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Quality Management System Scope

ISO 9001:2015 Clause 4.3 defines the requirements of the organization’s scope. The standard states that the quality management system needs to have a defined scope, which specifies its boundaries and applicability. The scope will be referenced on your ISO certificate as it states what parts of your business are within or excluded from certification. The scope will assist your registrar in knowing what areas to audit and in estimating audit time.

You are only required to state within your scope the types of products and services covered and justification for any requirement that is not applicable to the scope of the quality management system. For example, if your organization does not design or develop any of its products or services then you would want to state the exclusion of this section of the ISO 9001 standard within your scope.

If you have more than one facility, you will want to list any of those locations that are within or excluded from the scope of your quality management system.

When determining scope, you will also want to consider external and internal issues, requirements of relevant interested parties, and the products and services of your organization.

For example, if you are a manufacturer of toys, the scope of your QMS may be:
The scope of the Quality Management System includes the major product and service categories associated with the primary functions of manufacturing wooden toys at the North Pole location and distributing the product to children of all ages.


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