Design skills & embedded software (IATF only)
Plain-language summary
People doing design must be competent in the applicable tools and techniques; products with embedded software need a documented software quality assurance process with capability assessment.
What the clause is really asking
Organisations must ensure design personnel have the required skills (identified by the organisation) and master applicable tools. Where your product contains internally developed embedded software, a QA process for it must exist, with a software development capability self-assessment, and software development included in internal audit scope.
What auditors look for
Auditors check competence records of design staff against defined skill requirements (CAD, FMEA, DFM, specific toolsets). With embedded software: the development process, V-model or equivalent, capability assessment evidence, and audit coverage.
Typical evidence
Design competence matrix; tool training records; software QA process documents; capability self-assessments (e.g. Automotive SPICE-aligned); audit records covering software.
How to comply — recommendations
List the design tools your work genuinely needs and map people against them. If you have embedded software anywhere, even small controllers, stand up a basic documented dev process now — retrofitting under customer pressure is far more painful.
Common nonconformities
No defined design skill requirements; embedded software developed with zero documented process; software never audited internally.
Related clauses
Builds on ISO 9001 8.3.2 / 7.2
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.