ISO 15189 is an international quality and competence standard for medical laboratories. It defines requirements for laboratory management, staff competence, document control, equipment calibration, traceability, test validation, and the handling of samples and results. A laboratory that is accredited to ISO 15189 has demonstrated that its processes are controlled and consistent enough to support reliable clinical testing.
In cyber security, ISO 15189 matters because laboratories depend on the integrity and availability of digital systems that store patient data, manage instruments, and deliver results. Ransomware, unauthorized access, or data tampering can interrupt diagnostics and undermine trust in test outcomes. While the standard is not a security framework by itself, its emphasis on records, change control, backup discipline, and operational continuity supports defense. For defenders, ISO 15189 can help reduce error paths that attackers exploit, and it gives incident responders a baseline for proving which systems, samples, and results were affected.