"As a global leader in power supplies for medical applications, it is imperative for us to be at the forefront of quality management", stated Scott Ziffra, vice president and general manager for marketing and solutions, Embedded Power, Emerson Network Power. "Being certified to ISO 13485 for medical equipment helps ensure that quality is designed and built into the medical product through the application of a proper quality system and helps to balance the many concerns of the medical device industry, public health and safety authorities. Not all power supply manufacturers are certified, however Emerson Network Power remains committed to helping medical equipment manufacturers get their products to market faster, cost-effectively and with less risk."
The ISO 13485 standard details the requirements for a comprehensive system of manufacturing of medical devices. It promotes management awareness and responsibility of the regulatory requirements and controls the work environment to focus the organisation on product safety and risk management. It specifies inspection, documentation, validation and traceability requirements for medical products, including corrective actions.
The Emerson Network Power factories in the Philippines operated by its Embedded Power business were also certified to ISO 9002 in 1995 and the latest version ISO 9001:2008 was received in 2010. Certification to TL 9000-H/ R4.0 Telecom Quality Management System was received in 2007, and the re-certification to the latest version TL 9000-H/ R5.0 was received in 2010. In addition, both factories have been certified to ISO 14001 Environmental Management Systems since in 1999. The factories received certification to ISO 14001:2004 and BS OHSAS 18001:2007 for the integrated environmental, occupational health and safety management systems in March 2011.