In this article, I am going to review the requirements of Clause 4.3 Determining the scope of the quality management system. I am going to break it down and turn it into something we can all understand.
You will then be able to apply this to your own organization's system and understand what the requirements will look like for you.
No more guessing!
Clause 4.3 is called Determining the scope of the quality management system. There are a few points in this clause, so I am going to break them down and explain them bit by bit.
The first point, in the leading sentence, is
The organization shall determine the boundaries and applicability of the quality management system to establish its scope
The words that stand out to me here are boundaries and applicability. It’s almost like putting a fence around the system so we know what activities, products, services, and even locations are included in the management system.
Now there’s some more information that we are asked to consider when determining these boundaries and applicability.
The next section states that:
When determining this scope, the organization shall consider
a) the external and internal issues referred to in 4.1
b) the requirements of relevant interested parties referred to in 4.2
A quick reminder that clause 4.1 is Understanding the organization and its context and 4.2 is Understanding the needs and expectations of interested parties. The reference back to these previous clauses is great – I love it – it shows how everything that we do within this standard is all related. Nothing that we do is just a standalone step created just to keep auditors happy and cause frustrations to businesses implementing the system. What you discover about your business in the steps followed for clauses 4.1 and 4.2 will influence the boundaries you determine for your management system.
For example, if it was identified that contractors have an influence on the quality management system as a large part of work is completed by contractors and the work performed is vital to meet contract requirements, then it would be necessary to ensure that those activities are included in the scope, which essentially goes back to the boundaries and applicability. It would have an adverse effect on the system if these activities were not included within the scope as the management system would not be implemented or reviewed to include this vital scope of work.
And then there is
c) the products and services of the organization should also be determined for the scope.
This is a great point and it is emphasized again shortly when we are asked to document the scope – so hold that thought!
As we move through this clause further it states that:
The organization shall apply all the requirements of this International Standard IF they are applicable within the determined scope of its quality management system.
Interesting ….. This is a unique element in ISO 9001. ISO 14001 or ISO 45001 do not allow for areas to be identified as not applicable to the system – this is just ISO 9001. To explain this requirement of applicability further I can use a training provider as an example – even Auditor Training Online to make it more relevant. If Auditor Training Online purchased off-the-shelf courses and then just delivered them, we could state in our scope that Clause 8.3 Design and Development was not applicable to our quality management system.
However, we do design and develop our own courses so in the ‘real world’ we could not state this.
Design and Development is a common clause that is stated as not applicable as in some businesses they do just purchase and then re-sell and there is no design or development involved.
Another common clause is clause 7.1.5.2 Measurement traceability, which is essentially equipment calibration. If the business does not have any equipment that is used for products or services to customers that require calibration, then this clause could be stated as Not Applicable.
I do hope those examples have explained this further – if you are uncertain of any areas of applicability for your own system, please comment below and I can help.
Clause 4.3 goes on to say
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.
Excellent – that’s great for us as auditors, as we are expecting to see a scope written down somewhere and identify what has been determined as not applicable - so it is clear what we are using to select our sampling from. And as Implementers of a system be sure to have this documented! Now that we are speaking of documented scopes, you still might be wondering what on earth this looks like. Lucky for you, I’ve found a few examples for you………. These are from organizations that I have audited over the years.
Electrical and mechanical consulting engineers providing engineering design and documentation for mechanical and electrical installations associated with all types of buildings of residential, commercial, or industrial nature in Australia and overseas
And this example includes a part of the standard that is not applicable so you can see how this is documented too ………
The importation, distribution, supply, service, and repair of industrial products and other products as deemed necessary to satisfy our customers’ needs and requirements. Clause 8.3 Design and Development is not applicable as this activity is not part of the service and products we require.
Now, the last sentence of this clause is really important and wraps all of this up for you.
It states:
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
Interesting right? This means you can’t just state that a section of the standard is not applicable because it is easier or cheaper to leave it out of the scope. Justification has to be valid. If you leave out a requirement and it impacts customer requirements and satisfaction then it will be an issue, for both your business, your system, and your conformance. So, please take this seriously and include all requirements that are relevant and applicable.
I know that this can be confusing sometimes and isn’t always as straightforward as the examples I have given. This is why I want you to comment below and ask the question. I want to help you to sort this out.
If you are looking for more information or want to join the best profession out there, head over to our website and enrol in one of our ISO 9001 courses today!