Implementing essential requirements of the ISO 17043:2023 for a proficiency testing provider as a step towards accreditation achievement

Author:

Ilinca Radu1,Luțescu Dan Adrian1,Sfeatcu Ruxandra Ionela2,Iosif Laura3,Wagner Andreea3,Țâncu Ana Maria Cristina3

Affiliation:

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

2. Department of Oral Health and Community Dentistry, Faculty of Dentistry , “Carol Davila” University of Medicine and Pharmacy , Romania

3. Department of Prosthodontics, Faculty of Dentistry , “Carol Davila” University of Medicine and Pharmacy , Romania

Abstract

Abstract Successful participation in Proficiency Testing/Interlaboratory Comparison (PT/ILC) schemes is a method to ensure validity of results for any laboratory. It is also a component of a complex of means for demonstrating technical competence of a laboratory as an organization. The new accreditation standard ISO 17043 for PT providers together with the newly updated ILAC Policy of PT participation introduce a different perspective on the activity of PT provider in regard to quality assurance. Technical and management requirements from the ISO 17043:2023 that are essential for a competent activity of PT/provider are identified with a rationale for their increased importance. This importance is related both to the practical impact on the PT/ILC providers’ customers (laboratories) activity and laboratory benefits of participation in PT/ILS schemes besides the traditional qualitative and quantitative interpretation of their participation. Identified requirements are accompanied by a practical and explained potential implementation strategy which is aligned with the ILAC Policy on PT/ILC participation. Successful implementation of the essential requirements of the ISO 17043:2023 is a necessary step for any PT/ILC provider that seeks credibility on the proficiency testing market. Such implementation may also be an important step towards full implementation of the ISO 17043:2023 and achieving accreditation thus benefiting from full confidence in the activities of the provider.

Publisher

Walter de Gruyter GmbH

Reference10 articles.

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

2. Iso/iec 15189:2022 [Internet]. ISO. 2020 [cited 2023 16.06.2023]. Available from: https://www.iso.org/standard/76677.html

3. ILAC P9:01/2024 ILAC Policy for Proficiency Testing and/or Interlaboratory comparisons other than Proficiency Testing. [Internet]. ILAC.2024; [cited 2024 June 20]. Available from: https://ilac.org/publications-and-resources/ilac-policy-series/

4. Ilinca R, Luțescu DA, Sfeatcu RI, Gherlan I, Dănciulescu-Miulescu RE, Țâncu AMC. A comprehensive review of Proficiency Testing / Interlaboratory Comparisons Policies of the EA-MLA signatories applicable to medical laboratories. Rev Romana Med Lab. 2024;32(2):123-34. DOI: 10.2478/rrlm-2024-0014

5. Iso/iec 17043:2023 [Internet]. ISO. 2020 [cited 2024 June 20]. Available from: https://www.iso.org/standard/80864.html

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