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Medical laboratories

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​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 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 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 reso​lution (download pdf).

Requirements and guidelines (updated 19th​ of February 2024)

Accreditation requirement for medical laboratories is one of these standards:

SFS-EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

It is confirmed that the following requirements are applied to the accreditation of clinical laboratories from 1.1.2024​

  • SFS-EN ISO 15189:2022 Medical laboratories - Requirements for quality and competence

The standard replaces SFS-EN ISO 15189:2013 (EN ISO 15189:2012). 

The transition period is until 06.12.2025. 

​Mandatory guidelines relating to accreditation of medical laboratories

​Guidelines relating to medical laboratories

Examples of guidelines for medical laboratories are given below. The list does not necessarily cover all guidelines prepared for the accredited activities. Guidelines relating to testing are published by Eurachem and Eurolab​ on their websites.

Note: The links to the ILAC guidelines are download links: ​

​Publications of FINAS that support the activity of testing laboratories

Accreditation symbol​

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 medical laboratories use an identifier in which the identification number of the accredited body is of the format TXXX.

 

laboratories; healthcare; clinical; accreditation; medical

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