National and international quality and safety standards within the fertility sector such as the HFEA, EU Tissue and Cells Directive and ISO, require all establishments collecting and processing human tissues and cells to implement a Quality Management System (QMS).

Quality Management

The Human Fertilisation and Embryology Authority’s 8th Code of Practice requires a licensed centre to “put in place a quality management system and implement this system to continually improve the quality and effectiveness of the service provided in accordance with the conditions of this licence and the guidance on good practice as set out in the HFEA’s Code of Practice”.

A quality management system is defined as “the organisational structure, defined responsibilities, procedures, processes and resources for implementing quality management (i.e., the co-ordinated activities to direct and control an organisation with regard to quality), including all activities which contribute to quality, directly or indirectly” (International Organization for Standardization (ISO)).

 

Compliance, Efficiency, Safety and Productivity

 

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