ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 5.4.2: Quality management

What does 5.4.2 require?

The laboratory shall have people who, whatever else they are responsible for, hold the authority and resources to: put the management system in place, keep it running and improve it; spot departures from the system or from procedures; start action to prevent departures or limit them; report to management on how the system is performing and where it needs improving; and make sure laboratory activities are effective. One person or several may hold these responsibilities.

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