Keystone Manufacturing Earns ISO 13485:2003

Keystone Manufacturing has received ISO 13485:2003 certification for medical device manufacturing.  ISO 13485:2003 is an internationally recognized quality management standard and certification is specific to organizations that manufacture or provide medical devices.  The certification means Keystone Manufacturing can now produce medical devices that are intended for use in both the US and international markets.

ISO 13485:2003, the latest version of the ISO 13485 standard, specifies requirements for a quality management system by which an organization can demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services.

"The medical device market is a very important avenue for the continued growth and development of Keystone Solutions Group.  This certification strengthens our capabilities in this important market and positions us for further expansion of services,” says Keystone’s co-owner Mike Zamora.  “This certification means we can now serve additional customers, and we now have the option to develop our own medical devices."

Keystone Manufacturing is the manufacturing arm of Keystone Solutions Group, and handles the manufacture, assembly, packaging and distribution of Class I and II medical devices and supplies.  The company also provides quality system development and management, warehousing, order fulfillment and product distribution and shipping of their customers’ products.  Additionally, Keystone has a sales and marketing component that is available to its clients to help establish relationships with key customers.