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, 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).

Cooperation

FINAS established a technical support group for clinical analysis in 2013 to promote communication between FINAS and med​​ical 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 27th​ of February 2023)

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

• EA-2/15 M:2019 EA requirements for the accreditation of flexible scopes
• ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results

​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/

• EA-4/14 INF:2003 The Selection and Use of Reference Materials
• EA-4/18 INF:2010 Guidance on the level and frequency of proficiency testing participation
• EA-4/20 G Guidance for the Assessment of Laboratories against EN ISO 15189 and 22870
• EA-4/21 INF:2018 Guidelines for the assessment of the appropriateness of small interlaboratory comparisons within the process of laboratory accreditation (republished in July2019 for editorial updates)
• EA-4/23 inf The Assessment and Accreditation of Opinions and Interpretations using ISO/IEC 17025:2017
• ILAC G8:09/2019 Guidelines on Decision Rules and Statements of Conformity
• ILAC G17:01:2021 ILAC Guidelines for Measurement Uncertainty in Testing​​
  
• ILAC G24:2022 Guidelines for the determination of recalibration intervals of measuring equipment​
  
• ILAC G26:11/2018 Guideline for the Implementation of a Medical Laboratory Accreditation System

​Publications of FINAS that support the activity of testing laboratories

• FINAS A1/2020 The principles for the assessment of sampling according to the standards SFS-EN ISO/IEC 17025:2017 and SFS-EN ISO 15189:2013
• FINAS A2/2022 Principles for the assessment of the quality assurance and proficiency testing practises in laboratories​ (PDF)
  
• FINAS A3/2022 Principles for the assessment of flexible scope (PDF)​
• FINAS A8/2016 Assessment of Impartiality – Principles Applied by FINAS  ​
• FINAS A11/2016 Principles for the Assessment of Subcontracting
  

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

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