PolyOne: Suzhou Facility Receives Healthcare Certification
PolyOne Corporation, a premier global provider of specialized polymer materials, services and solutions, announced that its Suzhou, China facility recently received ISO 13485 certification for the healthcare market. This internationally recognized quality standard is tailored to organizations that manufacture medical devices, and specifies requirements for a comprehensive quality management system. Last year, PolyOne also attained this certification for its GLS Thermoplastic Elastomers facility, also located in Suzhou.
According to the company, PolyOne is one of the first polymer suppliers in China to achieve this certification.
ISO 13485 supplies the framework for a wide-ranging quality management system for the design and manufacture of medical devices. Specific requirements include control measures to ensure product safety, inspection and traceability systems for implantable devices, and process validation for sterile medical devices.
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