CLIA + ISO 15189 Competency Documentation in One Place
Personnel Pack documents personnel competency for both CLIA §493.1407 and ISO 15189 clause 6.2.2 — the two frameworks US labs are increasingly required to satisfy simultaneously. No additional cost. Included in LIMS BOX.
Five modules. One compliance story.
Personnel Pack covers every documentation layer both CLIA and ISO 15189 require — from initial hire through annual re-evaluation.
Personnel Records
Centralized profiles for every lab personnel member — roles, qualifications, hire dates, and credential status in one audit-ready record.
Competency Tracking
Document initial and ongoing competency assessments per CLIA §493.1407. Timestamped evaluations with supervisor sign-off and version-controlled procedures.
Training Logs
Track every training event — date, trainer, topic, and outcome. Generates the training history ISO 15189 clause 6.2.2 requires for each personnel record.
Certifications
Record license numbers, expiry dates, and issuing bodies. Stay ahead of renewals so certifications never lapse before a survey visit.
Procedure Authorizations
Procedure-specific sign-off records showing which personnel are authorized to perform each test — the documentation element both CLIA and ISO 15189 require.
Both frameworks. One system.
With COLA's 2026 authorization to evaluate labs against ISO 15189, dual-framework documentation is no longer optional. Personnel Pack v1.5 closes the gap with the three documentation elements ISO 15189 requires beyond CLIA.
CLIA §493.1407
Personnel qualifications, competency assessment (6-month initial + annual thereafter), test performance records for each testing personnel.
ISO 15189 Clause 6.2.2
Documented competency evaluations, version-controlled procedures, procedure-specific authorization records, and ongoing training evidence.
No additional cost. No new module to buy. Personnel Pack already covered 80% of the overlap. Version 1.5 closes the remaining 20%.
Survey-ready PDF export
Generate a complete personnel competency packet — assessments, training history, certifications, and authorizations — formatted for CLIA and ISO 15189 survey review. Hand the inspector a folder before they ask for one.
Internal audit log
Every competency review event is timestamped and attributed. The internal audit log gives you a defensible chain of custody for personnel documentation — exactly what ISO 15189 clause 6.2 asks for.
Ready to close your documentation gap?
Personnel Pack is included in every LIMS BOX plan. Book a demo or see what's included in each tier.