Keystone Manufacturing Earns
International Quality Management Certification
ISO 13485:2003 Certifies Company to Expand Medical Device Manufacturing Capabilities
Kalamazoo, Mich., Nov. 17, 2008 – Keystone Solutions Group today announced that 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,” said 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.
Keystone Solutions Group is a member of the West Michigan Medical Device Consortium.
Keystone Solutions Group
Keystone Solutions Group (www.keystone-pd.com) provides development, supply chain management and contract manufacturing for the medical device, automotive, aerospace and specialty products industries. Established in 1997, the Keystone group of companies includes Keystone Product Development and Keystone Manufacturing. Keystone Product Development provides engineering services, resource procurement and project management consulting to clients. Keystone Manufacturing handles the manufacturing, assembly, packing and distribution of products and devices. The company has locations in Grand Rapids, Mich. and Kalamazoo, Mich.
West Michigan Medical Device Consortium
The West Michigan Science & Technology Initiative established the West Michigan Medical Device Consortium (www.wmmdc.org) to give regional medical device companies the opportunity to collaborate and promote their expertise in the medical device industry—from concept design through manufacturing and distribution. The consortium builds collaboration around core competencies, creates opportunities to leverage those competencies, and ultimately strengthens the top and bottom line for its members.
###
Contact: Rebecca Howe, Lambert, Edwards & Associates
616-233-0500, rhowe@lambert-edwards.com