ISO publishes revision of the ISO 15189 medical laboratory accreditation
The International Organization for Standardization (ISO) has recently published ISO 15189:2022, on particular requirements for medical laboratories’ quality and competence, replacing the text in force since 2012, with the aim of adapting its structure to that of the rest of the ISO 17000 series conformity assessment standards, in particular, to ISO 17025:2017.
Although most of the requirements established in the standard’s previous version are maintained in the new text, the renewed standard focuses on the benefits to the patient and encourages medical laboratories to continuously improve. It presents requirements aimed at avoiding potential risks to patients, something essential in any clinical laboratory quality management system.
The formulated requirements of this new ISO 15189 version are much less prescriptive than the previous one, resulting in greater flexibility to demonstrate compliance with the requirements established in it, applying a more performance-oriented way of thinking.
Moreover, one of the main novelties introduced by the text is that it also establishes the requirements that until now were included in the ISO 22870 standard, related to the point-of-care testing activity (POCT), that is, to the analyzes carried out in the place where the patient is not in the laboratory itself.
Three-year transitional period
The international organization of accreditors ILAC has established a three-year transition period that will enable accredited laboratories to adapt to the new revision of the standard.
At the end of this period, all laboratories accredited according to ISO 15189:2012, as well as those developing accredited patient analyses according to ISO 22870:2016, must have been assessed and accredited based on the new version of ISO 15189. Therefore, ISO 22870 on POCT will disappear once the aforementioned transition period ends.
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