Both standards are internationally recognised quality standards for laboratories, but differ in their focus of application:
| Feature | ISO 15189 | ISO/IEC 17025 |
| Target group | Medical laboratories | Testing and calibration laboratories |
| Focus | Patient-orientation, clinical relevance, diagnostics | Technical accuracy, measuring and testing expertise |
| Focal points | Pre-analysis, laboratory processes, clinical communication, patient safety | Measurement technology, traceability, calibration procedures |
| Accreditation body (DE) | DAkkS (Medical Division) | DAkkS (Testing/Calibration Department) |
In Germany, many medical laboratories work according to ISO 15189, while technical testing centres are accredited according to ISO/IEC 17025.
EQA-Schemes support the implementation of both standards through reference-based comparative values and data continuity.
