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La Rivista Italiana della Medicina di Laboratorio 2019 Dicembre;15(4):252-62

DOI: 10.23736/S1825-859X.19.00033-1

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: Italian

Requirements for medical, forensic, anti-doping and food laboratories: new ISO 15189 and ISO 17025

Marco PRADELLA

SIPMeL, Castelfranco Veneto, Treviso, Italia



The ongoing revision of ISO 15189, the standard for accreditation of medical laboratories that will be launched in 2022, shall use ISO/IEC 17025:2017 as a model. The most significant changes of ISO 17025 are introduced in the management system, now aligned with that of the ISO 9001:2015 standard. The ISO 9001:2015 standard introduced several innovations, which other ISO standards must take into account, such as the risk-based thinking. In the new ISO 17025, some issues such as impartiality, confidentiality, complaint handling and management systems have been imposed. In the new ISO 15189 a number of requirements will be transferred from ISO 17025. Discussion in the ISO working groups is intensively developing point by point to maintain the ISO 17025 standard structure without losing the specific characteristics of the medical laboratories regulated by ISO 15189.


KEY WORDS: Accreditation; ISO 15189; ISO 17025

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