EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes
Jazyk angličtina Země Německo Médium electronic-print
Typ dokumentu časopisecké články
PubMed
39752732
DOI
10.1515/cclm-2024-1451
PII: cclm-2024-1451
Knihovny.cz E-zdroje
- Klíčová slova
- EN ISO 15189, EN ISO 22870, accreditation, perspective,
- MeSH
- akreditace * normy MeSH
- klinické laboratoře * normy MeSH
- laboratoře normy MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa MeSH
The EN ISO 15189:2022 standard, titled "Medical laboratories - Requirements for quality and competence," is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1. Alignment with ISO/IEC 17025:2017, 2. Removal of unintended prescription, 3. Focus on patient interest and safety, 4. Minimization of new requirements, and 5. Improved clarity of text. Dedicating to harmonizing accreditation processes across Europe the EFLM Committee on Accreditation and ISO/CEN standards (C: A/ISO) has produced this guidance document to assist the laboratory medicine community in understanding and implementing the criteria of the EN ISO 15189 revision. Two main objectives of the guidance in educating both laboratories and accreditation bodies with their assessors as well as other stakeholders in laboratory medicine were agreed on. Firstly, to clarify the relevant changes covering all paragraphs of the standard and secondly to make an impact analysis on previous C: A/ISO guidance documents.
Central Laboratory for Clinical Chemistry Spedali Civili Brescia Italy
Clinical Laboratory Hospital Kladno Kladno Czech Republic
Department of Laboratory Medicine Radboud University Medical Center Nijmegen The Netherlands
Department of Medical Biochemistry Faculty of Pharmacy University of Belgrade Belgrade Serbia
Department of Public Health Biomedical Sciences Group KU Leuven Leuven Belgium
Healthcare Division COFRAC French Accreditation Committee Paris France
Klinisk Kemi Sahlgrenska Universitetssjukhuset Sweden
Laboratory Dept Aversi Clinic Tbilisi Georgia
Laboratory Medicine University Hospital Leuven Leuven Belgium
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