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Obtained ISO 13485 certification for the manufacture of medical power supplies

Google 우선 소스Published2012.02.08 18:46

Carlsbad, California [February 8, 2012] – Emerson Network Power, a business unit of Emerson (NYSE:EMR) and a leader in implementing Business-Critical Continuity™, announced today that it has obtained ISO 13485 certification to manufacture medical power supplies at its world-class production facility in the Philippines. ISO 13485 is an internationally recognized quality standard, and obtaining this certification requires the implementation of a comprehensive quality management system to consistently meet specific customer and regulatory requirements applicable to medical equipment.

Scott Ziffra, Vice President and General Manager of Embedded Power Marketing and Solutions at Emerson Network Power, stated, “As a global leader in supplying power supplies to the medical sector, it is only natural that we must achieve the highest level of quality management.” He added, “By obtaining ISO 13485 certification for medical equipment, we are operating a suitable quality system to ensure the design quality of medical products and help alleviate the concerns of the medical equipment industry and public health and safety agencies. While not all power supply manufacturers obtain this certification, Emerson Network Power is making every effort to support medical equipment manufacturers in bringing their products to market faster, more cost-effectively, and without risk.”

The ISO 13485 standard details comprehensive system requirements for the manufacture of medical equipment. This standard focuses on establishing a thorough management system with a sense of responsibility regarding regulatory requirements and controlling the work environment with an emphasis on product safety and risk management. It specifies requirements for inspection, documentation, verification, and traceability of medical products, as well as corrective actions.

In addition, Emerson Network Power Philippines, operated by the Embedded Power business unit, obtained ISO 9002 certification in 1995 and the revised ISO 9001:2008 in 2010. It obtained TL 9000-H/R4.0 Telecom Quality Management System certification in 2007 and re-certified the recently revised TL 9000-H/R5.0 in 2010. Furthermore, both plants obtained ISO 14001 Environmental Management System certification since 1999 and ISO 14001:2004 and BS OHSAS 18001:2007 certifications for the Integrated Environment, Occupational Health and Safety Measurement System in March 2011.

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