The ‘Double Helix’ model of quality monitoring: Risk mapping of quality management system during initial ISO 15189 Implementation in a medical laboratory
The high-risk points primarily lie in Examination processes, Document/record and Personnel management during the initial implementation of the ISO 15189. External assessments help identify deviations, contributing to quality performance improvement. Internal assessments enable continuous monitoring of quality issue corrections, supporting the ongoing enhancement of the QMS. The 'Double Helix' Model of Quality Monitoring ensures the stability and accelerated advancement of the quality management system in the medical laboratory.
Authors
- Chunyuan Wang
- Mengjun Luo
- Yali Zhou
- Shuzhe Yang
Institutions
- University of Electronic Science and Technology of China (CN)
- Chengdu Women's and Children's Central Hospital (CN)
Publication Details
- Journal
- PLoS ONE
- Published
- 2026-02-04
- DOI
- https://doi.org/10.1371/journal.pone.0342129
- Primary Topic
- Clinical Laboratory Practices and Quality Control
- Type
- article
- Field-Weighted Citation Impact
- 0.00