This one is easy to miss, because the clause is not new. Clause 6.3, "planning of changes", has been in ISO 9001 since 2015. What the 2026 draft does is strengthen it — and the additions change how an auditor will test whether your change management actually works.
What 2015 already asked
The existing clause is short. When you change your quality management system, you plan the change deliberately rather than on the fly: its purpose and potential consequences, the impact on the integrity of the QMS, the resources you will need, and how responsibilities and authorities are allocated or reallocated. Good systems already do this through an engineering-change note, a management-of-change form, or a documented change request.
What 2026 adds
The 2026 draft keeps all of that and extends what you have to plan for up front. Alongside the existing considerations, the planning of a change is expected to address three further points: how the change will be communicated to the people it affects; how the effectiveness of the change will be monitored and evaluated; and how the results of the change will be reviewed.
Read those together and the intent is clear. The clause is closing the loop. It is no longer enough to plan and make a change — you are now expected to decide, before you start, how you will know it worked, and then to actually check.
Why it matters
"We made the change" stops being the finish line. "We confirmed the change did what we intended" becomes the standard.
In most organisations, change planning is the strong half and change verification is the weak half. A line gets modified, a supplier gets switched, a procedure gets revised — and the record stops at "done". The 2026 wording targets exactly that gap. It is a small documentation change with a useful discipline behind it: changes that are never reviewed are how quiet problems get introduced.
What an auditor will look for
Expect the auditor to pick a recent change and walk it end to end. Was it planned, or did it just happen? Were the right people told? Was there a defined way to judge whether it succeeded — and is there evidence that judgement was made? A change record that ends at implementation, with no effectiveness check and no review, is the finding this clause is designed to surface.
What to do now
- Find your existing change mechanism — change request, ECN, MOC form, or the change section of your management review.
- Add two fields if they are missing: a short effectiveness check (how you will confirm the change worked) and a review step (the outcome, dated).
- Add a line on communication — who was informed, and how — so that part is visible too.
- Sample a few recent changes and ask honestly: could you show an auditor that each one was reviewed for effect? If not, that is where to tighten.
None of this needs new software or a new procedure — it is a small extension to a record you almost certainly already keep. We map the new 6.3 sub-points to the clause text in the clause explorer, and this is a routine part of the gap assessments we run. Talk to us if you would like your change-management process checked before the transition.
Based on the 2026 final draft; the exact sub-point lettering and wording of clause 6.3 may be confirmed differently at publication.