What ISO 13485:2016 Certification Means for a Manufacturer

Written by John Flynn

At Extreme Molding, we pride ourselves on delivering high-quality, reliable products to our customers. That’s why we’re excited to share that we’ve now achieved ISO 13485:2016 certification – a globally recognized standard for quality management systems in the medical device industry. 

In this post, we’ll explore what ISO 13485:2016 certification means, why it matters for medical devices, and how this certification benefits customers.

What is ISO 13485:2016 Certification?

ISO 13485:2016 sets the international standards for quality management systems in the design and production of medical devices. This certification ensures that manufacturers meet rigorous regulatory and customer expectations for designing, producing, and distributing medical devices and related services.

Being ISO 13485 certified shows customers and regulatory bodies that a company has a solid and reliable system in place to ensure safety, quality, and compliance throughout every stage of production.

Why is ISO 13485 Certification Important for Medical Devices?

Medical devices must adhere to strict safety and reliability standards because they directly impact patient health. ISO 13485 certification provides a robust framework for quality management, ensuring that every product meets specific industry regulations and customer expectations.

For customers, working with an ISO 13485 certified manufacturer provides peace of mind. It demonstrates that the manufacturer has implemented processes to reduce risks, improve efficiency, and consistently deliver products of the highest quality.

Why Did We Pursue ISO 13485:2016 Certification?

Our goal was to enhance our commitment to serving industries like healthcare, where safety and reliability are non-negotiable. With that in mind, we recognized the growing importance of ISO 13485:2016 certification. As an FDA registered facility, we were aware that the FDA will soon require all registered facilities to achieve ISO 13485:2016 certification. We made the decision to pursue certification ahead of the upcoming directive.

Additionally, achieving this certification allows us to expand our capabilities. Previously, we received inquiries for medical device manufacturing that required ISO 13485:2016 certification—projects we couldn’t take on. Since announcing our certification, we’ve already received a half-dozen inquiries, showcasing the growing demand for ISO-certified manufacturers. 

What Was the Process of Obtaining ISO 13485:2016 Certification Like?

Obtaining ISO 13485:2016 certification required an in-depth evaluation of our existing quality management systems. This process included:

1. Gap Analysis: Assessing our current practices against ISO 13485 requirements to identify areas for improvement - we performed a GAP analysis to highlight where we needed to update our QMS.  This included an in-depth review of our Quality Manual and each Quality procedure to ensure it was compliant with both standards. There were several new procedures introduced to meet the specific requirements of ISO 13485:2016.
2. Process Optimization: Enhancing workflows and documentation to align with the standard.
3. Training: Educating our team on the requirements and their role in upholding quality standards.
4. Audits: Conducting internal and external audits to verify compliance and readiness for certification.

In total, the ISO 13485 certification process took about a year from start to finish. Achieving this certification demanded commitment, collaboration, and a focus on maintaining the highest standards at every stage of production.

What Challenges Did We Face During The Certification Process?

Achieving ISO 13485:2016 certification was no small feat. Integrating its requirement with our existing ISO 9001:2015 QMS was a significant challenge, as each standard has unique requirements. In addition to this, we also introduced new procedures and enhanced existing ones to ensure full compliance.

What’s Next For Extreme Molding Now That We’ve Achieved Certification?

While there are no immediate plans to pursue additional certifications, we remain open to exploring new opportunities if they align with market demand and strategic goals. It always depends on the market conditions. If opportunities arise that require us to have a different or new certification, we will review them and evaluate it to see if it fits with our strategic direction and makes good business sense. 

How Does ISO 13485 Certification Benefit Extreme Molding’s Customers?

Whether you’re sourcing medical-grade silicone components or other high-performance products, our ISO 13485 certification ensures you can trust Extreme Molding to deliver.

For our customers, this certification offers several key benefits:

• Regulatory Compliance: Demonstrated compliance with international regulatory requirements for medical devices, simplifying market entry in regions like the EU, U.S., and other countries that recognize ISO 13485.
• Enhanced Product Quality: With our combined 13485:2016 and 9001:2015 Quality Management System (QMS), we ensure consistent, high-quality production required for medical devices.
• Competitive Advantage: As manufacturing shifts back to the U.S., we offer MADE IN THE USA products that set your business apart in today’s market.

Committed to Excellence

Achieving ISO 13485:2016 certification is more than a milestone for Extreme Molding—it’s a reflection of our dedication to quality, innovation, and customer satisfaction. By aligning our practices with this global standard, we’re better equipped than ever to meet the needs of our customers in the medical, healthcare, and consumer industries.

Ready to partner with an ISO 13485-certified manufacturer? Contact us today to learn more about how we can support your next project.