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This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.
The main changes are as follows:
— Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;
— Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;
— Increased emphasis on risk management.
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