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.
The final version of ISO 9001: 2015 Quality management systems – Requirements was released on 15th September 2015. Organizations certifying to ISO 9001: 2008 must transition to ISO 9001: 2015 by September 15, 2018 and existing certification to ISO 9001: 2008 will not be valid after this date.
This is a technical revision of ISO 9001: 2008 and some of the key changes in the latest edition include:
The final version of ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes was released on 1st March 2016. Organizations certifying to ISO 13485: 2003 must transition to ISO 13485: 2016 by March 1, 2019 and existing certification to ISO 13485: 2003 will not be valid after this date.
This is a technical revision of ISO 13485:2003 and some of the key changes include:
We are working with our senior management, quality assurance teams and certification bodies to transition to ISO 9001:2015 in Q3 2018 and ISO 13485:2016 in Q1 2019. If you have any questions on NIBSCs transition plans, please contact firstname.lastname@example.org