NIBSC is a centre of the Medicines and Healthcare products Regulatory Authority (MHRA), MHRAs terms of reference sets out NIBSC’s overarching governance arrangements.
Our governance and quality assurance systems and tools underpin all aspects of our work, enabling us to maintain our legal governance requirements, Quality Accreditation and Certification status, and comply with the Health and Safety Executive (HSE) regulations.
Our comprehensive Quality Management System is embedded within our operating structures and culture and ensures we can provide our customers and stakeholders with the level of service and high quality products they expect from us. Our customers can be assured that our Quality Management System has been externally assessed to international standards.
In line with this policy we aim to maintain our external certification and accreditation for our standards and control work (ISO 9001, ISO 13485, ISO 17025), extending the scope as appropriate to cover new tests and areas of work, and ensuring that our research governance framework is robust and fit for purpose.
NIBSC has appointed Advena Ltd as our designated European Authorised Representative (EC REP) to act as liaison between NIBSC as a manufacturer of CE-marked IVD products and represent NIBSC within relevant EU countries ensuring conformity and compliance of our IVD products with European Directives.