Medical laboratories produce laboratory services for health care organisations in both the public and private sector, including hospitals, health centres, medical centres and nursing homes. Laboratory medicine fields covered by accreditation include clinical chemistry, haematology, clinical microbiology, immunology, genetics, pathology, clinical physiology, nuclear medicine, clinical neurophysiology and radiology.
In the health care sector, accreditation is voluntary. Laboratories use the accreditation to demonstrate to their clients they are competent in producing reliable laboratory services. All major public and private sector medical laboratories that produce the majority of medical laboratory services in Finland are accredited.
The management system of an accredited medical laboratory complies with the principles of ISO 9001. The international organisations ISO, ILAC and IAF have stated this compliance in their joint resolution (download pdf).
Requirements and guidelines (updated 26 th of Jan 2026)
Accreditation requirement for medical laboratories since 01.01.2024
- SFS-EN ISO 15189:2022 Medical laboratories - Requirements for quality and competence
- For clinical physiology, nuclear medicine, clinicl neurophysiology and radiology, the alternative requirement standard is SFS-EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
For more information please see the Finnish and Swedish pages.