ISO 15189:2022 · Section 6 · Resource requirements
Clause 6.2: Personnel
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Reliable laboratory work depends on people who are competent for the activities they perform and supported to maintain that competence. Qualifications and experience provide a starting point, but they do not establish readiness for every examination, reporting task or equipment platform. Define requirements for each role and connect them to training, assessment and authorisation.
Induction should introduce the service, patient responsibilities, safety, confidentiality and the management system before staff work independently. Task training needs a clear scope, suitable supervision and an assessment method matched to the activity. Direct observation, review of records, problem solving exercises and comparison of examination work can provide complementary evidence. Attendance at a course alone does not show that someone can perform a task safely.
Authorise activities explicitly after satisfactory assessment. Distinguish performing an examination from reviewing results, releasing reports, providing advice or approving procedural changes. Include temporary, rotating and contracted personnel in the arrangements. Where staff work at several sites, check whether differences in equipment, workflow or escalation routes affect what they may do independently.
Plan continuing development and reassessment according to the work, risk, changes and previous performance. A long absence, revised method or significant incident may justify an earlier review. Keep personnel records protected but available to authorised reviewers. Staffing plans should consider workload, skill mix, supervision and absence cover, not simply headcount. When competence gaps are found, define temporary restrictions and support, then verify improvement before restoring independent activity. This creates a defensible connection between a person's responsibilities and demonstrated ability.
What assessors typically ask to see
- How are education, experience and task competence requirements defined for each laboratory role?
- How is a trainee supervised and prevented from independently performing activities not yet authorised?
- Which assessment methods demonstrate competence for examination, result review, reporting and advisory responsibilities?
- How are temporary staff and returning staff assessed for local equipment, procedures and escalation arrangements?
- What triggers reassessment, and how are competence gaps addressed before independent activity resumes?
Documents and records that usually provide evidence
- Personnel qualification and role requirement matrix
- Induction checklists and supervised training records
- Task competence assessment forms and observation records
- Examination and report release authorisation register
- Continuing development plans and learning records
- Staffing and skill mix review records
- Reassessment and restricted duty follow up records
Ready-made forms mapped to clause 6.2: Event / Training Attendance Register, Auditor Training & Competence Assessment, Personnel File Checklist, Personnel Orientation Checklist, Personnel Training & Continuous Professional Development Plan, Training Evaluation Form, Competence Matrix, General Competence Assessment Form, Management System Training and Competence Form, Departmental Technical Training and Competency Assessment (template for F07c–F07i), Competency Assessment Form, Personnel Authorization Matrix and 6 more in the forms library.
Common findings to avoid
- Training completion is treated as competence evidence without observing or assessing the assigned activity.
- Authorisation records do not distinguish examination work from technical review and final report release.
- Temporary personnel begin independent work before local procedures and escalation routes are assessed.
- Reassessment is overdue or ignores major method changes, prolonged absence and relevant performance concerns.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 6.2 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 6.2 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is a professional qualification sufficient evidence?
It supports suitability for the role but does not demonstrate competence for every local activity. Assess the tasks the person will actually perform, including equipment, reporting rules and response to unexpected findings. Record the scope of authorisation and any supervision or limits that remain necessary.
How often should competence be reassessed?
Set a documented programme appropriate to the activity, risk and applicable requirements. Combine planned reassessment with triggers such as changes, absence or performance concerns. Avoid choosing an interval solely for administrative convenience, and make sure staff cannot continue indefinitely on the basis of an outdated assessment.
Can one assessment cover several similar instruments?
Possibly, when the laboratory can justify that the skills and decision points are sufficiently comparable. Identify differences in operation, maintenance, troubleshooting and reporting before grouping activities. Document the rationale and include checks for important differences; do not assume that a shared manufacturer makes all platforms interchangeable for competence purposes.
Check the exact requirement in your licensed copy of the standard.
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