ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.6.2: Authorities and responsibilities for information management

What does 7.6.2 require?

The laboratory shall ensure that authorities and responsibilities for managing the information systems, including maintenance and modifications that can affect patient care, are specified; the laboratory is ultimately responsible for its information systems.

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