EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes

Solveig Linko; Guilaine Boursier; Francisco A Bernabeu-Andreu; Nana Dzneladze; Florent Vanstapel; Pika Meško Brguljan; Katerina Tosheska-Trajkovska; Hélène Mehay; Mauro Panteghini; Duilio Brugnoni; Neda Milinkovic; Maria Lohmander; Luděk Šprongl; Hikmet Can Çubukçu; Marc Thelen

doi:10.1515/cclm-2024-1451

EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes

Clin Chem Lab Med. 2025 Jan 6. doi: 10.1515/cclm-2024-1451. Online ahead of print.

Authors

Solveig Linko¹, Guilaine Boursier^{2

3}, Francisco A Bernabeu-Andreu⁴, Nana Dzneladze⁵, Florent Vanstapel^{6

7}, Pika Meško Brguljan⁸, Katerina Tosheska-Trajkovska³, Hélène Mehay⁹, Mauro Panteghini¹⁰, Duilio Brugnoni¹¹, Neda Milinkovic¹², Maria Lohmander¹³, Luděk Šprongl¹⁴, Hikmet Can Çubukçu¹⁵, Marc Thelen^{16

17}

Affiliations

¹ Linko Q-Solutions, FI-00950 Helsinki, Finland.
² Department of Genetics, Rare Diseases and Personalized Medicine Rare Diseases and Autoinflammatory Unit, CHU Montpellier, Montpellier, France.
³ Department of Medical and Experimental Biochemistry, Faculty of Medicine, University Ss."Kiril and Metodij", Skopje, North Macedonia.
⁴ Servicio Bioquímica - Análisis Clínicos Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
⁵ Laboratory Dept. Aversi Clinic, Tbilisi, Georgia.
⁶ Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.
⁷ Department of Public Health, Biomedical Sciences Group, KU Leuven, Leuven, Belgium.
⁸ Department of Clinical Chemistry, University Clinic for Respiratory and Allergic Diseases, Golnik, Slovenia.
⁹ Healthcare Division, COFRAC French Accreditation Committee, Paris, France.
¹⁰ Department of Laboratory Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Torun, Poland.
¹¹ Central Laboratory for Clinical Chemistry, Spedali Civili, Brescia, Italy.
¹² Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
¹³ Klinisk Kemi, Sahlgrenska Universitetssjukhuset, Sweden.
¹⁴ Clinical Laboratory, Hospital Kladno, Kladno, Czech Republic.
¹⁵ Department of Rare Diseases, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye.
¹⁶ SKML, Nijmegen, The Netherlands.
¹⁷ Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.

PMID: 39752732
DOI: 10.1515/cclm-2024-1451

Abstract

The EN ISO 15189:2022 standard, titled "Medical laboratories - Requirements for quality and competence," is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1. Alignment with ISO/IEC 17025:2017, 2. Removal of unintended prescription, 3. Focus on patient interest and safety, 4. Minimization of new requirements, and 5. Improved clarity of text. Dedicating to harmonizing accreditation processes across Europe the EFLM Committee on Accreditation and ISO/CEN standards (C: A/ISO) has produced this guidance document to assist the laboratory medicine community in understanding and implementing the criteria of the EN ISO 15189 revision. Two main objectives of the guidance in educating both laboratories and accreditation bodies with their assessors as well as other stakeholders in laboratory medicine were agreed on. Firstly, to clarify the relevant changes covering all paragraphs of the standard and secondly to make an impact analysis on previous C: A/ISO guidance documents.

Keywords: EN ISO 15189; EN ISO 22870; accreditation; perspective.