ISO 9001: Determining The Scope Of The QMS

In this series of blog posts, I will be taking a look at the main sections of ISO 9001, what they are, why they are important ...

So, firstly, what does 'Scope of the Quality Management System (QMS)' mean? Well, it's the boundaries of your QMS. This can be physical boundaries such as it applies to the UK branch, but not the USA branch. It can also be departmental boundaries such as the QMS applies to Production, but not to your centralised HR department.

"Your scope can also be defined down to a specific product or service that you provide!"

I would query why you would not want the scope to cover the whole of your organisation unless you are very large and have very clear divisions. After all, surely the whole of your organisation should be working to processes and all affect customer satisfaction?

One of the main questions I hear is, "Some sections of ISO9001 don't apply to me, can I take these out of scope?" The answer is yes, you can take them out of scope. An example is 7.1.5.2 Measurement Traceability. For many service-based organisations, they have no equipment that requires calibration, so they exclude that section from the scope of the QMS.

There is some debate as to whether Section 8.3 Design and Development can be considered 'not applicable' to many organisations. Taken literally, every organisation designs and develops its products or services to provide the customer with satisfaction.

However, in practice, many organisations that do not literally design a product, do exclude design and development from the scope. I have personally had external auditors accept both approaches, whilst others give 'non-conformance' for excluding it; I have yet to have a firm answer as to whether section 8.3 can be excluded or not!

Why is this important? Well, if you do not know the scope of your business, you do not know where your level of control starts and finishes. It is useful to determine exactly what your QMS covers and what it does not.

You need to document this scope information. This can be in a Quality Manual, on your website, on the office wall. It doesn't matter how, just as long as it is documented. Your scope will form part of your certificate, so needs to be defined as it will be written on there by your certification body.


If you would like to know more about anything I've mentioned in this blog post, do give me a call on 01858 414226 or leave a comment below and let's see how I can help you.