ISO 9001:2015 Exclusions to Scope


Does ISO 9001:2015 FDIS permit exclusions in the same way as ISO 9001:2008?

The simple answer to that question is “yes”. Initially, before the FDIS was issued, I was concerned that the rumours of “no permissible exclusions” were going to be true – and many people are still maintaining that it is true, but I don’t think it is. They are, by the way, now known as “non-applicable” clauses, rather than exclusions.

In ISO 9001:2008, the statement relating to permissible exclusions is defined with clause 1.2 Application of Scope. It is quite clear. Exclusions are permitted, they are limited to clause 7, must be justified and can only apply where the requirement doesn’t affect the company’s ability to meet its output requirements (I’ve paraphrased). Therefore, when I received my copy of the FDIS of ISO 9001:2015 I went straight to section 1 (Scope) to see if there was an equivalent statement – there wasn’t. Quite the reverse in fact, instead there was the following statement

“All the requirements of this international standard are generic and are intended to be applicable to any organisation, regardless of its type or size, products or services”

Nothing about exclusions. So what about clause 8.3 Design and Development? This clause is pretty similar to clause 7.3 of ISO 9001:2008 – no major changes – what about a company that has no design function? A warehouse for example? Surely a company that has no design function wouldn’t be forced to develop contrived “design” procedures for the purpose of ticking a box? It was my understanding that ISO 9001:2015 was looking to move further away from that approach?

After a while my concerns were alleviated, however. Whilst the clarification regarding applicability (or exclusions) is not defined in Section 1 (Scope), it is defined somewhere else, and when you read it carefully it leaves us not too far away from where ISO 9001:2008 is on the matter. My assumption is that those people who maintain the position of “no exclusions in ISO 9001:2015 FDIS” have simply checked Section 1 (Scope) and nowhere else.

Context of the Organisation

The guidance relating to applicability of requirements ( and non-applicability, exclusions in other words) has moved. It is no longer mentioned in the Scope. It is outlined in Section 4.3 Determining the Scope of the Quality Management System. In that section we receive the following advice;

“The organisation shall apply all the requirements of this international standard if they are applicable within the determined scope of the quality management system …. and provide justification for any requirement of this international standard that the organisation determines is not applicable to the scope of its quality management system”

Now that, I would argue, is pretty close to where we were on the topic of exclusions in ISO 9001:2008. The matter of applicability is addressed (i.e. not all requirements will be applicable to every organisation) and where a requirement is not applicable, it has to be consistent with the defined scope and justified by the organisation. The only material differences, so far as I can tell, is that the requirement has moved and the actual word “exclusions” is no longer used.


One thing that has changed, however, is the limitation of non-applicable clauses to a particular section of the standard (in ISO 9001:2008 that is section 7). That means, in theory, an organisation can cite a non-applicable clause from any part of the standard, provided it can be justified. In practice, that’s not going to happen. To a large extent the more common exclusions from ISO 9001:2008 (design, preservation, customer property) map across on to clauses in section 8 of ISO 9001:2015, but we need to be careful. There are a couple of obvious clauses that fall outside of section 8 that will be justifiably excluded by many. The Calibration and Measurement Traceability requirements in Section 7 of ISO 9001:2015 are the most obvious.

So, to summarise, in my opinion, we are pretty much where we were. So panic over.

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8 Responses to ISO 9001:2015 Exclusions to Scope

  1. Jim MacLellan says:

    Hi Shaun,
    I’m pretty sure that wording was in the DIS version.
    As far as design is concerned, then even a warehouse evolves and; operationally; there are elements of design, I think:
    * job design: to ensure that safety risks are kept to a minimum;
    * layout design – to ensure that longitudinal and lateral travel distances are optimised;
    etc., etc.
    So, for me, there really should never be n/a’s or exclusions, if one is truly sincere about the standard. I’m not saying you are not sincere in your approach – far from it. But, too often, I think that people do not try to use the standard for absolutely everything that they do in business. In fact, given the FDIS wording, I would now question why one needs ISO 14000 or any future 18000 series, as I think that 9001 deals with it all.
    Keep up the great work, Shaun!
    Kind regards, Jim MacLellan

  2. Shaun says:

    Thanks for taking the time to read and comment, Jim, I appreciate it.

    I don’t subscribe to that school of thought so far as “design” goes, Jim. A warehouse, unless it develops some innovative storage solution that utilises fresh concepts, does not “design” anything. Stuff comes in, certainly it has to decide where to put it, whether things need humidity/pest control etc, but that is planning in my book. Moreover, remember as soon as you declare something “design” you have to go through the whole none yards of design planning, inputs, outputs, verification and validation. Also, if a customer physically hands you the design and says “make that” you don’t do the design. I suppose you could argue that you need to “design” how you will fabricate the “design” but in that case, what is planning?

    I also don’t agree that ISO 9001 is a sufficiently descriptive standard to apply to an EMS or an OHSMS. What you are suggesting there (if I read you correctly) is that 9001 is now a functional and fit for purpose IMS standard. I don’t agree with that, I’m afraid.

    Thanks once again for the read, comment, words of encouragement and the challenge. It’s all welcome.


  3. Shankar Pillay says:

    Dear Mr.Shaun-
    The point of design and development is also required for manufacturing process if not for product. Therefore, I think it will be very dice to skip this clause.
    kindly give your thoughts on the same..
    Shankar Pillay
    QMS-Lead Auditor[IRCA]

  4. Shaun says:

    Thanks for taking an interest in the post, Shankar.

    I don’t see excluding design as dicey in any way. Excluding design isn’t a dodge or a short-cut, it is a factual state of affairs. If the company does not perform any design, then the requirements of a design process don’t apply to it. I take the view that if a company has no design activity, then if the certificate DOES NOT exclude design, then it is a mis-representation. In a worst case scenario that would enable a company to claim certified competence in a discipline that it does not. That is, if they have no design function or competence, the certificate SHOULD NOT suggest that they do.


  5. Muralidhar says:

    Great work Shaun. good indepth reading by you. It has enlightened me.

  6. Tomaž says:

    Quite simple approach to understanding design – it is something that is finishing in pricelist. Al other acivities are improvements, measures, …

  7. Yasser Estafanous says:

    my products are manufactured by another company but I make the manufacturing control on every stage ,
    what i can exclude from the ISO 9001 -2015 ?

  8. Shaun says:

    Unfortunately I couldn’t say with such limited detail. It really depends on what your processes actually involve.


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