ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.6.6: Reagents and consumables: adverse incident reporting

What does 6.6.6 require?

Where a particular reagent or consumable is behind an incident or accident, the laboratory shall investigate it and report it, as required, to the manufacturer or supplier and to the relevant authorities. Procedures shall set out how the laboratory reacts to recalls and other notices and carries out the actions they recommend.

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