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requirements; training records missing for people on critical operations; effectiveness never evaluated; matrix out of date after staff turnover.

Resources for this clause

• Toolkit · $99ISO 9001 Documentation ToolkitStop writing your QMS from a blank page: a fully-written quality manual, ten complete procedures and the working forms, logs and registers behind them — one numbering scheme, already cross-referenced, ready to adapt.
• Course modulePractitioner course — Resources, Competence, Awareness & CommunicationClauses 7.1–7.4