ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 4: General requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 4.2.1: Management of information

What does 4.2.1 require?

By means of agreements that can be enforced in law, the laboratory shall take responsibility for managing every item of patient information it collects or produces in its work, privacy and confidentiality included. Users or patients shall be told beforehand about any information the laboratory plans to make public. Apart from information the patient publishes or consents to release, all other information is treated as proprietary and confidential.

Maintained by Gerard BlokdykControl text last updated

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  • 1231 Ensure confidentiality of patient information throughout every phase of the total testing process under the laboratory's control

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