Competence
Plain-language summary
Make sure everyone whose work affects quality can actually do their job — define what competent means per role, check against it, close gaps, and prove it with records.
What the clause is really asking
Determine necessary competence for each quality-affecting role (education, training, experience), ensure people have it, take action where they do not (training, mentoring, reassignment), evaluate whether the action worked, and retain evidence.
What auditors look for
Auditors triangulate: the competence requirement for a role, the records of the person in it, and the person at the machine. The favourite catch: the new operator running a critical station with no training record, or training given with zero evidence of effectiveness evaluation.
Typical evidence
Competence matrix per role; training records; effectiveness evaluations (test, observation, sign-off); induction records.
How to comply — recommendations
One competence matrix: roles down, skills across, levels coded (trainee/competent/trainer). Define how effectiveness is checked — a supervisor sign-off after observed work is enough — and date it. Keep the matrix where supervisors actually plan shifts with it.
Common nonconformities
No defined competence requirements; training records missing for people on critical operations; effectiveness never evaluated; matrix out of date after staff turnover.
Related clauses
IATF 16949: extended by 7.2.1-7.2.4; ISO 45001 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.