Perfecseal, a Bemis Company, 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 5, including all continental U.S. based facilities: Philadelphia, PA; Mankato, MN; Oshkosh, WI; and New London, WI.
According to Matt Boswell, Perfecseal Director of Quality, “Perfecseal is in the process of upgrading our global ISO certifications from ISO 9001:2000 to ISO 13485:2003. We have plans for all locations to be certified to this new ISO standard by the end of 2009.”
