Evaluation of the Performance and Application of the ISO 9001 Standard in the Biological Laboratory (Research Article)

Author(s): Ursul Jean-Paul, Coulibaly Songuigama, Amoin Marie, Yao Gilles Privat, Marie Laure

Abstract: A cross-sectional study was conducted throughout 2024 at the ISO 9001-certified laboratory of the Institut de Cardiologie d’Abidjan integrating Key Performance Indicators (KPIs) with user and staff satisfaction data to identify strengths and areas for improvement. Performance was evaluated across the pre-analytical, analytical, and post-analytical phases using Key Performance Indicators (KPIs)—including waiting times, sample non-conformity, internal quality control (IQC) compliance, and turnaround time (TAT). Quantitative KPI data from laboratory records were triangulated with qualitative data from satisfaction surveys administered to 300 clients and all 27 staff members. The analysis revealed a dual performance profile. The pre-analytical phase was strong, with a mean waiting time (22.5 min) below the 25-minute benchmark and high client satisfaction (≥98%) for reception and hygiene, despite sporadic sample non-conformities. Analytically, IQC compliance was excellent (>95%), ensuring technical reliability.

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