Business News

PolyOne Achieves ISO 13485 Certification at Third Facility

Thursday 10. February 2011 - PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer solutions (TPEs), today announced that it has achieved ISO 13485:2003 certification at its McHenry, Ill. facility. T

his marks the third certification for PolyOne, and will enable PolyOne customers to rapidly comply with government-mandated supplier control standards without incurring additional costs.
“PolyOne is fully committed to providing the highest performing and most advanced TPE solutions for medical OEMs,” said Walter Ripple, general manager, PolyOne GLS Thermoplastic Elastomers. “This recent certification further emphasizes our commitment to the healthcare industry and providing customers with confidence, knowing they are supplied with consistently high-quality, medical grade TPEs.”
ISO 13485:2003 is the standard that defines 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 PolyOne achieved in 2003 for its McHenry facility.
ISO 13485 augments ISO 9001 to better focus on fundamental concerns of the healthcare 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 preventative action effectiveness
Previously, PolyOne GLS Thermoplastic Elastomers and the Engineered Materials plants in Suzhou, China achieved ISO 13485 certification in 2009 and 2010 respectively. PolyOne continues to pursue ISO13485 certifications for additional manufacturing facilities around the globe.
Ripple added, “Our recent certification underscores our commitment to world-class manufacturing practices, addressing the rigorous demands of the healthcare industry such as cleanliness, detailed record keeping, lot-to-lot product consistency, and traceability of raw materials and processing. This translates into peace of mind for our customers, knowing they can rely on PolyOne to develop and deliver products that meet the high standards for their most demanding applications.”