Collaboration Builds Business Relationships: ISO 13485 Standards Adoption

by Nancy Cates, contributing writer
Plastics Business

Representatives of Currier Plastics visit managers from Cook Group in Bloomington, Indiana, to discuss implementation of ISO 13485.

When Currier Plastics started looking for help in understanding the pros and cons associated with adopting current ISO 13485 standards and registration, company managers sought assistance from MAPP.

The company, founded by Raymond Currier in 1982, has grown to provide design, blow and injection molding operations for its customers. It has been named the Atlantic Region Winner by the Association of Manufacturing Excellence (AME).

Currier’s interest in becoming compliant with ISO 13485 stemmed from a decision to expand the company’s business focus, according to Sriraj Patel, director of research and development at the Auburn, New York, company.

“We decided we wanted to take operations to the next level and expand into the packaging realm of manufacturing in the medical market,” Patel said. “Not all consumable users in the healthcare market require ISO 13485 registration – and we’ve actually been working with some businesses that didn’t require it – but it was determined by the executive committee that it was in our best interest to have that registration.”

According to the website of the International Organization for Standardization (ISO), the worldwide federation uses the work of technical committees to create standards – in the case of 13485:2016, quality management for medical devices. It sets standards for quality management and documentation, management responsibility, resource management, product realization and, finally, measurement, analysis and improvement.

Patel, whose team is responsible for maintaining quality assurance, was tasked with preparing for ISO 13485 certification and registration. The team contacted other local businesses it knew were certified but found only limited interest in a collaborative relationship.

“Time was ticking,” Patel continued, “so we reached out to the larger group through the MAPP website forums and got some feedback. Then John Currier ended up reaching out directly to Troy Nix at MAPP. We knew there were several companies associated with MAPP that were 13485-registered and that we were not in the same form of processing, so John asked if Troy would help make the connection.”

Nix, executive director at MAPP, approached several member companies, and most were responsive, Patel said, but were limited in terms of opening their doors to a visit. After some initial conversations, Nate Myers, general manager of Cook Group, responded positively, with the understanding that Currier was not a competitor.

Cook Group, based in Bloomington, Indiana, began in 1963 as a small company that manufactured simple medical devices. From there it has grown into a corporation with global reach, offering a host of medical devices, as well as life sciences products and such diverse services as property and resort management.

The groups from Currier and Cook had an initial phone meeting to discuss what each hoped to learn and share, and to provide background.

“Cook is a proprietary company,” Patel explained, “and within the Cook Group they have their own molding division, which is where we visited. That began the collaboration. They opened their doors as they were going through their own transition last year, updating ISO 13485:2008 standards to 2016 standards, and the timing was just right. Visiting from our group were Plant Manager Steve Salls, Technical Manager Dustin Dreese and Quality Manager Tim Walawender.

“Our goal was to get a deeper understanding of how the regulations of ISO 13485 differed from ISO 9001 and what that would mean to our organization,” Patel said. “We wanted to get through their facility and see what they were doing differently, based on what the new standard required. We wanted to get a deeper understanding of not only how they complied with the standard but also how they showed evidence of compliance.”

Cook does injection molding as well as extrusion of tubing. “For us, that part aligns,” Patel said. “We do injection molding as well as extrusion and injection stretch blow molding. There was no threat of direct competition, but the comparison was apples to apples in that respect – with the exception that their parent company does design. In the manufacturing group, they were design-excluded, and we also were looking for the design exclusion in our 13485 registration. Most OEMs own the design and rely on the contract manufacturer for input related to design for manufacturability, which is one of our core competencies.

“They were very open to continual help if we need it,” he continued. “I know they were going through re-registration and updating compliance to 2016 from the previous version of ISO 13485, and they also are working on implementation of a new enterprise resource planning (ERP) system. We talked about the differences in our businesses: They are a proprietary molder vs. us being a custom molder. Our businesses definitely operate differently in terms of demands: external vs. internal customers. Although we were doing similar things, we were doing them for different types of customers, with a different impact on our business models.”

After the meeting, Currier determined it would be best to consider either hiring another resource to manage implementation or contract it out. After meeting with consultants, Currier executives were uncomfortable with using a consultancy contract for such a large endeavor, so they decided to add resources to do it internally.

“We had a couple of follow-up conversations with Nate,” Patel said, “touching base to see how their implementation was going and how he felt about managing it internally vs. contracting it out. That helped us decide to stay with the path of doing it on our own.”

The two groups kept in touch after the initial meeting. “We went over things like software validation and some questions as to the depth of what was required – things that needed to be done to satisfy the certification,” Patel said. “Some elements don’t have a real impact on our business, but the standard calls for it, so we do it. The questions sometimes related to how far we should go with a particular requirement: The nth degree? Or leave it as simple as possible?”

Feedback included sharing some of the Cook Group’s experiences with implementation as well as some more extensive and deeper approaches that Cook had taken because they worked better for their business, but weren’t necessarily required by the standard. They also discussed the plusses and minuses of diving right in and getting straight into the process vs. attempting to plan a “perfect” system.

Patel said, “We were interested in the ways they communicated the information and the documentation with the evidence that complies with the standards: forms, management of records, signatures, things like that.”

Currier had been ISO 9001:2008 registered until 2015, and had continued operating under that system, but without continuing the registration. Because of that, Patel said, Currier’s gap and change wasn’t a significant one. “After an extensive search, we hired a key individual to train as an auditor for 13485, and we selected a party to handle our registration. We had done our own gap analysis but wanted to see how that compared with a third-party analysis.

“We’ve been working at the process since then,” Patel continued. “Our Phase 1 audit is coming up soon. From there, we will be working to implement procedural changes and undergo our minimum 90-day evaluation before we go into our registration audit.”

Currier executives are pleased with progress made as a result of collaborating with Cook Group, and Nix was happy that MAPP helped make the connection. “Nate reported to me that it (their meeting) was a very good day, and that both organizations had great takeaways,” Nix said. “I’m pumped about this small but powerful story, as this is MAPP in action.””

In terms of lessons learned, Patel said, “If anything, I think that a greater reach of understanding would have helped – having as many people as possible involved in the process from the beginning so they understood their part. Sometimes I wish we could have brought in someone who had already done it, but I don’t know if that would have benefited the organization as much as what we ended up having to do. It did require the involvement of many more people, and it means we have a much better understanding throughout the organization than we would have if we had hired one person who knew exactly what to do to satisfy the requirement, as each auditor is different. From a timing perspective, hiring someone with experience in implementation of this standard might have been faster, but I don’t think it would have been as effective as what we are doing.”

What advice would Patel give others interested in implementing updated standards? “Network as much as you possibly can,” he advised. “Some of our customers are 13485-registered themselves. They have been of great help in moving this forward. While our customers didn’t demand compliance, it was in the best interest of our business and our customers’ businesses to make it standard practice for us.”