Trinseo Achieves ISO 13485 Certification for Plastics Development and Manufacturing to Support Medical Devices Business

Trinseo Achieves ISO 13485 Certification for Plastics Development and Manufacturing to Support Medical Devices Business

BERWYN, Pa. - Thursday, January 19, 2017

Trinseo (NYSE: TSE), 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.”  

ISO 13485 challenges organizations to place a greater focus than other standards on the following areas:

  • Risk Management
  • Process Validation

Organizations need to look deeper into both of these areas and determine how they can improve performance by 1.) Looking at risk factors such as inventory levels, supply chain and facilities and 2.) Implementing steps to analyze and measure processes rather than simply having processes in place.  

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. 

About Trinseo

Trinseo (NYSE: TSE), a specialty material solutions provider, partners with companies to bring ideas to life in an imaginative, smart, and sustainability-focused manner by combining its premier expertise, forward-looking innovations and best-in-class materials to unlock value for companies and consumers.

From design to manufacturing, Trinseo taps into decades of experience in diverse material solutions to address customers’ unique challenges in a wide range of industries, including consumer goods, mobility, building and construction, and medical.

Trinseo’s approximately 3,400 employees bring endless creativity to reimagining the possibilities with clients all over the world from the company’s locations in North America, Europe, and Asia Pacific. Trinseo reported net sales of approximately $4.8 billion in 2021. Discover more by visiting and connecting with Trinseo on LinkedIn, Twitter, Facebook and WeChat.

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