Mack Molding recently announced that is has started the process of systematizing ISO 9001:2015 and ISO 13485:2016 fifth and third revisions for medical devices.
The company plans to train internal auditors to help assure that Mack Molding is ready to be certified after audits that are scheduled for July.
“When we first implemented ISO 9001 in 1990, we were one of a handful of injection molders to do so,” Jeff Somple, Mack Molding president, said. “It was a great selling point at the time, but today it is a necessity – a license to do business in the highly technical markets we serve. In the early 2000s, we implemented ISO 13485 to gain access to the medical device industry, and as a result, today we are a stronger, more diverse organization. It has proven to be a competitive advantage for Mack, and the good news is we are already doing most of what the new standards require.”
Part of the new ISO standards is based on risk management and making sure employees are on track with organizational goals.
“We are well on our way to achieving what ISO, and many of our customers, are looking for,” Somple said. “It goes far beyond what most organizations would consider for a quality management system, emphasizing the management piece in ways that have already proven to be our strength. Risk-based thinking is a critical part of engineering, however, we cannot rest on our laurels. That is why Mack is committing the resources and the time to get it right.”
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