CONGRESS 2023 - The revised ISO 15189 standard and the impact upon delivery and maintenance of effective quality management within Point-of-Care Testing

ISO15189:2012 had reached its periodic review date and there was international consensus that it needed revision. The new version was published on 6th December 2022 and there are some key changes which include an emphasis on a patient-focused approach and to promote the welfare of patients - i.e. putting the patient at the heart of the service. There is also more emphasis on a risk based approach to the Quality Management system. In addition ISO 22870 (POCT) has been incorporated into ISO 15189:2022. This presentation will review POCT definitions, highlight key considerations for currently accredited POCT services and also for organisations considering applying for accreditation to include (or extend) POCT in their scope. POCT is referenced implicitly throughout ISO 15189:2022 and with additional distinct requirements as an Annex A. The presentation will discuss generic POCT services, and highlight considerations on both current POCT services and also emphasise considerations for planning new POCT services, and that overall, when compared with ISO 22870:2016, things have not changed as much as one would think. Principles are similar, and POCT could even be considered as another specialty within pathology, regardless of where it is or managed from.

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