ISO/IEC 17025 clause 6.2: demonstrate personnel competence

What clause 6.2 requires in practice

Clause 6.2 has six provisions on people. Everyone who could influence laboratory activities, internal or external, must act impartially, be competent and work according to the management system. Competence requirements are documented for each function affecting results, covering the schooling, qualifications, training, know-how, skills and track record each role needs.

The laboratory ensures that personnel can perform the activities they are responsible for and can judge the significance of deviations. Management communicates duties, responsibilities and authority. Procedures and retained records cover six topics: deciding competence requirements, selection, training, supervision, authorisation and monitoring of competence.

The sixth provision, covered in its own guide, requires authorisation for specific activities including work on methods, analysis of results and the review and release of reports.

The outputs are defined competence criteria, evidence that each person meets them for the tasks assigned, and a working link from competence to permission to act.

What does the requirement mean?

Define the competence needed for each relevant function, considering the education, qualifications, knowledge, skills, training and experience required for that work. Ensure people understand their duties and authority. Personnel must be able to perform their assigned activities and evaluate the significance of deviations, not merely repeat the usual sequence when everything goes well.

The laboratory needs procedures and records for determining requirements, selecting people, training, supervision, authorisation and monitoring competence. Specific authorisations include activities such as method work, result analysis and report review or approval. These are related but different capabilities; one broad job title may conceal important limits.

How can a laboratory implement this proportionately?

Start with the work rather than a generic training calendar. Identify decisions requiring demonstrated capability: preparation, instrument operation, calculation, unusual-result review, uncertainty evaluation and report approval. Define the criteria for each responsibility and decide what evidence can show those criteria are met.

Sterling recommends combining evidence appropriate to the task. Supervised work, observation, technical discussion, comparison of results and review of completed records may each contribute. Select methods that reveal actual performance. A written quiz alone may establish knowledge but miss whether someone recognises an unsuitable sample or responds correctly to a failed check.

Record any limitations, supervision needs and authorisation decisions. Plan how to maintain coverage when a key person is absent. Review capability when methods, equipment or responsibilities change and when performance suggests a concern. These are practical ways of operating the requirement, not a prescribed universal competence matrix.

Why personnel competence matters to the business

A result is only as reliable as the person who produced and checked it. Customers cannot see the skills behind a report, so they rely on the laboratory's ability to demonstrate them. When competence is assumed from job titles or training attendance, errors come in through the unexamined gap between knowing about a method and being able to run it.

There is a cost angle too. Clear criteria let managers train for the gaps that matter instead of repeating general courses. Task-specific authorisation reduces the risk of costly reruns and recalls, and gives assessors an easy way to see that the laboratory knows who can do what.

How to implement clause 6.2

Define competence by the work, then collect evidence that fits the task, not just the person.

1. List the functions that influence results and, for each, write the knowledge, skills and experience needed in plain terms.
2. Decide what evidence can show each criterion is met, such as observed work, technical discussion, comparison of results or review of completed records.
3. Set up selection, induction and training steps that lead to those criteria, with supervision while capability is being built.
4. Record authorisation decisions with their limits, and record any supervision needed.
5. Plan monitoring that continues after authorisation, for instance periodic observation and review of results.
6. Include temporary staff, report approvers and those who handle data or permissions, and review criteria when methods or equipment change.
7. Share the competence picture with management so that gaps, cover problems and training needs feed into planning, not only into individual files. Record the actions agreed and check in later whether they worked.

Manufacturing example: moving to a different method

Construction example: work at a temporary site

A construction materials laboratory sends a technician to a temporary project location. The person can perform the test in the main laboratory, but the site introduces different handling, environmental and communication conditions. Capability must include the duties assigned at that location.

A useful preparation review asks whether the technician can recognise unsuitable conditions, preserve records and escalate deviations when the usual supervisor is unavailable. The laboratory records the relevant instruction, evaluation and authority. This is an illustrative scenario; it does not mean every location requires an identical retraining programme.

What if IT or BPO staff support the laboratory?

People outside the technical team can influence data or results through assigned support duties. Consider a software administrator changing report permissions or an outsourced records team indexing technical files. Define their permitted actions, competence and escalation arrangements within the applicable laboratory controls. Do not imply that these support services are themselves accredited laboratory activities.

Evidence and common mistakes

An assessor may compare competence criteria, records, authorisations and observed work. Check whether evidence relates to the current method and responsibility. A certificate naming an employee is not enough if the laboratory cannot explain what it establishes or how performance was evaluated.

• Do not authorise everyone for every method by default.
• Do not treat a signature acknowledging a procedure as a demonstration of skill.
• Do not forget report approvers, temporary personnel or people performing relevant support work.
• Do not confuse a knowledge gap with a problem caused by unsuitable resources or unclear instructions.

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