We are pleased to advise you that as of October 2017, our new Minnesota facility is now ISO 13485:2003 compliant and our certification is in place. Over the last year, our Quality team has diligently been working to bring their facility into compliance with ISO regulatory standards. As you may already know, manufacturers in the medical device space are required to have this designation, as part of their regular business practice, thus signifying that their Quality Management System conforms to internationally recognized quality practices related to the design and manufacture of medical devices. Such a system assures that medical devices are designed and produced to the highest standards. Learn More
With a recent acquisition, a new building and an influx of new staff, our Minnesota facility has seen an increase in growth and it became necessary for the Quality team to revamp its Quality Management System so that it was in line with current regulatory standards. Fred Mades, Director of Quality for Biomerics, and his amazing team put in the long hours needed to bring the Minnesota facility into compliance and ensure that their facility had a robust quality management system in place that reflected all of these new changes. I recently talked with Fred, to learn more about his experience with this endeavor, and what he and his team learned from the year-long process. Here are some excerpts from that conversation.
What was your biggest challenge during this process?
One of the biggest challenges during this process was taking the “Standard Operating Procedures” or SOPs from the previously acquired company, reviewing each practice, and determining if that SOP would or wouldn’t fit into our current operations. Using a GAP analysis approach, we determined the items that needed to be addressed and how it would contribute to compliance with regulatory standards. We essentially created a completely new Quality Management System based on 40+ new or revised SOPs.
Another piece of the process was being able to manage all of this, on top of the increased growth that Biomerics was experiencing as we doubled our facility space in our new building, and doubled the increased staff base. The challenge came in being able to manage that growth effectively while at the same time introducing any new or updated quality measures that had to be implemented.
Why was this process important for Biomerics?
As a contract manufacturer, this process was important, first, because of the regulations put in place by the FDA and international regulatory bodies. Secondly, being a certified ISO facility is something our customers require us to have, because of the assurance it brings knowing that we have been “put to the test” in designing and producing quality products and services.
It really helps our customers know and understand that we comprehend the entire process when it comes to designing and manufacturing a medical device and the development of associated technologies. Having this certification is essential as it is part of the approval process for customers who are looking to engage with a medical device contract manufacturer. This is really just the baseline or starting place for our customers. It gives them a level of confidence that we have the experience, knowledge, and capabilities to function as an integral part of their business. Knowing that we are able to manufacture products under a certified quality system, with the appropriate checks and balances, assures them that they will receive a product of the highest quality possible.
What did Biomerics learn through this process?
One of the biggest things we learned that came out of this review process was becoming aware of the need to have a more rigorous approach in place to thoroughly evaluate our SOP’s, Quality Management System, and our suppliers. We were able to evaluate the potential risks and hazards currently in place, resulting in the creation/revision of processes to manage all of the risks appropriately. It also enabled us to streamline our distribution process and find ways to improve a variety of sub-systems that feed up into the larger, over-arching Quality System.
Knowing that ISO 13485:2016 standards are in place, it was determined that based on the position of Biomerics, and the acquisition of the previous company, gaining the 2003 certification would prepare us and put us in a good position to move forward with future iterations of the ISO standard. ISO 13485:2016 is on our radar, and will be something we will be working on in the coming months.
What is the value of this certification?
The value of having this certification allows us to provide enhanced efficiency and an assurance of quality in the design and manufacturing of our customers’ products. As stated before, it is a benchmark that our customers use in their evaluation and selection of a medical device contract manufacturer. As a contract supplier in the medical device arena we are classified in our customer’s quality systems as a critical manufacturer, and as such our customers are also subject to the scrutiny of the FDA and international regulatory bodies. It then is essential that we hold and maintain our certification to the benefit of our customers.
