Trinseo Achieves ISO 13485 Certification
Trinseo, the global materials company and manufacturer of plastics, latex binders and synthetic rubber, achieved a milestone late last year when its Performance Plastics / Consumer Essential Markets (CEM) business received ISO 13485 certification. ISO 13485, a designation of the International Organization for Standardization, Geneva, Switzerland, specifies the requirements for a quality management system that supports medical devices and related services.
“In order to be a true partner to our medical devices customers we wanted to take the extra step and get ISO 13485 certified so our business approach and thought processes could be completely aligned,” said Philippe Belot, business director of Trinseo’s CEM business. “Quality and risk management are extremely important in this industry and a mutual commitment to a standard such as ISO 13485 makes it much easier to work together, ensure quality output, and reduce the risk of non-compliance.”
This ISO 13485 standard applies to Trinseo facilities and functions that manufacture and produce medical compounds, as well as global functions Technical Service & Development, Research & Development, Quality, Sales and Human Resources. While naming medical devices, the processes and procedures apply to all Trinseo products being produced at the certified facilities.
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