Medical laboratories produce laboratory services for health care operators both in 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, genetics, pathology, clinical physiology, nuclear medicine and clinical neurophysiology.
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 clinical laboratories that produce the majority of medical laboratory services in Finland are accredited.
The SFS-EN ISO 15189:2013 standard aimed at medical laboratories and/or the SFS-EN ISO/IEC 17025:2017 standard common for testing laboratories are the accreditation requirements for medical laboratories. The SFS-EN ISO 15189 standard was first published in 2003 and after that, medical laboratories have begun to use this standard instead of the SFS-EN ISO/IEC 17025 standard.
The quality management system of an accredited medical laboratory meet the principles of ISO 9001 standard. The international organisations ISO, ILAC and IAF have stated this compliance in their joint resolution.
Accredited medical laboratories use the FINAS accreditation symbol in which the identification number of the accredited body is of the form TXXX.
FINAS established a technical support group for clinical analysis in 2013 to promote communication between FINAS and medical laboratories and to support the development of assessments. Operations of the support group are open and further information is available here.