Sanmina-SCI's Guadalajara facility achieves ISO 13485 certification for medical products
May 25, 2005
EMS company achieves key medical certifications in low-cost region to support medical OEM customers with high-standard, quality and FDA-regulated manufacturing services
Sanmina-SCI Corporation (Nasdaq: SANM) announced that its Guadalajara, Mexico facility has received ISO 13485:2003 certification for medical products manufacturing. The newest certification represents a significant milestone for Sanmina-SCI's Medical Division and Guadalajara facility, demonstrating a commitment to quality and customer service to medical original equipment manufacturers (OEMs) that manufacture in Mexico.
ISO 13485 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. In order to obtain the certification, Sanmina-SCI demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical device manufacturing and related services.
"We are very pleased to have received the ISO/13485 certification which demonstrates Sanmina-SCI's unwavering commitment to maintain the highest medical manufacturing standards in the EMS industry," said Gelston Howell, Senior Vice President of Sanmina-SCI's Medical Division. "We continue to drive efficiencies in Mexico, providing all of our customers with a total manufacturing solution at the highest quality level. We are extremely proud of this certification and will continue to advance our quality efforts to ensure the success of our customers in the medical device marketplace."
Sanmina-SCI manufacturing facilities are focused on balancing quality issues with customer demand for today's and tomorrow's global business environment. Quality certification initiatives and quality tool programs, such as Six Sigma, embed quality thinking into every level of Sanmina-SCI's operation.
Sanmina-SCI's Medical Division leverages more than 20 years of experience and is the largest provider of medical electronic manufacturing services in the world. As one of the few dedicated medical manufacturing divisions in the EMS industry, Sanmina-SCI's Medical Division provides a true "end-to-end" solution for bringing medical devices to market, leveraging a vertically integrated business model specializing in low-volume, high-mix systems, as well as higher-volume devices for the medical industry.