Quality Management and Certification of Services in Assisted Reproductive Technology Units (ARTUs): A Review of Practices and Policy Proposals for Improving Patient-Centered Outcomes

Assisted Reproductive Technology Units (ARTUs) constitute a rapidly growing sector in healthcare, where service quality and patient safety are closely intertwined with ethical principles, technological precision, and managerial efficiency. This study aims to explore quality management practices and certification standards—such as ISO 9001, ISO 15189, and ISO 13485—within ARTUs, with the goal of developing a model that enhances patient-centered outcomes. The analysis focuses on the roles of leadership, staff training, and internal auditing mechanisms as key factors for the successful implementation of quality management systems (QMSs). Through a structured literature review and thematic synthesis, this study identifies challenges that ARTUs face in aligning with international standards and highlights strategies that strengthen patient trust, transparency, and continuous improvement. The proposed model connects measurable quality indicators with patient perceptions and experiences, providing a comprehensive framework for sustainable quality development. This article contributes to the academic discourse on healthcare quality governance and offers practical insights for policymakers and administrators seeking to improve patient experience and organizational resilience in reproductive medicine.