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March 16, 2026Journal of Clinical Laboratory AnalysisOpen Access

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

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Authors

MWMengqi WeiMLMingyang LiYLYu Lin

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Overview

This case study demonstrates a hybrid model for risk management in clinical laboratory automation, indicating improved safety and quality.

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.

Cite This Study

Wei et al. (2026) studied this question.

synapsesocial.com/papers/69b79e968166e15b153ac186https://doi.org/10.1002/jcla.70194
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