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

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-2023-0003Search in Google Scholar

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

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/healthcare11030429Search in Google Scholar

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

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:PDFSearch in Google Scholar

6. Iso/iec 15189:2007[Internet]. ISO. 2020 [cited 2023 13.03.2023]. Available https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-2:v1:enSearch in Google Scholar

7. Iso/iec 15189:2007[Internet]. ISO. 2020 [cited 2023 13.03.2023]. Available https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-2:v1:enSearch in Google Scholar

8. Iso/iec 15189:2012 [Internet]. ISO. 2020 [cited 2023 13.03.2023]. Available https://www.iso.org/standard/56115.htmlSearch in Google Scholar

9. Cobas 8800 System [Internet]. [cited 2023 13.03.2023]. Available from: https://elabdoc-prod.roche.com/eLD/web/pi/en/products/INS_2694Search in Google Scholar

10. International Vocabulary of Metrology Fourth edition - Committee Draft (VIM4 CD) 11 January 2021 [Internet]. [cited 2023 13.03.2023]. Available from: https://www.bipm. org/documents/20126/54295284/VIM4_CD_210111c.pdf/a57419b7-790f-2cca-f7c9-25d54d049bf6Search in Google Scholar

11. Iso/iec 15189:2022 [Internet]. ISO. 2020 [cited 2023 13.03.2023]. https://www.iso.org/standard/76677.htmlSearch in Google Scholar

12. Iso/iec 17025:2017[Internet]. ISO. 2020 [cited 2023 13.03.2023]. https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:enSearch in Google Scholar

13. Iso/iec 17043:2010 [Internet]. ISO. 2020 [cited 2023 13.03.2023].https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en https://www.iso.org/standard/29366. h t m l # : ~ : t e x t = I S O % 2 F I E C % 2 0 1 7 0 4 3 % 3 A 2 0 1 0 % 2 0 specifies,operation%20of%20proficiency%20testing%20 schemesSearch in Google Scholar

14. Evaluation of measurement data - Guide to the expression of uncertainty in measurement [Internet]. [cited 2023 13.03.2023].Available from: https://www.bipm.org/documents/20126/2071204/JCGM_100_2008_E.pdf/cb0ef43f-baa5-11cf-3f85-4dcd86f77bd6Search in Google Scholar

15. Health Ministry Order number 1608/2022. Monitorul Oficial 617:06.09.2007Search in Google Scholar

16. 42 CFR § 493.1250 - Condition: Analytic systems [Internet]. [cited 2023 13.03.2023]. https://www.law.cornell.edu/cfr/text/42/493.1250Search in Google Scholar

17. Oprea OR, Preda EC, Mănescu IB, Dobreanu M. Setting up an own laboratory performance-based internal quality control plan-a model for complete blood count. Rev Romana Med Lab. 2022 Oct 1;30(4):477-82. DOI: 10.2478/rrlm-2022-0036Search in Google Scholar

18. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, [Internet]. [cited 2023 13.03.2023]. Available from: https://eur-lex.europa.eu/eli/reg/2016/679/ojSearch in Google Scholar

19. Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification [Internet]. [cited 2023 13.03.2023]. Available from: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32019R0881Search in Google Scholar

20. DEPARTMENT OF DEFENSE STANDARD PRACTICE SYSTEM SAFETY MIL-STD-882E [Internet]. [cited 2023 13.03.2023]. Available from: https://eur-https://www.dau.edu/cop/armyesoh/DAU%20Sponsored%20Documents/MIL-STD-882E.pdfSearch in Google Scholar