check that legacy issues which limited scope and omitted activities do not affect product conformity. Check that they are recorded and that the rationale for the exclusion is stated and justified.


*Under construction*