Design & development — general & planning
In ISO 9001:2026
Checked — unchanged; a new note allows for iterative cycles of review, verification and validation.
Plain-language summary
If you design products (or under IATF, processes), do it as a managed project: defined stages, reviews, verification and validation activities, clear responsibilities, the right people, and records throughout.
What the clause is really asking
Establish a D&D process and plan each project: nature/duration/complexity, stages and reviews needed, verification and validation, responsibilities, internal/external resources, interfaces, customer involvement, documentation needed.
What auditors look for
Auditors pick a project and check the plan against execution: milestones, review records, who owned what, customer involvement evidence. Where design is excluded from scope, they verify the exclusion is genuine — process design under IATF can never be excluded.
Typical evidence
D&D project plans; stage gates; review minutes; responsibility matrices.
How to comply — recommendations
A simple stage-gate template (concept-design-verify-validate-launch) with a review record at each gate covers planning for an SME. Keep customer touchpoints visible in the plan.
Common nonconformities
Projects run informally with no plan; gates skipped under deadline pressure with no recorded decision; responsibilities assumed, not assigned.
Related clauses
IATF 16949: extended by 8.3.1.1, 8.3.2.1-8.3.2.3 (process design ALWAYS applies)
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.
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