EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes

被引：0

作者：

Linko, Solveig ^{[1
]}

Boursier, Guilaine ^{[2
,3
]}

Bernabeu-Andreu, Francisco A. ^{[4
]}

Dzneladze, Nana ^{[5
]}

Vanstapel, Florent ^{[6
,7
]}

Brguljan, Pika Mesko ^{[8
]}

Tosheska-Trajkovska, Katerina ^{[2
]}

Mehay, Helene ^{[9
]}

Panteghini, Mauro ^{[10
]}

Brugnoni, Duilio ^{[11
]}

Milinkovic, Neda ^{[12
]}

Lohmander, Maria ^{[13
]}

Sprongl, Ludek ^{[14
]}

Cubukcu, Hikmet Can ^{[15
]}

Thelen, Marc ^{[16
,17
]}

机构：

[1] Linko Q Solut, FI-00950 Helsinki, Finland

[2] CHU Montpellier, Dept Genet, Rare Dis & Personalized Med Rare Dis & Autoinflamm, Montpellier, France

[3] Univ Ss Kiril & Metodij, Fac Med, Dept Med & Expt Biochem, Skopje, North Macedonia

[4] Anal Clin Hosp Univ Puerta Hierro, Serv Bioquim, Majadahonda, Madrid, Spain

[5] Aversi Clin, Lab Dept, Tbilisi, Georgia

[6] Univ Hosp Leuven, Lab Med, Leuven, Belgium

[7] Katholieke Univ Leuven, Dept Publ Hlth, Biomed Sci Grp, Leuven, Belgium

[8] Univ Clin Resp & Allerg Dis, Dept Clin Chem, Golnik, Slovenia

[9] COFRAC French Accreditat Comm, Healthcare Div, Paris, France

[10] Nicolaus Copernicus Univ Torun, Dept Lab Med, Ludw Rydygier Coll Med Bydgoszcz, Torun, Poland

[11] Sped Civili, Cent Lab Clin Chem, Brescia, Italy

[12] Univ Belgrade, Fac Pharm, Dept Med Biochem, Belgrade, Serbia

[13] Sahlgrens Univ Hosp, Klin Kemi, Gothenburg, Sweden

[14] Hosp Kladno, Clin Lab, Kladno, Czech Republic

[15] Turkish Minist Hlth, Dept Rare Dis, Gen Directorate Hlth Serv, Ankara, Turkiye

[16] SKML, Nijmegen, Netherlands

[17] Radboud Univ Nijmegen, Med Ctr, Dept Lab Med, Nijmegen, Netherlands

来源：

CLINICAL CHEMISTRY AND LABORATORY MEDICINE | 2025年

关键词：

accreditation; EN ISO 15189; EN ISO 22870; perspective;

D O I：

10.1515/cclm-2024-1451

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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.

引用

页数：15