For medical laboratories
Equipment calibration records for ISO 15189 medical laboratories
ISO 15189 sets the requirements for quality and competence in medical laboratories, where the equipment behind a result must be controlled, calibrated, and traceable. Axiospec gives medical laboratories one system to record each instrument, capture its calibration and verification against traceable references, and keep the equipment records an assessor expects, while interpretation of patient results stays with the laboratory.
What ISO 15189 asks of your laboratory equipment
Equipment calibration & metrological traceability
Equipment that affects examination results must be calibrated where required, with metrological traceability to reference materials or reference procedures, and records kept.
Calibration status & maintenance
Equipment must carry an identifiable calibration status and be maintained so results stay reliable, with intervals defined and tracked.
Records
Records of calibration, verification, and maintenance must be retained, attributable, and protected from unauthorized change.
How Axiospec helps ISO 15189 teams
Calibration status on every analyzer and instrument
Each instrument carries a live status (in tolerance, due, overdue, or quarantined) so staff can confirm equipment is fit for use before relying on a result.
Traceability captured per instrument
Record the reference standard or material and certificate behind each calibration so traceability is visible on the asset.
Intervals that surface before they lapse
Set a calibration interval per instrument and let Axiospec flag what is due and overdue, so no analyzer runs past its window.
Retained, attributable records
Every calibration and verification is written to a tamper-evident ledger with who, when, and the readings, ready to export as an audit pack.
See ISO 15189 in the live demo
Open a working calibration record with ISO 15189 fields already turned on. No signup, no credit card.
Axiospec is a documentation and workflow tool. It helps you produce clean, traceable records that support ISO 15189 compliance; certification depends on your own processes, scope, and assessor.
See it on your own equipment
Create a free account and switch on ISO 15189 fields in minutes, or explore the live demo first with this standard already turned on. No credit card.
Want a hand moving your data over? Talk to our team.