Present-day quality consciousness, as reflected in the newest European Directives and guidelines, demands from laboratories working with human gametes and embryos that attention be paid to risk analysis and management. Using these Directives and guidelines as reference, while also aiming at accreditation, we have worked out an approach for risk analysis in the fertility laboratory and semen bank for the processing of semen to be used for intrauterine insemination and for the preservation of semen in the semen bank, based on the general principles of failure mode and effect analysis. In this overview, we describe how risk analyses and various aspects of risk management in the fertility laboratory and semen bank can be carried out.