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 8.1.1: 8.1.1 Management system: general

A management system shall be set up, documented, put into practice and maintained by the laboratory so that it supports and shows consistent achievement of this document. At minimum the system covers: responsibilities; objectives and policies; documented information; actions on risks and opportunities; continual improvement; corrective actions; evaluations and internal audits; and management reviews.

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