Cited by 42Clinical Laboratory Practices and Quality ControlQuality and Management SystemsHealthcare Quality and Management

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Accreditation process in European countries – an EFLM survey

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Boursier, Guilaine, Vukasovic, Ines, Brguljan, Pika Mesko, Lohmander, Maria, Ghita, Irina, Bernabeu Andreu, Francisco A., Barrett, Edward, Brugnoni, Duilio, Kroupis, Christos, Sprongl, Ludek, Thelen, Marc H.M., Vanstapel, Florent, Vodnik, Tatjana, Huisman, Willem, Vaubourdolle, Michel, on behalf of the Working Group Accr·2016·Clinical Chemistry and Laboratory Medicine (CCLM)

Abstract

Accreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in the European countries but data about accreditation remain scarce. The EFLM Working Group “Accreditation and ISO/CEN standards” conducted a survey that reviews the current state of the accreditation process in European countries. An on-line questionnaire was addressed to delegates of 39 EFLM scientific societies in March 2014. One answer by country was taken into account. The survey was dealing with mandatory status, number of accredited medical laboratories in each country, possibility of flexible scope and concerned medical fields. The status of point-of-care testing (POCT) in each country was also studied. Twenty-nine responses (74%) were registered. All the assessed countries (100%) have begun an accreditation process in various ways. All the national accreditation bodies (NAB) offer or are working to offer an ISO 15189 accreditation. The accreditation process most often concerns all phases of the examination and various medical fields. Medical laboratories are responsible for POCT in 20 (69%) countries. The accreditation process for POCT, according to ISO 15189 and ISO 22870, is also developing. While there are several variations in the approaches to accreditation of medical laboratories in the European countries, the ISO 15189 accreditation project has been widely accepted. The use of a unique standard and the cooperation among countries due to scientific societies, EFLM, accreditation bodies and EA enable laboratory professionals to move toward uniform implementation of the accreditation concept.

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Research works printed but not linked: 6

  1. Huisman, 2012, European medical laboratory accreditation Present situation and steps to harmonisation, Clin Chem Lab Med, 1147, 10.1515/cclm-2011-0586 · DOI
  2. Huisman, 2007, Accreditation of medical laboratories in the European Union, Clin Chem Lab Med, 268
  3. Thelen, 1173, Flexible scope for ISO accreditation a guidance prepared by the European Federation of Clinical Chemistry and Working Group Accreditation and ISO standards WG ISO, Laboratory Medicine Clin Chem Lab Med, 15189
  4. Huisman, 2001, European communities confederation of clinical chemistry working group on accreditation past present future, Clin Chim Acta, 309
  5. Blaton, 2001, Accreditation and postgraduate training in European countries an survey Federation of of, European Societies Clinical Chemistry Clin Chim Acta, 20, 309
  6. Oosterhuis, in the European Union, Laboratory medicine Clin Chem Lab Med, 53, 2015

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Metadata

Authors
Boursier, G., Vukasovic, I., Brguljan, P. M., Lohmander, M., Ghita, I., Bernabeu Andreu, F. A., Barrett, E., Brugnoni, D., Kroupis, C., Sprongl, L., Thelen, M. H. M., Vanstapel, F., Vodnik, T., Huisman, W., Vaubourdolle, M., & on behalf of the Working Group Accr
Affiliations
  • Centre National de la Recherche Scientifique (FR)
  • NU Hospital Group (SE)
  • University Hospital Limerick (IE)
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
  • Amphia Ziekenhuis (NL)
  • Universitair Ziekenhuis Leuven (BE)
  • Univerzitetski Klinički Centar Srbije (RS)
  • Assistance Publique – Hôpitaux de Paris (FR)
Corresponding author
Boursier, Guilaine
Venue
Clinical Chemistry and Laboratory Medicine (CCLM)
Published
2016-01-01
Volume
54
Issue
4
Pages
545-51
ISSN
  • 1434-6621 (ISSN-L)
  • 1437-4331
OpenAlex
W2297718566
Cited by
42
References
6
Citations by year
2026: 4 · 2025: 2 · 2024: 2 · 2023: 5 · 2022: 5 · 2021: 4 · 2020: 7 · 2019: 2 · 2018: 4 · 2017: 3 · 2016: 3
FWCI
3.22
Type
journal article
Language
en
Open access
Locations
  • Clinical Chemistry and Laboratory Medicine (CCLM) (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
  • Social Sciences › Business, Management and Accounting › Strategy and Management › Quality and Management Systems
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Quality and Management
Keywords
laboratory accreditation, ISO 15189, point-of-care testing, European countries, medical laboratories
MeSH terms
Point-of-Care Testing, Accreditation, Europe, Humans, Surveys and Questionnaires, Medical Laboratory Science

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CoChat. (2026). Citation check: Accreditation process in European countries – an EFLM survey. https://app.cochat.ai/papers/10.1515/cclm-2015-0780
The paper
Boursier, G., Vukasovic, I., Brguljan, P. M., Lohmander, M., Ghita, I., Bernabeu Andreu, F. A., Barrett, E., Brugnoni, D., Kroupis, C., Sprongl, L., Thelen, M. H. M., Vanstapel, F., Vodnik, T., Huisman, W., Vaubourdolle, M., & on behalf of the Working Group Accr. (2016). Accreditation process in European countries – an EFLM survey. Clinical Chemistry and Laboratory Medicine (CCLM). https://doi.org/10.1515/cclm-2015-0780