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 5.1: Legal entity

What does 5.1 require?

The laboratory, or the larger organization to which it belongs, shall be a legal entity that bears legal responsibility for what it does; a government laboratory counts as a legal entity by virtue of its governmental status.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

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

5.2.1 5.2.1 Laboratory director competence
5.2.2 5.2.2 Laboratory director responsibilities
5.2.3 5.2.3 Delegation of duties
5.3.1 5.3.1 Laboratory activities: general
5.3.2 5.3.2 Conformance with requirements
5.3.3 5.3.3 Advisory activities
5.4.1 5.4.1 Structure and authority: general
5.4.2 5.4.2 Quality management

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