We were the very first cord blood bank to be licenced by the HTA, first receiving the licence in April 2006, followed by a full 3 year substantive licence in September 2006. We are also regulated by the HTA and hold licence number 22503. This was granted under regulation 7 (1), (2) and schedule 2 of the Human Tissue Quality and Safety for Human Application Regulations 2007. This allows for the procurement, testing, processing, distribution and/or import of tissues and/or cells intended for human application and the storage of tissues and/or cells intended for human application.
We are certified according to ISO 9001:2015 which ensures quality management system provide the foundation to better customer satisfaction, staff motivation and continual improvement. We are certified by BSI (number FS554566) for operating a quality management system, complying with the requirement of ISO 9001:2015. This spans procurement, storage, testing, processing, import and export, distribution and disposal of cord blood, cord tissue and dental pulp stem cells.
We were licenced by the HFEA back in September 2016 (number 0352) in accordance with the Human Fertilisation and Embryology HFEA) acts 1990 and 2008, in addition to the HFEA Code of Practice (CoP) to undertake the storage of eggs, sperm and embryos.
Genetically modified organisms (GMOs), are organisms whose genes have been artificially altered to modify their characteristics in some way or another. The GMO Regulations provide human health and safety and environmental protection from genetically modified micro-organisms (GMMs) in contained use, and human health and safety from genetically modified plants and animals. The key requirement of the GMO(CU) Regulations is to assess the risks of all contained uses and to ensure the sure that any necessary controls are put in place.
In July 2021, we were licensed by the Animal and Plant Health Agency to store category 3 animal by-products and samples.