LabQMHub Editorial Team · ISO 15189:2022 Quality Management Series
The most sophisticated analyzer in the world produces a wrong result the moment an untrained or unauthorized person misuses it. Behind every accurate laboratory result is a competent person who was trained correctly, assessed objectively, and authorized to perform that specific task — which is exactly why ISO 15189:2022 devotes an entire section of its resource requirements to personnel, ahead of equipment, facilities, or reagents.
Clause 6.2, Personnel, establishes that competence is not assumed from a diploma or a job title; it must be demonstrated, documented, and periodically reassessed for as long as a staff member continues to perform a given task. This chapter explores why that distinction matters so much in a clinical laboratory setting.
Why Personnel Competence Is the Foundation of Laboratory Quality
Every other resource requirement in ISO 15189:2022 — facilities, equipment, reagents — exists to support the work of competent personnel; none of those resources can compensate for a person who does not genuinely understand the procedure they are performing. Studies of laboratory error consistently identify human factors, not equipment failure, as a leading contributor to preventable mistakes, which is why competence management sits at the very front of the standard’s resource requirements.
Competence in this context means more than technical skill at the bench. It includes understanding why a procedure is performed a certain way, recognizing when a result looks implausible and should be questioned, and knowing when to escalate rather than proceed independently — judgment that formal qualifications alone do not guarantee and that only structured assessment can confirm.
From Job Description to Documented Authorization
ISO 15189:2022 expects laboratories to define competence requirements for every role before recruitment begins, and to verify that new staff actually meet them through structured onboarding rather than informal shadowing. Authorization to perform a specific task independently should be a documented event — a signed record confirming a defined training and assessment process was completed — not an assumption made once someone has been present in the department for a while.
This authorization-based approach also clarifies exactly what a given staff member is and is not yet cleared to perform independently, which matters enormously for scheduling, supervision, and incident investigation: when something goes wrong, the laboratory can immediately determine whether the person involved was properly authorized for that specific task.
Ongoing Competence Assessment: Training Is Not a One-Time Event
Initial training establishes a baseline, but ISO 15189:2022 requires competence to be reassessed periodically for the life of a person’s authorization — typically annually, and more frequently for high-risk or infrequently performed procedures where skill can decay between uses. This reflects a hard truth about laboratory work: technique drifts, shortcuts creep in, and knowledge of updated procedures does not automatically transfer without deliberate reassessment.
Effective competence assessment combines direct observation, review of quality control performance, unknown-sample testing, and documented knowledge checks — a multi-method approach that catches gaps a single method might miss, since a person can pass a written test while still performing a hands-on step incorrectly, or vice versa.
The Link Between Personnel Management and the Rest of the Quality System
Personnel competence connects directly to nearly every other requirement covered in this training program: a nonconforming work investigation almost always examines whether the involved staff member was properly trained and authorized, and internal audits routinely sample competence records as part of confirming the management system is genuinely, not just formally, implemented.
Laboratories that invest seriously in structured competence management tend to see measurable downstream benefits — fewer repeat errors, faster onboarding of new staff, and stronger performance during external accreditation assessments, where competence records are among the most heavily scrutinized categories of evidence.
Frequently Asked Questions
How often should laboratory staff competence be reassessed?
ISO 15189:2022 does not fix a universal interval, but annual reassessment is common practice, with more frequent checks for high-risk, complex, or infrequently performed procedures.
Can a new employee perform tests before formal authorization is complete?
No — ISO 15189:2022 expects documented authorization, following defined training and assessment, before a staff member performs a task independently and without direct supervision.
What methods are used to assess laboratory staff competence?
Common methods include direct observation of technique, review of internal quality control performance, blind or unknown-sample testing, and structured knowledge assessments, often combined for a fuller picture.
Key Takeaways
- Personnel competence, not equipment sophistication, is the leading determinant of laboratory quality and safety.
- Competence requirements should be defined for every role before recruitment, and verified through structured onboarding, not assumption.
- Authorization to perform a task independently should be a documented event tied to a defined training and assessment process.
- Competence must be reassessed periodically, since technique and knowledge can drift even for experienced staff.
- Effective assessment combines multiple methods — observation, QC review, unknown samples, and knowledge checks — since no single method catches every gap.
- Personnel records are among the most heavily scrutinized categories of evidence during external accreditation assessment.
Conclusion
A laboratory’s quality management system is only as strong as the competence of the people executing it every day. ISO 15189:2022’s personnel requirements exist precisely because technology and documentation cannot substitute for a well-trained, properly authorized, and periodically reassessed workforce.
Investing in structured competence management is not merely a compliance exercise — it is one of the highest-leverage investments a laboratory can make in reducing errors and protecting patients.
Continue exploring ISO 15189:2022’s resource requirements — facilities, equipment, and reagents — in the next courses of this training series.
Source note: this article draws on “Quality Management in Clinical Laboratory Demystified” by Dr. Taleb Chalab Cham, ISO 15189:2022, and widely recognized clinical laboratory quality references including CLSI guidelines, CAP accreditation checklists, and WHO laboratory quality guidance.
