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 7.6.1: Control of data and information management: general

What does 7.6.1 require?

The laboratory shall be able to reach whatever data and information its activities require. Laboratory information systems include both computerised and manual handling of data and information (ISO 22367 A.13 deals with risks and ISO/IEC 27001 Annex A with security controls).

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