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 5.3.1: Laboratory activities: general

What does 5.3.1 require?

The laboratory shall define and document the scope of activities for which it claims conformity with this document, including work done away from its main premises (such as POCT and sample collection), and shall claim conformity only within that scope, which does not include activities supplied from outside on a continuing basis.

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