JBC Technologies Receives ISO 13485:2016 Certification

JBC Technologies was founded on three main pillars: supply chain optimization, engineering innovation, and manufacturing excellence. Quality is very important to us and our many customers in the medical industry, which is why we are excited to announce that our Elk Grove, IL center of excellence has achieved ISO 13485:2016 accreditation!

What is ISO 13485:2016?

ISO 13485 is an essential certification for those involved in the design, production, installation, and servicing of medical devices that puts emphasis on rigorous risk management and decision-making processes throughout the many phases of a product's life cycle. Adhering to agreed-upon international standards for a quality management system (QMS), ISO 13485 ensures that even the most stringent quality standards and regulations within the medical industry are met every step of the way. To achieve this accreditation JBC underwent a rigorous audit process that included a review of its current QMS, processes, procedures, and ability to meet customer and regulatory requirements.

"Attaining our ISO 13485 certification positions JBC very well to continue our strong growth in medical device components, wearables, dressings and wound care, and diagnostics. It is a formal recognition of our continued organizational focus on quality and culture of continuous improvement that will help us strengthen our position as a trusted and reliable partner for medical applications worldwide." - Todd Wright, CEO of JBC Technologies

So, what does this mean for JBC and more importantly... you?

Although not a mandatory certification, becoming ISO 13485 certified is just one of the many ways JBC solidifies our commitment to our foundational pillar of manufacturing excellence through high-quality die-cut solutions. We understand that maintaining a QMS is an important step in exceeding the quality expectations of our customers day in and day out. Displaying the ISO 13485 badge shows that we are willing to do what it takes throughout every step of the manufacturing process to bring you the high-quality custom-engineered product you need.    As a customer, ISO 13485 certification provides unparalleled assurance that the converting partner you select is committed to quality and regulatory compliance, continuous improvement, and manufacturing excellence.

The Importance of an ISO 13485 Certified Converting Partner

With over 35 years of experience converting rolls of flexible material into custom die-cut parts, JBC Technologies is your go-to medical converting partner. With multiple ISO Class 8 cleanrooms, JBC provides custom-engineered solutions for wearable medical device components, dressings and wound care, stick-to-skin disposable medical devices, diagnostics, and many other contract medical manufacturing applications. Contact us today to get started on your next custom medical die-cutting project. 

View JBC Technologies' ISO 13485:2016 Certification here.