ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.4.1.5: Automated selection, review, release and reporting of results

What does 7.4.1.5 require?

If results are selected, reviewed, released and reported automatically, a procedure shall make sure that: the selection criteria are defined, approved, accessible and understood by those who authorize release; before first use, the criteria have been validated and approved, reviewed on a regular basis and verified again after any change that could affect them; results picked out for manual review can be recognised, with the time of selection and review and the reviewer retrievable; and the automated process can be halted quickly when required.

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