Personnel
Demonstrated staff qualification, training and competence, with specific authorization for each type of test.
Facilities and environmental conditions
Biosafety, temperature and humidity conditions suited to preserving samples and reagents.
Equipment and metrological traceability
Calibration and maintenance of analytical equipment, with traceability to recognized standards.
What an auditor usually asks for
- Competence and authorization records for clinical staff
- A biosafety and environmental conditions log
- An analytical equipment calibration schedule
- Preventive maintenance records for equipment
How to cover resources in Kimobox
- 1Log each lab technician's competence and authorization in the employee portal.
- 2Set up the equipment calibration schedule with automatic alerts.
- 3Document the lab's biosafety and environmental conditions.
Every analytical equipment calibration warns you before it lapses, with its traceability linked.
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO 15189:2022 — Medical laboratories. Requirements for quality and competence ISO · December 2022
- ISO/IEC 17025:2017 — Competence of testing and calibration laboratories ISO/IEC · November 2017
- Entidad Nacional de Acreditacion ENAC · Official portal