D&D changes — supplemental (IATF only)
Plain-language summary
Every design change after product approval gets evaluated for impact, validated before implementation, and where required by the customer — approved by them first; embedded software changes are documented at both software and hardware level.
What the clause is really asking
Post-PPAP changes are the dangerous kind: assess impact on form/fit/function/performance/durability, validate against customer requirements before going live, obtain customer approval where their CSRs require it, and keep software revision documentation where applicable.
What auditors look for
Auditors cross-check change records against customer approval requirements in the CSRs, look for validation evidence dated BEFORE implementation, and for software-containing products check revision-level documentation.
Typical evidence
Change impact assessments; customer approval correspondence; pre-implementation validation records; software/hardware revision logs.
How to comply — recommendations
Add two gates to your ECN flow for post-approval changes: 'customer approval required? (check CSR)' and 'validation complete?'. Neither gate passable by deadline pressure.
Common nonconformities
Changes shipped before customer approval the CSR requires; validation after implementation; software revision undocumented.
Related clauses
Builds on ISO 9001 8.3.6; links IATF 8.3.4.4, 4.3.2
In the book
Chapter 8 — Operation — Where the Product Is Won or Lost 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. This IATF requirement is covered in the Automotive Edition, in the same six blocks as the ISO clause around it.
Get the free ISO 9001:2026 Readiness Scorecard
Free, instant download. We'll only email you the occasional practical quality update — no spam, unsubscribe anytime.
Qlause provides interpretive guidance only and is not a substitute for the standard. Refer to your licensed copy of the relevant standard for the authoritative text.