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Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO).
Thelen MH, Vanstapel FJ, Kroupis C, Vukasovic I, Boursier G, Barrett E, Bernabeu Andreu F, Brguljan PM, Brugnoni D, Lohmander M, Sprongl L, Vodnik T, Ghita I, Vaubourdolle M, Huisman W; Working Group Accreditation ISO/CEN standards (WG-A/ISO) of EFLM. Thelen MH, et al. Among authors: bernabeu andreu f. Clin Chem Lab Med. 2015 Jul;53(8):1173-80. doi: 10.1515/cclm-2015-0257. Clin Chem Lab Med. 2015. PMID: 26055950 Free article.
Accreditation process in European countries - an EFLM survey.
Boursier G, Vukasovic I, Brguljan PM, Lohmander M, Ghita I, Bernabeu Andreu FA, Barrett E, Brugnoni D, Kroupis C, Sprongl L, Thelen MH, Vanstapel F, Vodnik T, Huisman W, Vaubourdolle M; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Boursier G, et al. Among authors: bernabeu andreu fa. Clin Chem Lab Med. 2016 Apr;54(4):545-51. doi: 10.1515/cclm-2015-0780. Clin Chem Lab Med. 2016. PMID: 26744251 Free article. Review.
Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element.
Thelen M, Vanstapel F, Brguljan PM, Gouget B, Boursier G, Barrett E, Kroupis C, Lohmander M, Šprongl L, Vodnik T, Bernabeu-Andreu F, Vukasović I, Sönmez Ç, Linko S, Brugnoni D, Vaubourdolle M, Huisman W, Panteghini M; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). Thelen M, et al. Among authors: bernabeu andreu f. Clin Chem Lab Med. 2019 Mar 26;57(4):459-464. doi: 10.1515/cclm-2018-1212. Clin Chem Lab Med. 2019. PMID: 30511927 Free article.
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.
Roelofsen-de Beer R, Wielders J, Boursier G, Vodnik T, Vanstapel F, Huisman W, Vukasović I, Vaubourdolle M, Sönmez Ç, Linko S, Brugnoni D, Kroupis C, Lohmander M, Šprongl L, Bernabeu-Andreu F, Meško Brguljan P, Thelen M. Roelofsen-de Beer R, et al. Among authors: bernabeu andreu f. Clin Chem Lab Med. 2020 Feb 25;58(3):361-367. doi: 10.1515/cclm-2019-1053. Clin Chem Lab Med. 2020. PMID: 31714885 Free article.
Improving the laboratory result release process in the light of ISO 15189:2012 standard.
Can Çubukçu H, Vanstapel F, Thelen M, Bernabeu-Andreu FA, van Schrojenstein Lantman M, Brugnoni D, Mesko Brguljan P, Milinkovic N, Linko S, Vaubourdolle M, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Panteghini M, Boursier G; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. Can Çubukçu H, et al. Among authors: bernabeu andreu fa. Clin Chim Acta. 2021 Nov;522:167-173. doi: 10.1016/j.cca.2021.08.013. Epub 2021 Aug 18. Clin Chim Acta. 2021. PMID: 34418364
An approach for determining allowable between reagent lot variation.
van Schrojenstein Lantman M, Çubukçu HC, Boursier G, Panteghini M, Bernabeu-Andreu FA, Milinkovic N, Mesko Brguljan P, Linko S, Brugnoni D, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Vanstapel F, Thelen M; European Federation of Clinical Chemistry, Laboratory Medicine EFLM Working Group Accreditation, ISO/CEN standards WG-A/ISO. van Schrojenstein Lantman M, et al. Among authors: bernabeu andreu fa. Clin Chem Lab Med. 2022 Feb 16;60(5):681-688. doi: 10.1515/cclm-2022-0083. Print 2022 Apr 26. Clin Chem Lab Med. 2022. PMID: 35172415 Free article.
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.
Vanstapel FJLA, Orth M, Streichert T, Capoluongo ED, Oosterhuis WP, Çubukçu HC, Bernabeu-Andreu FA, Thelen M, Jacobs LHJ, Linko S, Bhattoa HP, Bossuyt PMM, Meško Brguljan P, Boursier G, Cobbaert CM, Neumaier M. Vanstapel FJLA, et al. Among authors: bernabeu andreu fa. Clin Chem Lab Med. 2023 Jan 31;61(4):608-626. doi: 10.1515/cclm-2023-0045. Print 2023 Mar 28. Clin Chem Lab Med. 2023. PMID: 36716120 Free article. Review.
APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.
Çubukçu HC, Vanstapel F, Thelen M, van Schrojenstein Lantman M, Bernabeu-Andreu FA, Meško Brguljan P, Milinkovic N, Linko S, Panteghini M, Boursier G. Çubukçu HC, et al. Among authors: bernabeu andreu fa. Clin Chem Lab Med. 2023 Nov 17;62(4):597-607. doi: 10.1515/cclm-2023-0740. Print 2024 Mar 25. Clin Chem Lab Med. 2023. PMID: 37978287 Free article.
Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results.
López Yeste ML, Izquierdo Álvarez S, Pons Mas AR, Álvarez Domínguez L, Marqués García F, Rodríguez MPC, Blanco Font A, Bernabeu Andreu FA, García Álvarez A, Contreras Sanfeliciano T, Pascual Gómez N, Sánchez Gancedo L, Guiñón Muñoz L. López Yeste ML, et al. Among authors: bernabeu andreu fa. Adv Lab Med. 2021 Jan 11;2(1):51-70. doi: 10.1515/almed-2020-0110. eCollection 2021 Mar. Adv Lab Med. 2021. PMID: 37359206 Free PMC article.
Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management.
López Yeste ML, Pons Mas AR, Guiñón Muñoz L, Izquierdo Álvarez S, García FM, Blanco Font A, Pascual Gómez NF, Sánchez Gancedo L, García Álvarez A, Bernabeu Andreu FA, Chueca Rodríguez MP, Álvarez Domínguez L. López Yeste ML, et al. Among authors: bernabeu andreu fa. Adv Lab Med. 2021 May 31;2(3):373-389. doi: 10.1515/almed-2021-0044. eCollection 2021 Aug. Adv Lab Med. 2021. PMID: 37362414 Free PMC article.
18 results