Perfecseal Certifies Locations to New ISO Standard

Perfecseal (Oshkosh, Wis.) announces registration to the ISO 13485:2003 Medical Device Quality Management System for its facility in Derry, Northern Ireland. ISO 13485:2003 specifies requirements for quality management systems in which organizations demonstrate the ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.

This brings the total number of Perfecseal facilities registered to this new standard to five, including all continental U.S.-based facilities: Philadelphia, Pa.; Mankato, Minn.; Oshkosh, Wis.; and New London, Wis.

“Perfecseal is in the process of upgrading our global ISO certifications from ISO 9001:2000 to ISO 13485:2003,” says Matt Boswell, director of quality, Perfecseal. “We have plans for all locations to be certified to this new ISO standard by the end of 2009.”

Perfecseal specializes in the manufacture of co-extruded films, laminated films, flexible forming films, foil barrier films, pouches, bags, thermoformed trays, lids, labels, Perfecseal heat seal coating on DuPont Tyvek and Perfecseal heat seal coating on medical grades of paper. Perfecseal, a division of the Bemis Co., has facilities located in Oshkosh and New London, Wis.; Mankato, Minn.; Philadelphia, Pa.; San Juan, Puerto Rico; Derry, Northern Ireland; Selangor, Malaysia; and Suzhou, China.