Way back on the 4th February 2015, I wrote the final in our four-part series about upcoming changes to ISO 9001, ISO 14001 and ISO 45001; and recently (to put it bluntly) we had a complaint! Well, it was perhaps more an observation… that the article was misleading. Not the entire article, but this bit of it:
“Your certification body will likely expect your system to align with ISO 9001:2015.”
The complainant is of course correct. This statement is misleading. I should have written:
“Your certification body will require your system to meet the requirements of ISO 9001:2015.”
So why would someone get excited enough about this statement to bother to sit down and write me an email? It’s because it’s important, that’s why! Let me explain…
The word “align” suggests that the management system and ISO 9001:2015 are in the same order, that they are aligned, that the numbers in the organisation’s management system line up with the numbers of the clauses in ISO 9001:2015. This is not what ISO 9001 wants; in fact, if your management system does align with ISO 9001, it is almost certainly non-conforming. This brings us to examine what it is that ISO 9001 does actually want.
What ISO wants in your management system
ISO 9001 wants an organisation to adopt the process approach – and this requirement is very clear. In fact, the requirement is so important that it is mentioned many times (10 times actually!). And this is not new. The process approach has been in ISO 9001 since the 2000 version. Put simply, ISO 9001 wants an organisation to manage itself around its own processes, not in the way that the standard is organised.
Let me further explain the process approach, and from here on I will use the term ‘business’ rather than organisation to (hopefully) make things clearer.
For a business to operate both effectively and efficiently, it needs to do things (activities and processes) in the right order; and it needs to do them correctly. The activities and processes and the order and priority in which they are done will vary with each business; that is what makes a business unique and gives it a competitive advantage.
This is what the process approach is all about. ISO 9001 requires that:
“The organisation shall determine the processes needed for the QMS…and determine the sequence and interaction of these processes”.
So if your business is printing, your main processes may be:
As you can see, there are no processes here that align with ISO 9001 or even use ISO 9001 words, but it is how the business operates.
So if your consultant, auditor, or anyone else come to that, says that your system needs to align with ISO 9001, tell them they’re wrong. Your management system needs to reflect what your business does and align with that. It does not, and should not, align with ISO 9001 or any other standard.