Planning of changes
Changed in ISO 9001:2026
Still numbered 6.3, confirmed in the published text. Same four considerations, plus three planned up front: communication of the change, how its effectiveness will be monitored and evaluated, and how the results will be reviewed — the loop closes.
Checked against the published text on 27 September 2026.
Plain-language summary
The clause is not new — 2015 already required QMS changes to be planned: purpose and consequences, system integrity, resources, responsibilities. The 2026 edition keeps all of that and closes the loop with three additions to what must be planned up front: how the change will be communicated to the people it affects, how its effectiveness will be monitored and evaluated, and how the results will be reviewed. 'We made the change' stops being the finish line; 'we confirmed it did what we intended' becomes the standard.
What the clause is really asking
Whether your change mechanism — change request, ECN, MOC form — thinks past implementation. Before the change starts, you decide how you will know it worked and who needs to be told; after it lands, you actually check and record the verdict.
What auditors look for
The end-to-end walk of a recent change is the test: planned or just happened? Right people informed? A defined way to judge success — and evidence the judgement was made? A change record that stops at 'implemented', with no effectiveness check and no dated review, is precisely the finding the new wording is designed to surface.
Typical evidence
Change records (FM-002-style) carrying three added fields with real content: communication (who was told, how), effectiveness check (the success measure defined before implementation), and a dated review of results. A sample of recent changes where all three are complete.
How to comply — recommendations
Extend the form you already have rather than creating a new one: add communication, effectiveness-check and review fields; make the effectiveness measure specific at planning time (scrap rate back under X%, changeover under Y minutes, zero customer escapes in 60 days); diarise the review; record the outcome even when — especially when — the change under-delivered.
Common nonconformities
Change records ending at implementation; effectiveness fields present but generic ('works fine'); affected shifts/departments never informed; changes reviewed only when they visibly failed.
Related clauses
ISO 9001:2026 — see also 6.1.1–6.1.3, 8.5.6, 7.2, 9.3
In the book
Chapter 6 — Planning — Risk, Opportunity and the Discipline of Change treats this clause family in full: what it is really asking, what auditors look for, the evidence that satisfies, how to make it work on a real floor, and where companies stumble.
Resources for this clause
- ArticleManagement of change grows teeth: the strengthened clause 6.3
- Toolkit · $99ISO 9001 Documentation ToolkitStop writing your QMS from a blank page: a fully-written quality manual, ten complete procedures and the working forms, logs and registers behind them — one numbering scheme, already cross-referenced, ready to adapt.
- Toolkit · $29ISO 9001:2026 Transition ToolkitTurn the 2026 changes into a working plan: gap checklist, clause-by-clause guidance and an action plan you can put in front of management.
- Free masterclass · ~15 minISO 9001:2026 MasterclassEvery ISO 9001:2026 change in plain English — climate context, quality culture & ethics, the risk/opportunity split, Annex A and the 3-year clock.
- Free course moduleInternal Auditor course — Auditing the New Ground: ISO 9001:2026 Audit Trails
- Course modulePractitioner course — Planning: Risks, Opportunities, Objectives & ChangeClauses 6.1–6.3
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