Next Biosciences has obtained ISO 13485 registration from Lloyd’s register Internationally, certifying that our quality management system for the “processing, storage, testing and distribution of human biological material” has met the international standard for the quality management of medical devices. This was the most rigorous quality management system available to test our procedures against to ensure that we continually strive for excellence in the way we do business and run our processes.
ISO is the International Organisation for Standardisation who publish industry standards for best practice across many industries. ISO 13485 is specifically written with medical devices in mind to take into account areas of higher accountability and risk in the medical field than would normally be required by generic quality management systems such as ISO 9001. This increased level of rigour is exactly what we aim for when dealing with each specimen we take into our laboratory and is the reason why we pursued this standard when seeking to be audited.
Due to our continual commitment to quality we chose to work with an International accredited body who assess us through various stages of audit before recommending us to their panel. Lloyd’s are themselves accredited by UKAS who in turn audit them to ensure the highest possible level of competency and reliability. Their auditors will also assess us annually to ensure continued compliance and conduct a recertification audit of our quality management system every 3 years. These audits are all conducted right here at our facilities in Midrand.