What question did this study set out to answer?

To establish a standardized risk assessment model for laboratory automation by integrating ISO 15189:2022 and FMEA.

March 16, 2026Open Access

A Hybrid Qualitative–Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022

Key Points

To establish a standardized risk assessment model for laboratory automation by integrating ISO 15189:2022 and FMEA.
Created a hybrid qualitative-quantitative model combining FMEA and ISO 15189:2022.
Conducted risk assessments in clinical laboratory settings.
Implemented targeted interventions based on risk evaluation results.
Enhanced objectivity in risk assessment through integrated scoring system.
Significant improvements in the quality and safety of laboratory automation were observed.

Abstract

By integrating ISO 15189:2022 with the FMEA approach, a standardized risk assessment model for TLA systems was established. The qualitative-quantitative integrated scoring system enhanced the objectivity of risk evaluation, while targeted intelligent interventions substantially improved the quality and safety of laboratory automation.

A Hybrid Qualitative–Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022

Key Points

Abstract

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