lunedì 20 marzo 2023

POCT: l'aggiornamento delle normative

POCT: updating regulations

  • February 2023

Pacchetto ISO laboratori medici • Nuova ISO 15189 • POCT da 22870 a nuova 15189 con SIPMeL • POCT in nuova ISO 15189 ---- ISO package medical laboratories - New ISO 15189 - POCT 22870 to new 15189 with SIPMeL - POCT in new ISO 15189 

Novità sulle norme ISO per l'accreditamento del Point of Care

News on ISO standards for the accreditation of the Point of Care

  • October 2022
  • Conference: 7° CONGRESSO NAZIONALE SIPMeL Medicina di Laboratorio: nuove complessità e future strategie - Corso precongressuale 1 a cura del Gruppo di Studio Point of care testing (GdS-PoCT) Evoluzione della diagnostica decentrata: aumento della domanda, capacità di risposta e regolamentazione dei PoCT ---

sabato 18 marzo 2023

New Guides for Uncertainty of Qualitative Results

  • The Journal of Applied Laboratory Medicine 8(1):217-218

  • The Eurachem/Cooperation on International Traceability in Analytical Chemistry (CITAC) guide “Evaluating Performance and Uncertainty in Qualitative Chemical Analysis” has recently been published (1).

    a number of criticisms of the guide have recently been reported, including the lack of the repeatability and reproducibility components for the accuracy of the methods (2).

     the International Organization for Standardization (ISO) has published ISO/TR 27877, which is devoted properly to statistical analysis for evaluating the precision of binary measurement methods and their results (3).

    The approach for medical laboratories should be simple, low burden, as designed by ISO 20914, but inclusive of qualitative tests (tests with nominal results), and tests with ordinal results alongside numerical results of the internal response signal(s).

    martedì 16 agosto 2022

    Quality of medical laboratories, development of new ISO standards


    Marco Pradella - Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL), National Commission on Quality and Accreditation

    Keywords: accreditation; medical laboratories; ISO 15189

    Quality and competence requirements for medical laboratories are defined by ISO document 15189.

    Alongside this, ISO has a substantial package of standards for medical laboratories.

    These months ISO 15189 is undergoing revision, expected conclusion at the end of 2022. The revision takes ISO/IEC 17025:2017 as a model and inherits from ISO 9001:2015 innovations such as risk-based thinking, from ISO 17025 impartiality, confidentiality, complaint handling, management systems. Thus, there is a deep connection between the requirements of medical, forensic, anti-doping and food laboratories. In addition, the new text should be less prescriptive, risk-based, and more patient care-oriented.

    ISO/CASCO (Committee on Conformity Assessment) recommends the inclusion of ISO 22870 (POCT) and references to ISO 15190 (health and safety), ISO 22367 (risk management), ISO/TS 20658 (withdrawals). In addition, the new 15189 should be less prescriptive, risk-based, and patient care-oriented, linked to ISO documents such as 17511 (calibrations), 20914 (uncertainty), and the molecular methods package developed by ISO/TC/212 WG4.

    Other important ISO documents affecting medical laboratories are ISO 15198 (quality control), ISO 21151 (calibrations), ISO 15193 (reference methods), ISO 15195 (reference laboratories), ISO 35001 (biohazard), ISO 17822 (genomics in microbiology), ISO 20776 (antibiograms), ISO 17518 and ISO 19001 (dyes), ISO 17593 (anticoagulant monitoring), ISO 22583 (POCT supervisors), ISO 11073-90101 (POCT informatics), ISO 23640 (reagent stability), the ISO 18113X series (instrument and reagent documentation), ISO 20416 device aftermarket surveillance).

    SIPMeL has long been committed to raising awareness and understanding of ISO requirements in medical laboratories. Dedicated articles are collected on the Internet page

    Other references in: