ISO 9001 The Basics Explained: Clause 4.3 Scope of the Quality Management System

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What is the Scope?

The scope sets boundaries and applicability of your QMS and it is also included in the ISO 9001 certificate, so it’s very important to do and must be documented.

Try not to jump ahead with finalising your scope. Before defining your scope, you must take into consideration the following factors beforehand:

  • The external and internal issues that are relevant to the purpose of your organisation;
  • Your organisations strategic direction, and your ability to achieve intended results;
  • The requirements of relevant interested parties (internal and external);
  • The products and services of your organisation.

As the scope will available for all to see, in and outside of your organisation, you will likely want to keep it simple, short and easy to understand. It will help an auditor have a clear picture of your organisations purpose and activities, it will show you have considered your interested parties expressed needs and expectations, and it will ensure your organisation is aware of their involvement in the QMS.

How has this changed since the revision of the standard?

The 2008 standard referred to ‘exclusions’, unfortunately this was used in some cases as an excuse not to meet the standard in certain areas. Now however, the Appendix A5, specifically mentions that ‘exclusions’ are no longer referred to in the 2015 standard.

The revised standard focuses on ‘Applicability’. What’s applicable to your organisation depends on the organisation size, complexity, your practiced management model, range of organisational activities and nature of risk and opportunities it encounters. So your organisation can decide if a requirement from the ISO 9001:2015 Standard is applicable to the processes and activities in your organisation.

Remember that if you do decide a requirement isn’t applicable, you are responsible to ensure this doesn’t negatively impact your products and services.

The majority of organisations will apply the scope to their whole business, however you may have an organisation that has several different locations, so you may choose to only include one location in your scope. If you do, you will need to be very clear when defining what is applicable to the scope of your QMS.

Document requirements

The scope must be documented and maintained.



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