ISO 9001:2015 Non-Applicability

Non-applicable clauses and how to treat them

I’m starting to get asked this a lot just now, so maybe it’s time for an article to explain it, and to point people at. Those people going through ISO 9001 transition now, and whose QMS identifies some clause(s) that ISO 9001:2008 calls “exclusions”, will need to revisit the matter.

In many ways the same rules apply, but there are a couple of differences.

Firstly, whereas in ISO 9001:2008, “exclusions” were limited to Section 7 (Product Realisation), ISO 9001:2015, on the face of it, applies no such constraints so, in theory at least, non-applicability (the new name for exclusions) may be identified within ANY of the new auditable requirements of Sections 4-10. In practice, however, you will find that your realistic non-applicable clauses (that is, clauses that certain types of organisations may justifiably explain are not applicable to its operations) will be limited to parts of ISO 9001:2015 sections 7 and (mostly) 8 (which is, to all intents and purposes, the equivalent of the old Section 7).

It is unlikely that any requirements of Sections 4, 5, 6, 9 or 10 could be justifiably cited as not applicable. I’d be amazed if any were accepted under any circumstances.

So what could be cited as not applicable?

There aren’t that many potentially non-applicable clauses. In Section 7 (Support), in practice you are looking at clause 7.1.5 – this relates to monitoring and measurement resources and measurement traceability. This clause deals with the EQUIPMENT that may be used in monitoring and measurement (not monitoring and measurement activity) and includes the old calibration and equipment care requirements. Not all organisations use equipment in their monitoring and measurement activities, and it will be a fairly common non-applicable clause, especially with service providers. Measurement traceability (note NOT Product Identification & Tracebility – this is different and taken care of within Section 8) is not always a requirement, and in fact the wording of the clause in ISO 9001:2015 actually states “where measurement traceability is a requirement …”. Measurement tracebility will normally, if it applies, be required either by legislation or by the customer contract.

In Section 8 (Operation) there are a few potentially non-applicable requirements, because it contains all the old favourites from ISO 9001:2008. Most notably;

  • 8.3 Design and development
  • 8.5.2 Identification & Tracebility (of product)
  • 8.5.4 Preservation
  • 8.5.5 Post delivery activities

In practice pretty much close to 100% of any other non-applicable claims will be drawn from the above and Clause 7.1.5. Note that in days gone by “Customer Property” used to be a reasonably common exclusion under ISO 9001:2008/ISO 9001:2000, however as this clause (ISO 9001:2015 clause 8.5.3) covers intellectual property and data, it is rarely justifiable these days. Most companies hold some customer data that requires protection –  financial/payment/bank data at the very least.

How to record non-applicable clauses

If you deem that a clause or clauses is/are not applicable to your QMS (for example it simply does not contain a design element, or you have no physical output that can be spoiled or damaged and so requires preservation controls), these must be identified and JUSTIFIED in the statement of SCOPE (see clause 4.3) of your QMS. In justifying the non-applicable clause, you are simply explaining (and making it clear) why this does not apply to any of the contents, controls or customer requirements of your QMS.

Hope this helps.

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2 Responses to ISO 9001:2015 Non-Applicability

  1. Mallya KK says:

    For Design centres performing design & development and testing of embedded software, The remaining clauses of
    8.4 to 8.7 can be excluded as there is no further service activities

    Pl let us know your comment

  2. Shaun says:

    No, that is unlikely to be correct. Clause 8.5.1 (Process Control) is a difficult one to justify citing as not applicable. The design house may well use suppliers and subcontractors, or occupy premises provided by a landlord, which would make clause 8.4 applicable to it. They would also need traceability on their design projects, and also to have sign off and release activities. There may well be a couple of non-applicable clauses if, say, they held no customer property or provided no post delivery activities, which are both feasible, and, as the designs are effectively IP, preservation would not apply, but to suggest they’d be able to excluse clause 8.4 through to 8.7 in their entirety would be implausible.

    Thanks for taking the time to read and comment.

    Shaun

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