Newry based engineering firm, Exact Group, during the lockdown period, has achieved the medical device compliance international accreditation, ISO 13485, adding to the company’s already prolific Aerospace and Defence accreditations and awards.
ISO 13485 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, this accreditation was sought and gained by the Exact Group during the coronavirus pandemic. This 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, “I am delighted that we have achieved this medical accreditation, which clearly reinforces our commitment to quality and process excellence. I would like to thank our Quality Manager, Dermot Kelly and his team, for gaining this accreditation during these challenging times. Dermot was only appointed as Quality and Continuous Improvement Manager in February this year, several 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. Well done to all and thank you.”
The Exact Group’s process-oriented approach to operations and their 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,” continued Stephen. “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.”
With a wealth of precision engineering experience, coupled with cutting edge equipment and techniques, the Exact Group is known widely for their quality, performance and delivery. This award adds to the Exact Groups’s portfolio of industry recognised accreditations: SC21 Silver, ISO 9001 and AS9100.