ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 8.5.2: Acting on risks and opportunities for improvement

What does 8.5.2 require?

Identified risks shall be ranked and acted upon by the laboratory, with each action sized to the possible effect on examination results and on the safety of patients and staff. Decisions and actions shall be recorded, built into and carried out through the management system, and checked for effectiveness. The document does not prescribe a risk method; ISO 22367 and ISO 35001 provide guidance.

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