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:
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.
Trinseo (NYSE:TSE) is a global materials solutions provider and manufacturer of plastics, latex binders, and synthetic rubber with a focus on delivering innovative, sustainable, and value-creating products that are intrinsic to our daily lives. Trinseo is dedicated to making a positive impact on society by partnering with like-minded stakeholders, and supporting the sustainability goals of our customers in a wide range of end-markets including automotive, consumer electronics, appliances, medical devices, packaging, footwear, carpet, paper and board, building and construction, and tires. Trinseo had approximately $3.8 billion in net sales with 2,700 employees globally in 2019. For more information, please visit: www.trinseo.com.
This press release may contain “forward-looking statements” including, without limitation, statements concerning plans, objectives, goals, projections, expectations, strategies, future events or performance, and underlying assumptions and other statements, which are not statements of historical facts. Forward-looking statements may be identified by the use of words like “expect,” “estimate,” “will,” “may,” or expressions of similar meaning. Forward-looking statements reflect management’s evaluation of information currently available and are based on the Company’s current expectations and assumptions regarding the impact from the COVID-19 pandemic, the Company’s business, the economy and other future conditions. Specific factors that could cause future results to differ from those expressed by the forward-looking statements include, but are not limited to, risks related to the ongoing impact of the COVID-19 pandemic and those discussed in the Company’s Annual Report for the year ended December 31, 2019 filed with the Securities and Exchange Commission (“SEC”), in subsequent Quarterly Reports on Form 10-Q and in other filings and furnishings made by the Company with the SEC from time to time. Other unknown or unpredictable factors could also have material adverse effects on the Company’s performance. As a result of these or other factors, the Company’s actual results may differ materially from those contemplated by the forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof and are not a guarantee of future performance. The Company undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.