LOCKDOWN has given Newry engineering firm Exact Group the chance to add to its capabilities by achieving the medical device compliance international accreditation ISO 13485.
Adding to its clutch of existing aerospace and defence accreditations and awards, the marque is a quality management system that demonstrates compliance to stringent medical device quality standards that consistently meet customer and other regulatory requirements.
Renowned for working in the aerospace, marine and automotive industries, the accreditation has helped the company to maintain its workforce and contribute to the health and wellbeing of the local community.
Founder and manager director Stephen Cromie said: “Achieving this accreditation clearly reinforces our commitment to quality and process excellence, and I thank our quality manager Dermot Kelly and his team for seeking and gaining the award during these challenging times.
“Dermot was only appointed as quality and continuous improvement manager in February, just weeks before the lockdown. To quickly understand our ethos and culture, accept this challenge and succeed in this short space of time is testament to him, his team and the Exact Group.”
The Exact Group’s process-oriented approach to operations and its pre-existing commitment to quality were instrumental in successfully obtaining the certification and ensuring the implementation of compliance procedures.
“This medical ISO accreditation sets the company in good stead for working with the many companies in the pharma and medical sectors across the UK, Ireland and beyond,” Stephen added.
“In the meantime, we have designed and built our own hand sanitising foot pump operating unit, and that has been selling exceedingly well. We now hope to engage and help the wider medical industry with their engineering requirements going forward.”
