As part of its commitment to expand into medical molding, New Berlin Plastics recently had a preliminary ISO 13485 audit done by the Wisconsin Manufacturing Extension Partnership (WMEP), a not-for-profit organization that provides consulting services to local manufacturers.
WMEP performs ISO 9001 and ISO 13485 gap assessments for organizations in support of implementation and annual internal audit plans. It also advises manufacturers on the steps they need to take to achieve these certifications. ISO 13485 is a standard defining requirements for processes, documentation, and recordkeeping that’s based on ISO 9001 with additional requirements that are specific to the medical industry.
NBP is already certified to the ISO 9001:2015 standard and complies with the automotive industry’s quality management system IATF 16949 when specified by customers. NBP’s new product development (NPD) process is based on the Automotive Industry Action Group’s (AIAG) Advanced Product Quality Planning (APQP) methodology, and Production Part Approval Process (PPAP).
“Any manufacturer that serves the automotive industry and any others that are closely related to it – such as motorcycles, recreational vehicles, and aerospace – know and recognize APQP,” explains Vice-President of Sales Joseph Mechery. “When we’re talking to an OEM and they learn that we use APQP as the basis for our NPD process, it immediately gives them confidence that we have the processes, documentation, and training that enable us to develop and manufacture parts at a very high level of quality.”
Advantages of independent audits
New Berlin Plastics uses WMEP to perform periodic independent audits to uncover opportunities for improvement or areas of non-conformance.
“Some companies audit themselves, but we found that didn’t work as well as using an independent resource,” points out President Jim Schneberger. “WMEP not only conducts these assessments but they also bring a critically important third-party perspective to us. Because they audit so many types of businesses, they often recommend changes or approaches that have worked for other companies that we might not have thought of.”
Most importantly, conducting independent audits throughout the year enables the NBP quality team to develop a project map – an action plan to close any gaps they uncover so the company can be fully prepared for the official audit and to provide outstanding performance for customers and employees.
Results of the WMEP audit
WMEP’s recent ISO 13485 gap assessment revealed that New Berlin Plastics already meets most of the requirements of the standard. NBP’s quality team is now working on the next steps to address the handful of gaps that were identified.
Schneberger indicated that New Berlin Plastics may add a resource to its quality department who has experience with ISO 13485 to help accelerate NBP’s efforts to achieve certification. He believes this addition could also help the NBP team understand how medical device OEM engineers think. “We need to understand how to align with their culture and meet their expectations. We need to learn the lingua franca of their world.”
Another possibility is to create a separate business unit that will be devoted to medical device customers. “This would give us a cleaner break between the management systems, processes, and record-keeping that each part of our business will require. It may also make it easier for our employees to understand the expectations of manufacturing medical parts versus non-medical parts.”
Another step in the months ahead will be to select an existing non-medical part to which the NBP team can apply ISO 13485 policies, procedures, and methods.
“We need to do this to build up a body of evidence through documentation and records that a third-party auditor can review. They will then make a recommendation to the registrar whether we should be certified to the standard,” Schneberger points out.
Fortunately, New Berlin Plastics already produces parts that are very similar to those used in out-of-body medical devices – such as bezels for screens and brackets to hold instruments and circuit boards. Thanks to its commitment to APQP, the company is already operating at a very high level of quality with rigorous processes, recordkeeping, and training in place.
“The fundamentals of our business support doing this type of work for medical device manufacturers. We’re already handling projects that require an exceptionally high level of quality, where every part we ship must meet our customers’ requirements 100 percent of the time,” Schneberger emphasizes.
New Berlin Plastics hopes to schedule its ISO 13485 examination for the first quarter of 2024 at the latest.
For more information about New Berlin Plastics’ relevant expertise, visit the Medical Device Resource Center. Contact NBP today to discuss your medical device molding needs.
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