Dec 4 2007
The Polymer Technology Group, Inc., a preeminent biomaterials company, announced today that it has earned ISO 13485:2003 certification from BSI Management Systems, a management systems certification and notification body. The Company also announced that it has achieved ISO 9001:2000 recertification from BSI.
ISO 13485:2003 is an internationally recognized Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a Medical Device QMS ensuring steps have been taken to identify, manage and minimize the risks involved with the manufacturing and sale of medical devices. Certification to ISO 13485:2003 reinforces to customers through an independent third-party that PTG operates its Medical Device QMS in accordance with the standard.
ISO 9001:2000 is an internationally recognized quality management system standard also developed by ISO. To be certified to the standard, companies must implement a well-documented Quality Management System (QMS) that ensures consistency and improvement of working practices, including the products and services produced. Likewise, certification to ISO 9001:2000 reinforces to customers, through an independent third-party, that PTG operates a QMS in accordance with the standard.
“PTG has always been committed to excellent performance in both our internal manufacturing and OEM business,” said Bob Ward, CEO. “The addition of the ISO 13485:2003 certification for our medical device activities demonstrates that our focus remains on quality, world-class performance and continuously monitoring our business operations to ensure that we deliver on the promises we make to our customers, employees and vendors.”