ITL Group achieves double ISO 13485:2016 recertification

ITL Group (a G&H company) receives 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 13485:2016 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.

Andrew Goodenough, Quality Assurance and Regulatory Affairs Manager commented,

“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.”

Managing Director, Tom Cole said,

“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.”



You may also like...

News
ITL increases critical instrument production during COVID-19 pandemic

As a global design and manufacturing partner of life-saving medical devices and diagnostic instruments, ITL Group (a G&H company) is an essential link in the healthcare supply chain. ITL is currently manufacturing and delivering instrumentation designed to improve respiratory function and oxygen uptake as part of a ventilator system for patients in critical care including those due to COVID-19, as well as hygiene monitoring devices and rapid diagnostic testing platforms.

Read more >

Resource
COVID-19 & MedTech: How to effectively manage supply chain disruption

It’s impossible to anticipate the arrival of global crises such as COVID-19, but the resulting impact on supply chains is putting added pressure on manufacturers worldwide – but what action can you take to build a more resilient supply chain in a time of crisis?

Read more >

Case Study
Magnasense

From lab based analysis to mobile and disposable ‘point of care testing’ (POCT)

View this case study >