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International Organization for Standardization

Trinseo achieved two new ISO milestones in 2016: becoming ISO 13485 certified, which applies to the standards for supporting medical devices and related services, and receiving corporate ISO 9001 certification for the first time.

The Trinseo quality management system integrates the key elements of several external standards into its best practices, including the U.S. Food and Drug Administration’s Current Good Manufacturing Practices for direct and indirect food-contact and medical products, and ISO designation from the International Organization for Standardization based in Geneva, Switzerland. ISO-certified companies are proven to adhere to rigorous global quality standards.

Many of Trinseo’s plants are ISO-certified for ISO 9001 (standard quality management system), ISO 14001 (environmental management system), ISO 50001 (energy management system), and ISO/TS 16949 (automotive quality management standards and technical specification).

In 2016, Trinseo’s Schkopau, Germany and Boehlen, Germany sites successfully passed the recertification audit for both ISO 14001 and ISO 50001.

Trinseo achieved two new ISO milestones in 2016: becoming ISO 13485 certified, which applies to the standards for supporting medical devices and related services, and receiving corporate ISO 9001 certification for the first time.

ISO 13485: Certified to Better Serve the Medical Devices Market

Trinseo’s Performance Plastics/Consumer Essential Markets business received ISO 13485 certification in 2016, an achievement that reflects our continued commitment to being a trusted partner to medical device manufacturers.

ISO 13485 challenges organizations to place a greater focus on risk management and process validation to determine how to improve performance. This process entails looking at risk factors such as inventory levels, supply chain, and facilities, and implementing steps to analyze and measure processes, rather than simply having processes in place.

The ISO 13485 standard applies to Trinseo facilities and functions that manufacture and produce materials used for medical device applications, as well as global functions of technical service and development, research and development, quality, sales, and human resources. Although the standard names medical devices specifically, the processes and procedures apply to all Trinseo products being manufactured at the certified facilities.

ISO 9001: Ensuring Corporate-wide Quality Management

After an extensive quality audit at our Horgen, Switzerland regional operating center in 2016, Trinseo received corporate ISO 9001 certification for our effectively implemented quality management system. The audit assessed Trinseo’s business strategies, corporate functions, work processes, and current quality management system, as well as results in quality performance and customer satisfaction. The audit confirmed we are fully compliant with the requirements of ISO 9001 (as well as ISO/TS 16949 for automotive quality management standards). The scope of the certification includes the design and manufacture of styrenics, polycarbonate, latex binders, synthetic rubber, polymer blends and compounds, and styrene.