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 6.7.1: Agreements with laboratory users

What does 6.7.1 require?

A procedure shall be used to set up agreements to provide laboratory activities and to review them periodically, making sure that: requirements are defined adequately; the laboratory is able, and resourced, to satisfy them; and users are told which activities referral laboratories and consultants carry out. Any change that could affect results shall be made known to users, and records of reviews and significant changes shall be kept.

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