4.3 Determining the Scope of the Management System

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Plan

Determining the scope of the management system

This Step 1 in the ‘Plan’ stage of the ’PDCA’ cycle. Define, build, operate and improve your QMS. Your mangement system should define your organization’s goals and intended outcomes, determine internal and external issues, identify stakeholders and their requirements, and define the management system’s scope. The guidance shown on this page is relevant to the following standards:

ISO 9001:2015
ISO 14001:2015
OHSAS 18001:2007
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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 organization’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.

Demonstrating compliance

Look for evidence that your organization has undergone a process to initially identify these groups, and then to identify any of their requirements that are relevant to your organization’s management system. You should also determine whether these groups’ requirements are reviewed and updated as changes in their requirements occur, or when changes to your organization’s management system are planned.

More

4.1 Understanding Context
4.2 Interested Parties
4.4 Management System Processes
 

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