Smart Electronics, which specialises in the manufacturing of bespoke electronic equipment, has achieved ISO 13485:2012 certification for its quality management system which will lead to a significant increase in business over the next two years and the creation of an additional 20 jobs.
The awarding of ISO 13485:2012 shows that Smart Electronics operates and maintains a high-quality management process for the manufacture and delivery of medical devices – in line with international standards. It is a regulatory requirement for any organisation supplying non-invasive devices to the medical sector. The company worked with assessment, verification and certification body NQA to achieve certification.
Shane Adams, managing director of Smart Electronics, said: “Obtaining this certification validates our efforts to ensure high quality at all levels of our business. We are committed to providing the highest standards and already have ISO 9001 and ISO 14001 certifications in place. This award is confirmation of our commitment to improve company performance and provide our customers with the confidence that they are dealing with an organisation devoted to providing ongoing quality.
“We are extremely proud to obtain ISO 13485:2012 certification and for an external agency to independently assess and verify the processes we have in place is a credit to all of our team.”
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