Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service

Author:

Ilinca Radu1,Chiriac Ionuț A.1,Luțescu Dan A.1,Ganea Ionela2,Hristodorescu-Grigore Smaranda3,Dănciulescu-Miulescu Rucsandra-Elena4

Affiliation:

1. 1. Medical Informatics and Biostatistics, “Carol Davila” University of Medicine and Pharmacy, Faculty of Dentistry , Bucharest , Romania

2. 2. Modern Languages, “Carol Davila” University of Medicine and Pharmacy, Faculty of Medicine , Bucuresti , Romania

3. 3. Epidemiology Department, “Gr. T. Popa” University of Medicine and Pharmacy, Faculty of Medicine , Bucuresti , Romania

4. 4. Department of Endocrinology, “ Carol Davila” University of Medicine and Pharmacy, Faculty of Dentistry , Bucuresti , Romania

Publisher

Walter de Gruyter GmbH

Reference20 articles.

1. 1. Ilinca R, Ganea I. Making the most out of proficiency testing participation for a medical laboratory from the standardization point of view. Rev Romana Med Lab. 2023;31(1):9-14. DOI: 10.2478/rrlm-2023-0003

2. 2. The EA - MLA [Internet]. [cited 2023 13.03.2023].Available from: https://european-accreditation.org/mutual-recognition/the-ea-mla/#benefits

3. 3. Kazamer A, Ilinca R, Nitu A, Iuonuț AM, Bubenek-Turconi SI, Sendlhofer G, et al. A Brief Assessment of Patient Safety Culture in Anesthesia and Intensive Care Departments. Healthcare (Basel). 2023 Feb 2;11(3):429. DOI: 10.3390/healthcare11030429

4. 4. Second edition of the accreditation standards for hospitals [Internet]. [cited 2023 13.03.2023].Available from: https://anmcs.gov.ro/en/standards/

5. 5. NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES, Commission communication in the framework of the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008, and Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 [Internet]. [cited 2023 13.03.2023]. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:348: 0001:0004:EN:PDF

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1. Cybersecurity requirement of ISO 15189 - a simplified protocol for laboratories;Revista Romana de Medicina de Laborator;2023-07-01

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