Competence

In plain words

For every activity that touches your quality, this clause demands four steps: determine what the person must be able to do. Ensure they can — through education, training or experience. Where something is missing, act (training, onboarding, supervision) and check whether the action worked. And: retain evidence — the competence records are mandatory documented information.

The word matters: competence, not certificate. What is meant is demonstrated ability, not collected course attestations. Twenty years of experience are a fully valid competence record — you just have to write them down. Conversely, an attended seminar proves no ability yet; that is why the clause explicitly asks for the effectiveness of the actions.

And the often-overread scope: it applies to everyone doing quality-relevant work under your control — employees, temporary workers, the permanent external contractor.

Why this requirement exists

Errors happen where ability is missing — and ability is missing most often where nobody ever consciously asked what an activity actually demands. “He can handle it” is the most expensive staffing decision in quality. The clause replaces chance with the conscious question — and makes the answer demonstrable.

The records also protect you: in a complaint or liability case (product liability), “who qualified this person for this inspection?” is one of the first questions. A maintained qualification overview answers it in a minute; without it, the question becomes a problem.

What good looks like

In a company of 12 people: a qualification overview on one page — people against the critical activities (setting up machines, first-article release, inspections, goods receipt), a date at each crossing: when signed off, by whom. Plus an onboarding plan per role with sign-offs (the buddy principle from 7.1.6 supplies the how), and a folder with the evidence: diplomas, training certificates, internal sign-offs.

The effectiveness check may be pragmatic: after onboarding, the first orders run under supervision, and the sign-off at the end is the effectiveness evaluation — no separate form needed. Good also means: the overview matches 5.3 — whoever may release per the role sheet has the evidence in the qualification overview.

What changes as you grow: From around 50 people, an annual training plan (derived from objectives and gaps) and competence matrices per process join. From 100–250 people, development paths, systematic needs analyses and role profiles emerge. The core remains: for every critical activity it is clear what it demands — and who demonstrably can do it.

The minimum to pass

• The requirements of the quality-relevant activities are determined — it is recognisable what one must be able to do to set up, inspect, release.
• Evidence exists and is findable — diplomas, trainings, documented experience, internal sign-offs; here the paper is mandatory.
• New people do not work unaccompanied on critical tasks — onboarding with a recognisable completion.
• The effectiveness idea is recognisable — after an action, someone checks whether it worked (supervision, sign-off, follow-up).
• External personnel are included where they work quality-relevantly.

What an auditor asks for

• The qualification overview — and the spot check: “Who may release first articles? Show me that person’s evidence.”
• The onboarding record of the newest person — plan, sign-offs, who accompanied.
• A training with an effectiveness trail: attended — and how did you notice it helped?
• The consistency with 5.3: do release authorities and qualifications match?
• For the temporary worker or contractor: who established their competence for the delegated task?

Common traps

• The certificate collection without reference. A binder full of course attestations, but nobody determined what the activities actually demand. Competence starts at the requirement, not at the course.
• “He’s been doing it for twenty years.” Probably true — but without any retained evidence it is a finding in the audit and a problem in a liability case. Experience counts fully; one dated line makes it evidence.
• Onboarding without sign-off. The new person “runs along”, nothing is retained. What is not evidenced did not happen in the audit — and the clause demands retention explicitly.
• Forgetting effectiveness. Training booked, attended, filed — whether it worked, nobody asks. The clause’s second half-sentence is its most overread.
• Attendance as an end in itself. Counting training days instead of checking ability. The standard does not ask how often someone sat in a seminar.
• The giant matrix. Fifty activities × everyone, never maintained. Critical activities suffice — the matrix must be right, not impressive.

Worked example

The qualification overview of Berger Präzisionsteile GmbH is one page: people against six critical activities — 5-axis setup, conventional setup, first-article inspection, series inspection, goods receipt, commissioning hardening — with sign-off date and initials. The evidence (trade certificates, Lea’s and Marco’s auditor course from the 9.2 chapter, internal sign-offs) sits in a folder with the personnel files.

The new machinist’s onboarding ran to plan with a buddy (the programme from the annual objective, 6.2): three months, defined stations, the first series under supervision — then Marco signed off series inspection. The finest effectiveness confirmation, though, was not in the plan: it was the moment the new machinist stopped the batch over a dimension doubt (the scene from 5.3). Whoever knows when to stop and ask has understood the onboarding — competence shows first in recognising one’s own limit.

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