medical standard promotes awareness of regulatory requirements as a key management responsibility; focusing on product safety, risk management, traceability, and design transfer activities in product development.
This achievement, which follows the accreditation of Volex’s design centre in Ireland last year, pertains to the factories in Bydgoszcz (Poland), Chennai (India), and Suzhou (China), and is further evidence of the company’s strategy to expand its presence in the healthcare market by strengthening its product portfolio and achieving the industry standards that large OEM customers require.
John Conroy, Vice President for the Healthcare Sector at Volex, comments, “These three manufacturing facilities are delivering complex interconnect products into the healthcare market, for advanced applications such as MRI (magnetic resonance imaging), X-Ray, CT (computed tomography) and Ultrasound. Achieving this standard gives Healthcare customers confidence that the necessary comprehensive quality systems are in place to control the manufacture of Volex products that form an integral part of complex customer applications.”
Conroy continues, “Whilst quality control has always been fundamental to our manufacturing approach, we have continuously evolved our processes and refined our systems to place quality assurance at the centre of operations, and help us to better serve the needs of our healthcare customers. The ISO 13485 accreditation process has encouraged us to be increasingly sensitive to risk assessments, and ensures that we dedicate ourselves to achieving the best possible quality, from new product introduction right the way through the product lifecycle.”
The ISO 13485 standard was achieved through an extensive application and audit process, which addressed all aspects of Volex’s approach to new product development in a healthcare market context, measuring the organisation’s awareness of regulatory requirements, as well as its capability to ensure product safety and risk management.
Jeff Bierman, Senior VP at Volex Group, adds “To coincide with Volex’s strategy to further develop its product portfolio and improve its manufacturing output, the ISO 13485 accreditation process demonstrates our commitment to quality control, as well as recognising an industry benchmark which our healthcare customers expect as standard. This is particularly important in product areas such as imaging, clinical diagnostics, surgical and patient monitoring, and we fully expect to develop our customer portfolio in these areas. It is significant that these three latest accreditations, across three key regions, are also part of a larger drive at Volex to achieve high quality standards globally.”