A Hybrid Qualitative–Quantitative <scp>FMEA</scp> Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating <scp>ISO</scp> 15189:2022
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.
Authors
- Mingyang Li (ORCID: https://orcid.org/0000-0003-1446-6381)
- Yong Xia (ORCID: https://orcid.org/0000-0003-4589-9702)
- Yu Lin (ORCID: https://orcid.org/0000-0003-0006-164X)
- Bowen Li
- Hao Xue
- Mengqi Wei
Institutions
- Peking University Shenzhen Hospital (CN)
Publication Details
- Journal
- Journal of Clinical Laboratory Analysis
- Published
- 2026-03-14
- DOI
- https://doi.org/10.1002/jcla.70194
- Primary Topic
- Clinical Laboratory Practices and Quality Control
- Type
- article
- Field-Weighted Citation Impact
- 0.00