NBP’s ISO 13485 Certification Expands Portfolio in Medical Device Market

As medical device manufacturers continue to diversify their supply base to protect against supply chain challenges, New Berlin Plastics has expanded its reach into the medical device industry. To accommodate these medical manufacturers’ needs, NBP is now ISO 13485 certified, meeting international quality standards for medical device companies.

While NBP continues to diversify its customer portfolio to include the medical device market, the company is still committed to supporting the customers and markets it already serves.

“Our growth plan is to continue expanding into a variety of industries so we can maintain stability during market fluctuations,” says Jim Schneberger, President of NBP. “A more diverse portfolio insulates our company and customers from industry-specific risk, so we continue to be a dependable partner for the long term.”

Medical device parts

NBP has experience producing parts similar those used in medical devices, but the new ISO 13485 certification provides the necessary requirements that many medical device manufacturers need to choose an injection molding partner. NBP has supported the medical industry in the past with parts such as those for medical furniture and IV flow control devices. 

Currently, NBP manufactures parts for markets with medical industry parallels, such as cosmetic parts that require pad printing, furniture/appliance components, and 100% safety critical parts, as well as panels, covers, housings, and mounting boards for electronics.

Certification audit

To receive ISO 13485 certification, NBP underwent a three-day intensive audit conducted by NQA Global Certification Body, a well-respected registrar. Three auditors assessed every aspect of operations to ensure the company’s quality management system ensures regulation compliance and maintains medical patient safety. The audit report indicated no major findings and six minor findings (roughly half of what they normally find at well-performing manufacturing facilities). To address the six minor findings, NBP put corrective actions in place. 

Parallel to the ISO 13485 audit, the company passed its ISO 9001:2015 recertification without any issues. Continued investment in quality management is an ongoing mission to ensure reliable and consistent performance as a manufacturer and supplier. For ISO 13485, NBP spent about a year exploring the certification and completing the due diligence needed to ensure compliance, then making the processes for these standards part of daily operation.

 “We were confident we would be successful with both the ISO 9001:2015 and ISO 13485 audits because we were well prepared,” Schneberger says. “Certification is not just a piece of paper we hang on the wall. Most importantly, the amount of talent and expertise we have across the business provides a competitive edge not only for these audits, but how we perform and support our customers every day.” 

If you’re a medical device manufacturer and want to learn about how we can help you with ISO 13845 certified injection molded parts, please visit our Medical Device Resource Center or contact us today to discuss your needs.