I have had ISO 9001:2015 FDIS now for a couple of days, and I am busy trying to reconcile a few discussions I have seen about the FDIS, Annex SL and also what I would describe as a few myths. The subject of “exclusions” is something, at this present moment in time, I am ready to put on the latter pile.
Does ISO 9001:2015 FDIS permit exclusions in the same way as ISO 9001:2008?
Based on my interpretation, I would say that this is more “yes” than “no”. Initially 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.
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 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 FDIS 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.
So, to summarise, in my opinion, we are pretty much where we were. So panic over.