PolyOne Suzhou Achieves ISO 13485 Certification for Healthcare Quality Management

04-Aug-2010 - China

PolyOne Corporation announced that its Suzhou 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.

“PolyOne is a leading global supplier of healthcare polymer compounds,” said Dr. Willie Chien, president of PolyOne Asia. ““As market leaders, we are one of the first polymer suppliers in China to achieve this certification, which enables our healthcare compounds to meet, and exceed, our customers’ expectations while adhering to strict medical quality standards. This effort underscores our focus on customer needs as well as our commitment to providing the highest levels of quality and service.”

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.

https://www.chemeurope.com/en/news/120966/polyone-suzhou-achieves-iso-13485-certification-for-healthcare-quality-management.html