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, 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 medical laboratories that produce the majority of medical laboratory services in Finland are accredited.
The quality 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 (on the ILAC website).
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. The operations of the support group are transparent. More information about the operations of the support group.
Requirements and guidelines (updated 29th of April 2021)
Accreditation requirement for clinical laboratories is one of these standards:
SFS-EN ISO/IEC 17025:2017 General requirements for the competence of testing andcalibration laboratories
SFS-EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence
An additional requirement:
Togerther with standard SFS-EN ISO 15189:2013:
SFS-EN ISO 22870:2016 Point-of-care testing (POCT) -- Requirements for quality and competence
Mandatory guidelines relating to accreditation of medical laboratories
Guidelines relating to clinical laboratories
Examples of guidelines for clinical laboratories are given below. The list does not necessarily cover all guidelines prepared for the accredited activities. Guidelines relating to testing are also published by Eurachem and Eurolab. The guidelines are available at https://eurachem.org/ and https://www.eurolab.org/
Publications of FINAS that support the activity of testing laboratories
Accredited bodies are entitled to use the FINAS accreditation symbol, which consists of the FINAS logo, the accredited body's identification number and the accreditation requirement. The FINAS accreditation symbol must be used when the accredited body refers to the accreditation in its reports, for example.
Accredited clinical laboratories use an identifier in which the identification number of the accredited body is of the format TXXX.