John Libbey Eurotext

Annales de Biologie Clinique


New ISO standards for medical biology laboratories, prescriptions and deviations Volume 80, issue 5, September-October 2022

1 Italian Society of Clinical Pathology and Laboratory Medicine, National Commission for Quality and Accreditation. SIPMeL, Castelfranco Veneto, Italy
Correspondence: M. Pradella

ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do not seem to be justified by medical specificities and could complicate the understanding of the new requirements in medical laboratories.