Within the framework of the research project, a comprehensive analysis was conducted of the mechanisms through which a quality culture is formed and reproduced in contemporary embryology laboratories. The text consistently traces the evolution of managerial logic—from predominantly procedural quality control toward an integrated safety culture grounded in corrective and preventive action (CAPA) methodology, structured analysis of “near-miss” events (near-miss reporting), and continuous staff competency development as an essential condition for process reliability. Particular emphasis is placed on the deployment of technological solutions that reshape the architecture of laboratory practice: Piezo-ICSI, automation of “day-0” procedures, and the use of artificial intelligence (AI) tools for standardized assessment of morphological parameters of gametes and embryos. Drawing on provisions of international consensus documents (Vienna Consensus) and a body of studies from 2024–2025, it is shown that coupling high-technology production loops with standardized certification programs (ESHRE) reduces the contribution of the human factor while simultaneously increasing cumulative live birth rate.

assisted reproductive technologies, embryology laboratory, quality culture, risk management, key performance indicators (KPI), automation, staff training, CAPA.

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