Requisiti organizzativi ISO 15189 per i laboratori medici. Da ISO 17025 (prove) a ISO 15189 (esami) - ISO 15189 organizational requirements for medical laboratories. From ISO 17025 (testing) to ISO 15189 (examinations).

descriptionPublicationkeyboard_double_arrow_right Article 13 Oct 2025Embargo end date: 01 Jan 2025 Italian Publisher:Tutto Misure - GMEE, l'Associazione Italiana di Misure Elettriche ed Elettroniche

Authors: Pradella, Marco;

doi: 10.5281/zenodo.17338712 , 10.5281/zenodo.17338713

Requisiti organizzativi ISO 15189 per i laboratori medici. Da ISO 17025 (prove) a ISO 15189 (esami) - ISO 15189 organizational requirements for medical laboratories. From ISO 17025 (testing) to ISO 15189 (examinations).

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Abstract

ABSTRACT Revised ISO 15189 was published in December 2022. In SIPMeL Recommendations M1, requirements are presented from chapters 5 (organization and management requirements) and 8 (management system requirements). The M1 Recommendations consider it necessary to refer to other ISO documents, not all of which are cited in ISO 15189. The M1 Recommendations also find it necessary to consider several Clinical & Laboratory Standards Institute (CLSI) documents. RIASSUNTO La norma ISO 15189 revisionata è stata pubblicata nel dicembre 2022. Nelle Raccomandazioni SIPMeL M1 vengono presentati i requisiti nei capitoli 5 (requisiti di organizzazione e direzione) e 8 (requisiti del sistema di gestione). Le Raccomandazioni M1 considerano necessario richiamare altri documenti ISO, non tutti citati in ISO 15189. Le Raccomandazioni M1 ritengono altresì necessario considerare diversi documenti di Clinical & Laboratory Standards Institute (CLSI). https://issuu.com/tutto_misure/docs/tutto_misure_n.2_-_2025

Keywords

ISO 15189, Accreditation/standards, Management

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