Design & development outputs
Carried over from ISO 9001:2015
Checked — unchanged.
Checked against the published text on 27 September 2026.
Plain-language summary
Design outputs must let the rest of the business succeed: meeting input requirements, adequate for production and service, including monitoring/measuring needs and acceptance criteria, and stating what is essential for safe, proper use.
What the clause is really asking
Outputs (drawings, specs, BOMs, instructions) verified against inputs, sufficient for purchasing/production/service, referencing acceptance criteria and product characteristics essential to intended purpose and safe provision. Records retained.
What auditors look for
Auditors check output completeness for a sampled product: can production actually build from this? Acceptance criteria defined? Safety-essential characteristics specified? Output-to-input verification recorded?
Typical evidence
Released drawings and specifications; BOMs; acceptance criteria documents; verification records.
How to comply — recommendations
Use a release checklist: every output document listed, verified against inputs, approved. Outputs are done when production and quality can work from them without phoning the designer.
Common nonconformities
Drawings released without tolerances or acceptance criteria; production discovering missing information at first build; no record outputs were checked against inputs.
Related clauses
IATF 16949: extended by 8.3.5.1, 8.3.5.2
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.
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