ITL achieves double ISO 13485:2016 recertification

20 January 2021 News

We are pleased to announce that ITL has received ISO 13485:2016 recertification for its Quality Management System throughout its UK and US operations. Recertification to the industry standard demonstrates our commitment quality and delivery of safe, reliable medical devices and diagnostics.


In September, BSI carried out the ISO 13485:2016 recertification audit at our headquarters in Kent, UK. Following the audit, we were recommended for continuing certification pending an onsite audit at our US manufacturing facility in Ashland, Virginia.

ITL Virginia Inc, which is listed on our ISO 13485:2016 certificate as an additional site, underwent an annual surveillance audit on the 23rd and 24th of September and was successfully recommended for recertification.

Andrew Goodenough, Regulatory Affairs and Quality Assurance Manager commented, “We are delighted to have our quality processes repeatedly recognized with formal certification. It demonstrates our global commitment to quality, to meeting customer needs and international regulatory requirements, as well as helping our customers enhance the safety and conformity of their medical devices.

Tom Cole, Managing Director, commented, “Achieving recertification is a great accomplishment by our respective site teams and an excellent example of ITL’s commitment to delivering the highest levels of quality and regulatory compliance to our customers.