Quality and governance

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.  

Quality Management System 

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. 

Certification and Accreditation

• ISO/IEC 17025:2017 accreditation for defined testing activities related to our batch release of biological medicines under UK law.
• ISO 9001:2015 certification for the design, manufacture and supply of liquid and freeze-dried biological materials. The receipt, storage, and supply of reagents for AIDS research.
• ISO 13485:2016 certification for the design and manufacture of liquid and freeze-dried biological materials.
  
• Human Tissue Authority (HTA) research licences for the storage and use of human tissue for a listed schedule purpose.
• HTA Human Application Licence held by UK Stem Cell Bank for the storage, procurement, processing, testing and distribution of human tissue for a listed schedule purpose

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.