EFLM Working Group Accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects

Autor: Meško Brguljan Pika, Thelen Marc H.M., Bernabeu-Andreu Francisco A., Kroupis Christos, Boursier Guilaine, Vukasović Ines, Barrett Edward, Brugnoni Duilio, Lohmander Maria, Šprongl Luděk, Vodnik Tatjana, Ghiţă Irina, Vanstapel Florent, Vaubourdolle Michel, Huisman Willem

Publikováno v: Advances in Laboratory Medicine, Vol 5, Iss 2, Pp 103-108 (2024)

Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a consequence, many documents, forms and reports are generated. The retention time for each of these

Externí odkaz: https://doaj.org/article/3ebb904aa9934038bca85a0ca2fe9783

Improving the laboratory result release process in the light of ISO 15189:2012 standard

Autor: Can Çubukçu, Hikmet, Vanstapel, Florent, Thelen, Marc, Bernabeu-Andreu, Francisco A., van Schrojenstein Lantman, Marith, Brugnoni, Duilio, Mesko Brguljan, Pika, Milinkovic, Neda, Linko, Solveig, Vaubourdolle, Michel, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Panteghini, Mauro, Boursier, Guilaine

Publikováno v: In Clinica Chimica Acta November 2021 522:167-173

Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation

Autor: Roelofsen-de Beer, Roseri, Wielders, Jos, Boursier, Guilaine, Vodnik, Tatjana, Vanstapel, Florent, Huisman, Willem, Vukasović, Ines, Vaubourdolle, Michel, Sönmez, Çiğdem, Linko, Solveig, Brugnoni, Duilio, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Bernabeu- Andreu, Francisco, Meško Brguljan, Pika, Thelen, Marc

Publikováno v: Clinical Chemistry and Laboratory Medicine, 58, 3, pp. 361-367
Clinical chemistry and laboratory medicine, vol. 58, no. 3, pp. 361-367, 2020.
Clinical Chemistry and Laboratory Medicine, 58, 361-367

This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about va

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b0e446f8f72c5cbb44d129e1548678c
https://hdl.handle.net/2066/217437

Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

Autor: Thelen Marc. Vanstapel Florent, Meško Brguljan Pika, Gouget Brnard, Boursier Guilaine, Barrett Edward, Kroupis Christos, Lohmander Maria, Šprongl Luděk, Vodnik Tatjana, Bernabeu-Andreu Francisco, Vukasović Ines, Sönmez Çiğdem, Linko Solveig, Brugnoni Duilio, Vaubourdolle Michel, Huisman Willem, Panteghini Mauro

ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceabili

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=57a035e5b1ae::c8d5ddba0b2d0721f0e70ef30f6a297e
https://doi.org/10.1515/cclm-2018-1212.

Recommendation for the review of biological reference intervals in medical laboratories (vol 54, pg 1893, 2016)

Autor: Henny, Joseph Vassault, Anne Boursier, Guilaine Vukasovic, Ines Brguljan, Pika Mesko Lohmander, Maria Ghita, Irina and Andreu, Francisco A. Bernabeu Kroupis, Christos Sprongl, Ludek and Thelen, Marc H. M. Vanstapel, Florent J. L. A. Vodnik, Tatjana Huisman, Willem Vaubourdolle, Michel Working Grp Accreditatio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______2127::78c0562ff61df2544ef5392ebd25d8e3
https://pergamos.lib.uoa.gr/uoa/dl/object/uoadl:3174226