RESUMO
Assisted human reproduction has undergone rapid advances since its inception 45 years ago. To keep pace with these advances, assisted reproduction laboratories should adhere to a quality management system that addresses staffing and training, physical space and air quality, equipment maintenance and other operational matters, and ensures gamete and embryo handling in accordance with the latest quality and safety standards. Accordingly, this review aims to provide a reference document that highlights the critical aspects to consider when establishing and operating an ART laboratory. The review collates and expands upon published national and international guidelines and consensus documents, providing easier access to this large body of important information.