ISO 9001 2026 DIS Clause 6 Updates: Where did Opportunities go? This and New requirements for MOC.
By ISO & API Mastery with Miriam
Summary
Topics Covered
- Separate Opportunities Clause Forces Proactive Planning
- Process-Level Objectives Align with Best Practices
- Mandatory Change Effectiveness Evaluation Preserves Integrity
Full Transcript
Hello everyone, welcome back to our comparison review of the ISO 9001-2026 DIS vs ISO 9001-2015.
We know you want to understand what is new and different in this document, but you may not have time to go through the DIS line by line. That is
exactly what I am doing this review for you. Clause 6, which focuses on planning, is one of the sections where there's a lot of things that are very similar, but some changes are important enough that it's worth checking them out.
So let's get started with sub clause 6.1, Actions to address risk and opportunities. One small but noticeable change is the reordering.
and opportunities. One small but noticeable change is the reordering.
For example, the 6.1.1 requirement for risk and opportunities to enhance desirable effects was moved down without any modifications. A similar move happened on 6.2.1 regarding relevancy of the objectives, where the requirement was also moved down.
Another subtle change is the use of the term continual improvement, consistent with what we saw in Clause 5 already. For example, the 6.1.1d requirement to address risks and opportunities to achieve continual improvement reinforces that improvement is ongoing, not a one-time thing.
The more relevant change in my view is that ISO now separates risk and opportunities into two distinctive sub-clause. We
saw that opportunities was extracted from 6.1.2 and made into its own sub-clause 6.1.3. This will
force your company to plan opportunities rather than just hide behind the risk. This is big in my view and reinforces that although ISO did away with preventive actions, which was a bit misunderstood, the concept of having opportunities will hopefully be
better understood this time around. This is to me a great move because when you combine requirements, Although it makes a standard more succinct, the problem is that if one of the elements of the requirements is misunderstood, then it can be downplayed or like we mentioned before, it's like
one can hide behind the other. And there could be misunderstanding both by the auditor or by your own company. So by having it in its own clause, Now you are forced to deal with it. You can't just not do it. You could say, well, we don't really have any opportunities, or
do it. You could say, well, we don't really have any opportunities, or last year we did not have any opportunities. Just like you could have said in the past, oh, we didn't have any preventive actions. But here is the thing.
How do you prove you are complying with this requirement on the standard? By not
having any other requirement to hide behind, you are forced to demonstrate compliance. So even if you did not have any preventive actions like in the
compliance. So even if you did not have any preventive actions like in the past, I will tell people, well, you're gonna have to come up with an example and you're gonna have to go through your entire process to demonstrate that should you have one, you will know what to do. Well, the same thing happens here. If
you could say, oh, well, I don't have any opportunities, well, still you have to demonstrate how will you handle an opportunity? What is the process to address opportunity? This is something that we're definitely going to be updating on our
address opportunity? This is something that we're definitely going to be updating on our courses at Miro University so we can explain this better to our students.
Good news for WebQMS users is that we already consider opportunities very important and we have it as part of the risk and also we consider opportunities within our Continual Improvement Program or CIP application. But in
reality, all WebQMS applications have an element of opportunities handled via actions as opposed to corrective actions. Alright,
continuing on this subclause, ISO has also repurposed the nodes so that examples of opportunities clearly support the opportunity requirements. Moving along to subclause 6.2, quality objectives,
requirements. Moving along to subclause 6.2, quality objectives, and planning to achieve them. Another small, but in my view, a great change is that quality objectives must now be established at the process level. If
you are a client of ours or a company that we help get certified, then you're in luck. because for us, establishing objectives by process has always been key.
In fact, in the Objectives app within our WebQMS software, we already make it a point to list objectives by process. Now, you can do objectives by department or objectives just by location, but the process field is already available. The requirement to maintain documented information
was repurposed as a new bullet, so it should be easier to implement and audit. Okay, so moving right along to sub clause 6.3, planning
audit. Okay, so moving right along to sub clause 6.3, planning of changes. Before we get into the big change, let me tell you about a
of changes. Before we get into the big change, let me tell you about a tiny modification from change to changes making it clear that this applies broadly not just to one change sometimes this is important because you can have people that really want to go by the letter of the law and
it is really hard to explain to them that this may mean something else.
The most relevant change, which I believe has a big impact for companies who were doing the bare minimum, is that organizations are now explicitly required to monitor and evaluate the effectiveness of changes, communicate the changes, and review the results of changes. Woohoo! Yay!
I am so happy for our consulting clients and our WebQMS subscribers.
See, we always need management of change the right way. I mean,
even when ISO was asking for the bare minimum, just like in risk assessment, we always use best practices, known and proven protocols, rather than just shallow systems that could fail any time when they were poked or that really didn't add any value to the company. Well, good processes always paid off. So
I'm glad to see this requirement. If you have implemented or want to implement ISO for the right reasons, then this requirement should not scare you. In fact, you really need to do a good job when you have changes, not just for ISO sake, but for the sake of your own management system, right? You wanna make sure that
Things that are being done correctly stay even when there are changes. So you
should not really take this as a hard to implement requirement or as a burden, but rather welcome it as a good process to preserve the integrity of your management system.
In summary, clause six includes clearer separation of risk and opportunities, stronger expectations around change management, and better alignment with the process approach. Well, we continue to actively review the ISO 9001-2026 DIS or Draft
International Standard and we're documenting our observations, wording changes, and interpretation changes. as the draft evolves. If you
would like to receive a copy of our comparison analysis, sign up and we will send you each section as we complete it. Thank you for watching and if you're interested to know more about what changes are coming up in the ISO 9001-2026 DIS, be sure to watch the previous comparison of clause 5 or
our next comparison of clause 7. Thank you and see you in the next video.
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