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 6.4.6: Equipment adverse incident reporting

What does 6.4.6 require?

Incidents and accidents traceable to particular equipment shall be investigated and reported, as required, to the manufacturer or supplier and to the relevant authorities. Procedures shall set out how the laboratory reacts to recalls and notices from manufacturers and carries out the actions they recommend.

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