Lorom West certifies to ISO 13485: 2003 QMS for Medical Devices

Lorom West, a premier manufacturer of custom cables, wire harnesses, PCB and high quality OEM/ODM products today announced successful certification to the ISO 13485: 2003 Quality Management Standard (QMS) for Medical Devices.

The ISO 13485:2003 guideline requires that an organization demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements for medical devices and related services. This stringent certification represents more than a twelve-month commitment on the part of Lorom West's management and employees and provides medical customers with the assurance that Lorom West's products will provide the quality they demand.

In addition to ISO 13485:2003 certification, Lorom West has also deployed a new Epicor Vista ERP system, significantly enhancing the capabilities of Lorom West's management systems and tools. The new ERP system enables management of estimating, orders, scheduling, costing, inventory and quality while ensuring lean manufacturing and quality performance management.

"Medical devices represent a growing segment for our company," said Greg Gaches, President of Lorom West. "Today's announcements, in conjunction with the Lorom Shenzhen China factory receiving their ISO 13485 : 2003 certification in the middle of last year, means that Lorom is now uniquely positioned to provide both domestic and offshore production capabilities for our customer's medical device needs."

"This has been an exciting year for Lorom West," said Gail Richardson, Manager of Quality and Compliance. "In addition to today's ISO 13485:2003 certification announcement and the roll out of our ERP initiative, during the past twelve months, we also went from ISO 9001:2000 directly to ISO 9001:2008. This was a monumental team effort and serves to highlight our ongoing commitment to both product quality and to attaining the industry certifications that our customers require."

SOURCE Lorom West