The EU Tissue and Cells Directives (EUTCD) to establish quality and safety standards for the handling of human tissues and cells require tissue establishments to adopt a quality assurance approach that will help to ensure that patients obtain the services they need and in the place that they need them.
By implementing quality management systems to maintain and improve the quality of service, establishments can demonstrate compliance to patients, assessment bodies and regulatory authorities. Within the UK, the Human Fertilisation and Embryology Authority (HFEA) and Human Tissue Authority (HTA) act as the competent authorities for the Directive.
Compliance with legal and regulatory requirements enables tissue establishments to ensure that patients can access the services they need, when they need them. However, implementing paper-based management systems to maintain and review quality management systems could lead to issues reoccurring and risks increasing, which could impact the quality of patient care.