GLS Thermoplastic Elastomers, a PolyOne business and global leader in high-performance, custom-formulated thermoplastic elastomers (TPEs), recently announced receiving an ISO 13485:2003 certification for its manufacturing plant located in the Suzhou Industrial Park in Suzhou, China. ISO 13485:2003 is the standard that represents the requirements for a comprehensive management system used in the design and manufacture of medical devices. It is typically harmonized with ISO 9001 certification, which GLS achieved in 2007 for its Suzhou facility after having been in operation for less than one year.
The GLS facility, which opened in June 2006, provides regional and global medical device OEMs with a full range of TPE material solutions. ISO 13485 augments ISO 9001 to better focus on fundamental concerns of the medical industry, including:
-- Promotion and awareness of medical regulatory requirements as a quality management responsibility
-- Controlling the work environment for product safety
-- Specific requirements for inspection and traceability
-- Requirements for verification of corrective and preventive action effectiveness