Issue 104 – How do I comply with an ISO requirement?
ISO 9001:2015…
How do I comply with an ISO requirement?
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 103) we discussed the topic of “Customer Complaints: Open your ears!”, and now in this Newsletter we will discuss “How do I comply with an ISO requirement?”.
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
How do I comply with an ISO requirement?… I’ll begin by relating a recent audit interview that prompted my choice of this topic for the Newsletter. I was having a discussion/interview with a senior person regarding where to draw the line when trying to comply with an ISO 9001 requirement. He had obvious strong analytical skills which was causing his frustration in trying to do the right thing from a ‘quality’ perspective but without creating a mountain of non-value added work to his already busy day. He wanted some advice and direction on where ISO applies (and where it did not), within the processes he was responsible for, and he was being totally sincere in his request. One part of the problem was that he inherited documented procedures that were written at least two decades earlier (and subsequently revised multiple times), as part of the original push to get the initial ISO 9001 certification for the organization. The other part of his dilemma was that he never received any formal education/training on what the underlying intent is of ISO 9001.
So what’s the answer?… What I have found over many years of working with companies in applying the ISO 9001 requirements, is that it is always better to FIRST understand how you need to run your business to keep your Customers happy, and THEN decide how to make ISO 9001 comply with your approach. The ISO 9001:2015 Standard is written in a non-prescriptive way to allow exactly that to happen. Many of my Clients have heard me say this before: “Just tell me how you do this activity (in order to run your business)… and we will find a way to make it meet the Standard”. In the situation that I described above, I simply asked him to forget about ISO for a minute and to then describe to me how he currently managed his processes to ensure ‘quality’ product was being made every day. When he was finished, I told him that’s what he needed to say inside his Procedures, and then make sure his people were doing it that way, every day… and he would have no problems complying with the ISO 9001 requirements. Taking this approach made more sense to him since he definitely knew what needed to be done to run the business, which eliminated the question of where to draw the line as to where ISO applied and where it did not. Everyone calls it a “Quality” Management System (QMS) but it’s easier to think of it as a “Business” Management System!
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!