Planning of changes
Plain-language summary
Change the QMS deliberately, never by drift: consider why, what could go wrong, who needs resources and where responsibilities move — before the change, not after the chaos.
What the clause is really asking
When the QMS needs changing — new line, new system, restructure, new product family — plan it: purpose and consequences considered, QMS integrity protected, resources available, responsibilities reassigned. The clause is the antidote to 'we reorganised and quality fell over'.
What auditors look for
Auditors pick a recent significant change (new equipment, ERP swap, restructure) and ask for the planning evidence: impact assessment, who approved, how integrity was maintained, what happened to the displaced responsibilities. No paper trail = finding.
Typical evidence
Change requests/plans; impact assessments; management of change records; updated documents and matrices post-change.
How to comply — recommendations
A one-page management-of-change form (what, why, risks, affected documents/people/training, approval) used for every significant change gives you the whole clause. Tie it to your document control so updates cannot be skipped.
Common nonconformities
Major changes with zero planning evidence; responsibilities lost in restructures; documents and training lagging months behind the change.
Related clauses
IATF 16949: see also 8.5.6 production changes; ISO 14001 6.3-equiv planning; ISO 45001 8.1.3
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.
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