Issue 131 – What if your Quality Objectives don’t show improvement?
ISO 9001:2015…
What if your Quality Objectives don’t show improvement?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with ideas on what these publications should cover. In my last Newsletter (ISO 9001:2015 Newsletter Issue 130) we discussed the topic of “When is the next revision coming for the ISO 9001 Standard?”, and now in this Newsletter we will discuss “What if your Quality Objectives don’t show improvement?”.
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
What if your Quality Objectives don’t show improvement?… One of my Newsletter Readers recently got challenged by external auditors from two different ISO Registrars/Certification Bodies because their Quality Objectives were not showing improvement year over year. They managed to avoid an audit finding by saying there was no requirement in the Standard that said these metrics must improve, but their last auditor pushed back and said “continuous improvement” is required.
Although in principle I agree that the intent of establishing Quality Objectives would be to drive “continual improvement”… unfortunately the ISO 9001:2015 Standard does NOT specifically connect Quality Objectives to driving continual improvement, or for that matter that they must even be achieved… it simply asks you to set, or establish them, and then track these Quality Objectives to see how they are doing.
So how can you handle this situation?… As I have pointed out in previous Newsletters, I always suggest that you begin by politely asking the External Auditor to show you exactly which “shall” he or she says you are violating… and 9 times out of 10 they will back down when they realize that they are not sure which exact “shall” applies, and if they find one that’s close they will soon notice that the ISO wording is very vague/subjective AND open to interpretation… and you are allowed to have a different interpretation then the External Auditor!
If the External Auditor points to Clause 6.2 (Quality objectives and planning to achieve them) you will notice that there are two sub-clauses contained within it (6.2.1 & 6.2.2)… and none of the “shalls” mention continual improvement. If the External Auditor suggests that it is implied inside these words… you need to get more clarification by asking “What words in Clause 6.2 are you looking at that implies improvement?”… keep pushing back… because the actual wording doesn’t suggest or imply this at all.
If the External Auditor decides to point to OTHER Clauses then please realize that the words “continual improvement” or “continually improve” show up in only four (4) Clauses [4.4.1; 5.2; 7.1.1; 10.3] in the entire ISO 9001:2015 Standard. On a side note, only two of these Clauses require “documented information” [Clauses 4.4.1; 5.2]… which means you can address the others [Clauses 7.1.1; 10.3] verbally, without ANY written documentation. Within these other Clauses, the External Auditor is justifying that “improvement” needs to be demonstrated… and they are correct… however NONE of these Clauses [4.4.1; 5.2; 7.1.1; 10.3] have the words “Quality Objectives” within them.
What this means is that you simply need to show the External Auditor other examples of how you’ve “continually improved” your QMS… OTHER than using your Quality Objectives. It shouldn’t be hard to find examples… in fact any Opportunity for Improvement (OFI) identified during an internal audit is evidence of driving continual improvement… and even just developing a new Form could be offered up as an example of continual improvement.
If the External Auditor continues to persist with their wrong interpretation, then I recommend you say that you do NOT agree with them at the Closing Meeting (or sooner) and then appeal the audit finding to the External Auditor’s boss… and that always squashes it… why?… because they want to keep you as their Customer!
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…
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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.
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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.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!