Quality manual project

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A skeleton quality manual has been prepared by collaboration between the British Fertility Society, Association of Clinical Embryologists and the Human Fertilisation and Embryology Authority (HFEA). A quality manual is a fundamental part of the quality management system (QMS) and is designed to encompass the ethos of clinical governance including education and training, clinical audit, clinical effectiveness, research and development, openness and risk management. It is mandatory for fertility clinics licensed by the HFEA in the UK to have a QMS in place to enable continual improvement of service. This manual is a tool that Centres can adapt to reflect their own service provision. The aim is to provide a skeleton to compliment or develop a Centre’s QMS. The aims of each section describe what the outcome should be and practical examples have been given. The examples are not exhaustive, and Centres should develop their own standard operating procedures (SOPs) to support the quality manual. Where possible, the aims and examples within the manual have been mapped to the relevant HFEA standard licence conditions included in the 8th HFEA code of practice (CoP). Examples suggest where implementation of quality standards outlined in this manual might be mapped to compliance with some HFEA standard licence conditions. Users should be aware that not all requirements of standard licence conditions or of the 1990 Human Fertilisation and Embryology Act (as amended) or HFEA Directions are mapped to this manual. Implementing a QMS on the basis of this manual would not mean that a Centre would be fully compliant with all HFEA requirements. HFEA standard licence conditions in this template are denoted by the letter T and a number, and these references are linked to a list of HFEA standard licence conditions appended at the end of the document. A standard licence condition highlighted in bold indicates that it has been mapped to the quality manual template. This should help Centres comply with mandatory HFEA requirements. The manual and the activities undertaken in implementing the manual can form part of the evidence of compliance shared with the HFEA in the course of an inspection.