Being certified to ISO 13485 for medical equipment helps ensure that quality is designed and built into the medical product and helps to balance the many concerns of the medical device industry, public health and safety authorities
Carlsbad, CA (PRWEB) February 07, 2012
Emerson Network Power, a business of Emerson and the global leader in enabling Business-Critical Continuity™, today announced it has received ISO 13485 certification for the manufacturing of medical power supplies in its world class factories in the Philippines. ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet the specific customer and regulatory requirements applicable to medical equipment.
“As a global leader in power supplies for medical applications, it is imperative for us to be at the forefront of quality management,” said 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 organization 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.
More information about power supply products from Emerson Network Power can be found online at http://www.Emerson.com/EmbeddedPower.
About Emerson Network Power
Emerson Network Power, a business of Emerson, is the global leader in enabling Business-Critical Continuity™ from grid to chip for telecommunication networks, data centers, health care and industrial facilities. Emerson Network Power provides innovative solutions and expertise in areas including AC and DC power and precision cooling systems, embedded computing and power, integrated racks and enclosures, power switching and controls, infrastructure management, and connectivity. All solutions are supported globally by local Emerson Network Power service technicians. For more information on Emerson Network Power's embedded power products and services for original equipment manufacturers and system integrators visit http://www.Emerson.com/EmbeddedPower. Learn more about Emerson Network Power products and services at http://www.EmersonNetworkPower.com.
Emerson, based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets through its network power, process management, industrial automation, climate technologies, and tools and storage businesses. Sales in fiscal 2011 were $24.2 billion. For more information, visit http://www.Emerson.com.
Emerson Network Power and the Emerson Network Power logo are trademarks and service marks of Emerson Electric Co. All other product or service names are the property of their respective owners. © 2012 Emerson Electric Co.
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