SUZHOU, China (Aug. 6, 2010) — Polymer materials specialist PolyOne Corp. has achieved ISO 13485 certification at its Suzhou facility.
The internationally recognized quality standard is tailored to organizations that manufacture medical devices and specifies requirements for a comprehensive quality management system. The company also attained the certification last year for its GLS Thermoplastic Elastomers facility also located in Suzhou.
As market leaders, PolyOne is one of the first polymer suppliers in China to achieve the ISO 13485 certification, enabling its healthcare compounds to meet and exceed its customers' expectations while adhering to strict medical quality standards, said Willie Chien, president of PolyOne Asia.
“This effort underscores our focus on customer needs as well as our commitment to providing the highest levels of quality and service,” he said.
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.