Control of changes
Plain-language summary
Production changes — planned or forced — get reviewed and controlled so conformity survives, with records of the review, who authorised, and what actions followed.
What the clause is really asking
Review and control changes for production/service provision to the extent necessary for continuing conformity. Retain documented information on change reviews, authorising persons and resulting actions.
What auditors look for
Auditors hunt the undocumented change: a different machine, an alternative material, a new supplier lot setting — then ask for the review and authorisation behind it. Emergency changes (the Friday-night workaround) are the favourite quarry.
Typical evidence
Process change records; review/authorisation evidence; trial results before full implementation; document updates following changes.
How to comply — recommendations
One process change form, used even under pressure: what changed, why, risk check, trial/verification, approval, documents touched. Make the emergency path explicit — a fast form beats no form.
Common nonconformities
Workarounds becoming permanent without review; changes authorised verbally; control plan never updated after the change everyone knows about.
Related clauses
IATF 16949: extended by 8.5.6.1 + 8.5.6.1.1; links 8.3.6
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of ISO 9001 / IATF 16949 for the authoritative text.