Smart Electronics achieves ISO 13485:2012 certification
Smart Electronics Ltd., which specialises in the manufacturing of bespoke electronic equipment has achieved ISO 13458:2012 certification for its quality management system.
The award means that Smart Electronics maintains a high quality management process for the design, development 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. Smart Electronics uses Almir Business as consultants to guide them through the certification process.
Jim Ryan, Director with responsibility for Quality, said: “Smart Electronics first engaged with Almir Business in 2007 to assist in setting up our quality and environmental management systems and in achieving certification to ISO9001 and ISO14001. Since then we have worked with Almir Business on a continuous basis and engaged in other projects such as the Enterprise Ireland Lean Start and Lean Plus programs. We find Almir Business very knowledgeable, reliable and easy to work with.”
Shane Adams, Managing Director of Smart Electronics, which is based in County Clare, Ireland, 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 certification 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 on-going 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 everyone here.”
Smart Electronics worked with leading assessment, verification and certification body NQA to achieve certification.
For more information about Smart Electronics visit www.smartelectronics.ie