PolyOne Achieves ISO 13485 Certification for Masterbatch Facility, a First for China
PolyOne Corporation announced that it has achieved ISO 13485:2003 certification at its color and additives facility in Shanghai.
This is the first ISO 13485-certified facility for any North American or European masterbatch producer based in China, and is the fourth such certification for PolyOne globally. With this certification, PolyOne customers in the healthcare segment will be able to rapidly comply with China’s State Food and Drug Administration (SFDA) regulations, reducing their administrative burden and associated costs.
“PolyOne is fully committed to providing the highest performing and most advanced color and additives solutions for medical OEMs around the world,” said John Van Hulle, president, PolyOne Global Color and Additives. “This recent certification further emphasizes our commitment to the healthcare industry, providing customers peace of mind, knowing they are supplied with consistently high-quality, medical grade masterbatches.”
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 initially in 1998 for its Shanghai facility.
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