ISO 9001:2015 4.3 - Determining the scope of the quality management system



Is it possible for an organisation to restrict the scope of the management system to certain functions?....for example

Design - Fabrication - Distribution - Installation.

Could the scope be limited to Fabrication and Distribution?

Sidney Vianna

Post Responsibly
Look at the last paragraph of 9001:2015 4.3. If your organization is responsible for product design and installation, you can not exclude such processes from the quality system and still claim compliance (much less achieve accredited certification) to ISO 9001.


Quite Involved in Discussions
If you are fabricating to a customer recipe / specification then product design is NOT APPLICABLE.


another perspective from a consultancy in the UK.....

"The scope of the QMS may include the whole of the organisation, specific and identified functions within the organisation, specific sections of the organisation, or one or more cross functions across a group of organisations."

This is clearly at odds with the "all in" approach

Sidney Vianna

Post Responsibly
You are obviously hunting for an answer that gives you the loophole you are looking for. So, if you are comfortable with the UK consultancy take, go with it.

If you "choose" to exclude product design and installation, are you willing to have such exclusions CLEARLY documented? ISO 9001:2015 mandates you do that. Are you comfortable with the idea of your customers reading that you don't have a quality system that includes product design and installation? They (the customers) might not appreciate that.

Organizations come in all sizes, shapes and degrees of complexity, so for a multinational organization, with multiple divisions, business units, sites all over the place they MUST be very careful when determining the boundaries of their respective systems.

And don't forget the fundamental distinction between scope of the system and scope of certification. When it comes to certification, yes, you can limit the scope of certification.


Trusted Information Resource
There used to be three standards in the ISO 9000 series that organizations could be certified to. ISO 9001 included all requirements, ISO 9002 excluded design & development, and ISO 9003 was for organizations that did inspection & testing. Many organizations saw ISO 9002 as a loophole where they could still get a "9000" certification without having to reign in all those design engineers who wanted to be creative but couldn't be bothered to follow standard processes.

When ISO 9001:2000 was published, the 9002 and 9003 versions were eliminated. I believe this was, in part, to ensure that organizations designing products and services included this function in their QMS. I still believe, like Sidney said above, that if you design product that you can't exclude it. How could you say that it doesn't affect your organization's "ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction" in good conscience? The same goes for installation.


Involved In Discussions
As your scope statement needs to include any clauses you wish to be exempted from and a clear justification for exemption. It is therefore up to you to determine what should and should not be included, especially with the design function.

Your auditor should be asking about exclusions and the justification for doing so and I am not sure I know any credible auditors, or customers for the matter, that would accept the design of the product being excluded from your scope.


Big Jim

Auditors are trained to look for evidence that you are a design company if you claim design nonapplicability.

For example, they should be looking at your web site as well as your literature to see if you say anything about design.

I have run into this, most usually on a stage 1 audit.

As a consultant, one of my clients added it to their web site after I was there, and it was caught by the CB auditor.

One auditee had been doing it for years, claiming it was OK because they sublet design, and put up quite a fight about it. Of curse, you cannot claim an exclusion for something you sublet.

So if you think you want to try it, proceed at your own risk, and the risk is high.
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