Issue 127 – What Exclusions or NA’s can I take (Clause 4.3)?
ISO 9001:2015…
What Exclusions or NA’s can I take (Clause 4.3)?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications. In my last Newsletter (ISO 9001:2015 Newsletter Issue 126) we discussed the topic of “Who’s interested in Quality (Clause 4.2)?”, and now in this Newsletter we will discuss “What Exclusions or NA’s can I take (Clause 4.3)”.
The ISO 9001:2015 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Clause 4.3 Determining the Scope of the QMS – Allowable Exclusions?… One of my Clients recently got challenged by a group of External Auditors regarding taking an “NA” on Clause 8.5.5 (Post-delivery activities). They said that it was not an allowable Exclusion because only Clause 8.3 (Design and development of products and services) could be taken as an “NA”. As background information: a) this was a re-certification audit and this Lead Auditor had seen this same “NA” being taken in prior years; and b) this was the same ISO certification body they’ve used for over the past decade. When you are in disagreement with an auditor I always recommend politely asking: “So where in the ISO 9001:2015 Standard is this issue covered?”… followed by… “and what specific shall requirement are you looking at?”. .. and this is exactly what my Client did ask… and only got silence in response because there is nowhere that it states that only Clause 8.3 can be taken as an NA.
So what exactly does the Standard say?… Within Clause 4.3 (Determining the scope of the quality management system) you will find the shall requirements pertaining to this discussion. The following are the last two paragraphs from Clause 4.3: “The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.“. My Client went through each of the “shalls” found in Clause 8.5.5 Post-delivery activities and demonstrated how they were all either “Not Applicable”, or were already addressed in other areas of their QMS.
Faced with this dilemma, the External Auditors continued to argue their position by making reference to their certification body who audited them (ANAB) and that therefore this provided them with the justification for challenging this “NA”. My Client asked them where the ANAB requirements were located within the ISO 9001:2015 Standard since ISO 9001 is the ONLY criteria they are being certified to… once again silence from the External Auditors. Persistence paid off because in the end this was not identified as an audit finding in the Closing Meeting and the “NA” for Clause 8.5.5 was allowed to stand… as it should have been from the beginning. BTW, my Client was keeping me updated through emails in real-time so luckily I was able to provide some additional information that allowed them to push-back effectively and with confidence… and I was more than happy to quickly help out in time in order to avoid an unfair audit finding.
So why do auditors get into these interpretation problems?… In addition to the above situation, my Client was also confronted with a few more “challenges” from these External Auditors and each time my Client successfully pushed-back. Just to be clear, my Client was more than willing to accept any JUSTIFIABLE audit finding and was fully prepared to make adjustments/corrections to their QMS wherever it was needed. So how do auditors get into these situations? It’s simple really, auditors are just people too… we sometimes get used to interpreting the “shall” requirements in a certain way and when we are presented with something new or different than what we’ve experienced in the past, there can be a tendency to resist changing our thinking. As an auditor, if we have never been challenged before then we start to believe our view is the only view. When I’ve found myself in this same predicament, I stop and pause for a moment… then grab my copy of the Standard and check the exact wording to see if maybe, just maybe, my interpretation still holds water. My advice to any Auditee, don’t let any Auditor intimidate you… just keep asking for clarification on which SPECIFIC “shall” she or he is looking at in the Standard… and when they tell you which “shall” then it will come down to “interpretation” of the words… and by the way, you are allowed to interpret differently than what the auditor does!
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
To view all of our past Newsletters or to sign up to receive them… click here
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Need Help?
ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Internal Process Auditor Training for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!