Mack Molding implementing ISO standards for medical devices

Mack Molding, a custom plastics molder has announced it is gaining ISO 9001:2015 and ISO 13485:2016 of the international standards for general quality management and assurance, as well as for medical devices.

The new standards include areas on risk management and ensuring that employees are aligned with organisational goals, something that aligns with Mack’s strategy for growth, the company states.

Mack Molding president Jeff Somple, said: “When we first implemented ISO 9001 in 1990 we were one of a handful of injection molders to do so. 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.”

Recently, more than 140 members of the company gather to discuss what the new standards mean for Mack and how they will be implemented. The company’s next steps include training internal auditors to help ensure it is ready to become certified following audits scheduled to take place in July.

"We are well on our way to achieving what ISO, and many of our customers, are looking for," Somple added. "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."