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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. 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.
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. 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. 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.
Recommendation for the review of biological reference intervals in medical laboratories.
Henny J, Vassault A, Boursier G, Vukasovic I, Mesko Brguljan P, Lohmander M, Ghita I, Andreu FA, Kroupis C, Sprongl L, Thelen MH, Vanstapel FJ, Vodnik T, Huisman W, Vaubourdolle M; Working Group Accreditation and ISO/CEN standards (WG-A/ISO) of the EFLM. Henny J, et al. Clin Chem Lab Med. 2016 Dec 1;54(12):1893-1900. doi: 10.1515/cclm-2016-0793. Clin Chem Lab Med. 2016. PMID: 27748267 Free article. Review.
29 results