Alps Electric EMS achieves ISO 13485 certification

Ireland-based Alps Electric EMS has achieved ISO 13485 certification, an internationally recognised standard for quality management systems within the medical device industry, demonstrating an organisation’s ability to consistently meet customer and regulatory requirements applicable to medical devices and related services. 

The certification supports Alps Electric EMS' manufacture of medical devices and reflects the company's commitment to robust quality systems, full traceability, documentation and risk management, the company said.

Alps Electric EMS said it has developed the processes, systems, quality culture and operational disciplines required to manufacture products where consistency, precision and reliability are essential.  

By bringing SMT PCB assembly, injection moulding, painting and laser etching, automation, testing, assembly, supply chain management and fulfilment together under one roof, the company provides customers with a simplified manufacturing partner capable of supporting increasingly complex products throughout their lifecycle. 

“Medical technology is a natural fit for our business,” John Foley, Managing Director of Alps Electric EMS, said. “The disciplines, quality systems and attention to detail required by the medical sector closely align with the standards we have been applying throughout our operations for many years.”

“ISO 13485 is far more than a certificate. It reflects a culture of quality that runs throughout the organisation,” Thomas O'Leary, Senior Quality Manager at Alps Electric EMS, said. “Achieving this standard required dedication, professionalism and teamwork from colleagues across the entire business.”