Human Tissue Authority (HTA)
The HTA is the regulatory body set up by the government to regulate the industry and ensure public confidence that each storage facility meets the required standards. The HTA inspects facilities routinely every two years and publishes the inspection report on their website (HTA). You can find out more about the HTA inspection process works through this link.
Our Partner UKPSS holds an open-ended licence which authorises us to process and store all transplantable material for human application. The aim of the HTA is to support public confidence by licensing organisations that store and use human tissue and we fully support this goal.
Our Partner UKPSS is very proud that it has never had any conditions placed on its licence. Licence no: 11063, last routine inspection being in March 2014.
As previously stated, the licence to operate under the HTA is a required minimum, however as an industry leader we are also accredited with the International Standards Organisation (ISO).
ISO 9001 Standard
Maintaining the very best quality management processes is a critical part of our work and UKPSS has earned internationally recognised accreditation for its quality management process. In addition to ensuring that quality management processes meet regulatory standards, it also encourages continual improvement of these processes, something UKPSS takes very seriously. The ISO 9001 Standard is issued by the International Organisation for Standardisation, which governs the standards for business and government in 162 countries. ISO 9001:2008 Certificate no: GB04/62552
ISO 13485 Standard
In addition to the above, which ensures a comprehensive management system for the design and manufacture of medical devices. Certificate no: GB07/72849.
OHIM
Our Partner UKPSS has been issued the Certificate of Registration for the Community Trade Mark as of 24/12/2009 by The Office of Harmonisation for the Internal Market. OHIM is the official trademarks and designs office of the European Union; its certificates are valid in all 27 EU countries.
National External Quality Assessment Service (NEQAS)
Oru Partner UKPSS’s Flow Cytometers are externally quality controlled by UK NEQAS. Since 1969 the United Kingdom National External Quality Assessment Service (UK NEQAS) has been providing a comprehensive world-wide service that enables laboratories to fulfil quality goals and facilitate optimal patient care.