ISO 15189-aligned governance framework FOR clinical ai in medical laboratories: A proposed control matrix, evidence package, and risk-tiered maturity roadmap FOR verification, monitoring, and change control
Background: Artificial intelligence is increasingly used in medical laboratories, yet ISO 15189:2022 does not specify artificial-intelligence-specific thresholds, lifecycle monitoring, or change control. This study developed a proposed ISO 15189-aligned governance framework that distinguishes externally supplied system...