Understanding ISO 15189
ISO 15189 is the internationally recognized standard for medical laboratory quality and competence. First published in 2003 and updated in 2012 and 2022, it provides a framework for laboratories to demonstrate their ability to produce valid results.
Key Requirements
The standard addresses both management requirements (quality management system, document control, service agreements) and technical requirements (personnel, facilities, equipment, examination processes).
Environmental Control Requirements
Section 5.2 of ISO 15189 specifically addresses premises and environmental conditions, while Section 5.3 covers laboratory equipment:
- Equipment must be capable of achieving required performance
- Environmental conditions must not adversely affect results
- Monitoring systems must be in place where relevant
- Records must document environmental conditions
How ATEK Supports ISO 15189 Compliance
ATEK’s environmental monitoring platform addresses the technical requirements of ISO 15189 related to environmental control and equipment monitoring.
Continuous Monitoring
Our sensors continuously monitor critical parameters:
- Refrigerator and freezer temperatures for sample storage
- Ambient temperature and humidity in examination areas
- Incubator conditions for culture-based testing
- Cold chain for sample transport
Documentation and Audit Trails
Every data point is automatically logged with:
- Timestamp and sensor identification
- User actions and acknowledgments
- Alarm events and responses
- Calibration and maintenance records
Quality Control Support
Configurable alerts notify staff immediately when conditions deviate from acceptable ranges, allowing prompt corrective action before sample quality is affected.