Published on: 28th July 2020
Newry engineering firm, Exact Group, has achieved medical device compliance international accreditation, ISO 13485 during lockdown following diversification in to a new sector.
ISO 13485 is a quality management system which is required when organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and other regulatory requirements.
Renowned for working in the aerospace, agricultural and automotive industries, with the coronavirus pandemic came the opportunity to diversify into other sectors and entrepreneur and managing director, Stephen Cromie isn’t known for resting on his laurels.
Stephen Cromie explains; “When lockdown happened my first thought was my staff and keeping them safe. Then it quickly turned to; if I need to work or bring some staff back to meet key customers’ orders what do I need. That’s when I came up with our own foot pump activated hand sanister. This quickly expanded to various sizes of the units.”
Exact’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 accreditation confirms that Exact is working in accordance with the strict standards for medical device quality.
“Holding other ISOs and various quality accreditations it was important to me and the company to ensure we were certified. As a result we quickly engaged our team is verified as a company that abides by required regulations and demonstrates a commitment to maintaining the safety and quality of medical devices
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, particularly
This award adds to the Exact Groups’s portfolio of industry recognised accreditations: SC21 Silver, ISO 9001 and AS9100.