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

Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 6.6.5: Reagents and consumables: instructions for use

What does 6.6.5 require?

Instructions for using reagents and consumables, the manufacturer's included, shall be easy to obtain, and reagents and consumables shall be used as their manufacturer specifies; any other use needs validation in line with 7.3.3.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

Other controls in Clause 6: Resource requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

6.1 6.1 Resources: general
6.2.1 6.2.1 Personnel: general
6.2.2 6.2.2 Competence requirements
6.2.3 6.2.3 Authorization
6.2.4 6.2.4 Continuing education and professional development
6.2.5 6.2.5 Personnel records
6.3.1 6.3.1 Facilities and environmental conditions: general
6.3.2 6.3.2 Facility controls

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