Design & development changes
Plain-language summary
Once designed, change carefully: identify and review every change, control it to prevent harm to conformity, and record changes, reviews, authorisations and actions.
What the clause is really asking
Changes during or after design get identified, reviewed and controlled so they do not adversely affect conformity. Records retained of the changes, the review results, who authorised, and actions taken.
What auditors look for
Auditors sample design changes: review evidence before implementation, authorisation, impact on related documents (FMEA, control plan, instructions) and on already-produced/fielded product.
Typical evidence
Engineering change records; impact assessments; authorisation evidence; document update trails.
How to comply — recommendations
One ECN form: what changes, why, impact (documents/tooling/stock/customer), approvals. No change without the form — including 'small' ones; small changes cause big recalls.
Common nonconformities
Changes implemented before review; affected documents updated late or never; impact on existing stock not considered.
Related clauses
IATF 16949: extended by 8.3.6.1; links 8.5.6
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.