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 5.4.1: Structure and authority: general

What does 5.4.1 require?

The laboratory shall set out: how it is organized and managed, where it sits within any larger organization, and how management, technical work and support services relate to each other; the responsibilities, authority, reporting lines and working relationships of everyone who manages, carries out or checks work that affects results; and its procedures, in as much detail as consistent working and valid results require.

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