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

共 21 条

[1] EFLM Working Group accreditation and ISO/CEN standards on dealing with ISO 15189 demands for retention of documents and examination objects
Brguljan, Pika Mesko
Thelen, Marc H. M.
Bernabeu-Andreu, Francisco A.
Kroupis, Christos
Boursier, Guilaine
Vukasovic, Ines
Barrett, Edward
Brugnoni, Duilio
Lohmander, Maria
Sprongl, Ludek
Vodnik, Tatjana
Ghita, Irina
Vanstapel, Florent
Vaubourdolle, Michel
Huisman, Willem
ADVANCES IN LABORATORY MEDICINE-AVANCES EN MEDICINA DE LABORATORIO, 2024, 5 (02): : 103 - 108
[2] Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)
Thelen, Marc H. M.
Vanstapel, Florent J. L. A.
Kroupis, Christos
Vukasovic, Ines
Boursier, Guilaime
Barrett, Edward
Bernabeu Andreu, Francisco
Brguljan, Pika Mesko
Brugnoni, Duilio
Lohmander, Maria
Sprongl, Ludek
Vodnik, Tatjana
Ghita, Irina
Vaubourdolle, Michel
Huisman, Willem
CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2015, 53 (08) : 1173 - 1180
[3] Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation
Roelofsen-de Beer, Roseri
Wielders, Jos
Boursier, Guilaine
Vodnik, Tatjana
Vanstapel, Florent
Huisman, Willem
Vukasovic, Ines
Vaubourdolle, Michel
Sonmez, Cigdem
Linko, Solveig
Brugnoni, Duilio
Kroupis, Christos
Lohmander, Maria
Sprongl, Ludek
Bernabeu-Andreu, Francisco
Brguljan, Pika Mesko
Thelen, Marc
CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2020, 58 (03) : 361 - 367
[4] ACCREDITATION OF THE METABOLIC LABORATORY UNDER THE EN ISO 15189
Stastna, S.
Maskova, V
Kostalova, E.
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JOURNAL OF INHERITED METABOLIC DISEASE, 2010, 33 : S186 - S186
[5] Revision of the ISO and EN radiation sterilization standards
Miller, A
Hansen, J
RADIATION PHYSICS AND CHEMISTRY, 2002, 63 (3-6) : 665 - 667
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Rial, Jose G.
Gonzalez, Cristina T.
dos Santos Novoa, Maria F. Pereira
Estevez, Alfonso B.
TISSUE ANTIGENS, 2013, 81 (05): : 358 - 358
[7] ISO 15189 ACCREDITATION IN CLINICAL MICROBIOLOGY LABORATORY: GENERAL CONCEPTS AND THE STATUS IN OUR LABORATORY
Akyar, Isin
MIKROBIYOLOJI BULTENI, 2009, 43 (04): : 683 - 697
[8] The role of evidence-based laboratory medicine in meeting ISO 15189:2003 standards for accreditation
Seres, E
Nagy, E
Miko, TL
Watine, J
Horvath, AR
CLINICA CHIMICA ACTA, 2005, 355 : S412 - S412
[9] Accreditation of allergen-specific IgE determination under the EN ISO 15189 standard: a French strategy
Lambert, C.
Sarrat, A.
Bienvenu, F.
Brabant, S.
Roland, Nicaise P.
Alyanakian, M-A
Apoil, P-A
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Couderc, R.
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Hemont, C.
Laine, C.
Lelong, M.
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Tabary, T.
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Uring-Lambert, B.
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Withhuhn, F.
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ALLERGY, 2015, 70 : 567 - 568
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Rogowski, Julien
Annaix, Veronique
ANNALES DE BIOLOGIE CLINIQUE, 2010, 68 (03) : 367 - 377

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