ENAC plan for accredited medical laboratories transitioning to the new ISO 15189
ENAC has recently published the transition plan that will help accredited medical laboratories to adapt to the new UNE-EN ISO 15189:2023 standard. This will enable compliance with the three-year period established by ILAC (International Laboratory Accreditation Cooperation), which sets a deadline of December 6, 2025, for all in-force medical laboratory accreditations to refer to the last review of the standard.
With this new standard, published in December 2022 replacing the text in force since 2012, ISO adapts the standard's structure on particular requirements for quality and competence of medical laboratories to that of the rest of the conformity assessment standards of the ISO 17000 series, in particular, ISO 17025:2017.
Among the main new points in this new version of the standard, it should be noted that it also establishes the requirements for analyses carried out together with the patient or point-of-care testing (POCT), previously included in ISO 22870: 2016. Likewise, the new text encourages medical laboratories to continuously improve by focusing on the benefit to the patient, since it presents requirements aimed at preventing potential risks to patients, an essential factor in a medical laboratory.
As established by ILAC, at the end of this transitional period, all laboratories accredited according to the previous version of ISO 15189, as well as those that develop accredited patient analyses according to ISO 22870: 2016, must have been assessed and accredited based on the new version of ISO 15189.
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