Reading time ( words)
ITL Group (a G&H company) received ISO 13485:2016 recertification for its quality management system throughout its UK and US operations following a review by the British Standards Institute (BSI).
Last month, BSI visited ITL headquarters in Ashford, Kent to perform a recertification audit to ISO 13485:2016. The Group was recommended for continuing certification pending the outcome of an on-site audit at ITL’s manufacturing facility in Ashland, Virginia.
ITL Virginia Inc (ITL VA), which is listed on ITL’s ISO 13485 certificate as an additional site, underwent an annual surveillance audit on the 23rd and 24th September and was successfully recommended for recertification.
BSI’s consistent approach to both UK and US audits provides reassurance to ITL as a global subcontract design and manufacturing organization for ongoing compliance.
“We are delighted to have our quality processes repeatedly recognised 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,” said Andrew Goodenough, quality assurance and regulatory affairs manager.
“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,” Managing Director Tom Cole said.