I
ISO 9001 Guy
I sent the following question to TC 176: "Does a QMS defined by an element-by-element approach meet the requirements of ISO 9001:2008, 4.1a?"If an user has to read ISO 9001 like "The Da Vinci Code", looking for subliminal nuances, in search of the holy grail, we are all doomed. There are (and we have discussed it here) questionable guidance from the IAF and the TC 176, especially a couple of "official" ISO 9001 interpretations. The IAF has developed Mandatory Documents as part of the Management System certification Conformity Assessment process. If they want something to happen consistently and be auditable, during the accreditation body oversight activities, a Mandatory Document is the proper channel; not a guidance document, which by definition, carries little weight in the eye of the registrants.
I don't know that it will receive a response. While some have expressed that the question is not appropriate, the IAF sectretary seems to think TC 176 will be happy to answer the question. So, we'll see. I hope it doesn't hurt to consider what implications the result of this "yes/no" would be.
If it does receive a response, and the response comes back, "yes," then the process approach will seem to remain just a good idea endorsed by the standard.
However, if the response to the question comes back, "no," then would THAT mean definitively that the element-by-element approach does NOT meet the requirements of ISO 9001:2008, 4.1a? If this turned out to be the case, and a CB contracted by an organization to assess conformity to ISO 9001:2008 is legally bound to assess conformity to the requirements of 4.1a, would an auditor working for a CB be lawful in considering a QMS defined by the element-by-element approach as being compliant to 4.1a? In other words, would we be talking about legal enforceability here? If THAT turned out to be the case, and I were a CB, I would be very interested in ensuring that all of my auditors were competent "particularly" with regard to the process approach, wouldn't you?
Pesky little details. (Or is it good risk analysis to ponder these things?)
Last edited by a moderator: