In April 2024, Reata Engineering achieved ISO 13485:2016 certification. This certification establishes a stringent international standard for medical device quality management systems and serves as proof of our consistent, high-quality production process.
ISO 13485 is a rare certification for precision machine shops to maintain due to the high costs of annual audits. However, we knew it was a worthwhile investment because over 70% of our customers are in the medical industry.
We’re committed to upholding our ISO 13485 certification because it proves our capabilities and confirms our high-quality parts and rigorous processes. Seeing the ISO 13485 badge on our website assures customers and stakeholders of our commitment to excellence.
And when they see their finished parts, they’ll know for sure.
How Customers Benefit from ISO 13485 Certification
As a leading precision machine shop, Reata already had many processes in place for ISO 13485 certification. So why did we invest tens of thousands of dollars into a piece of paper that proves it?
Because our customers will benefit.
At the heart of ISO 13485 certification lies the assurance of consistent and reliable production. Maintaining compliance requires annual and internal audits, and customers benefit from the constant improvement and adjustments resulting from regular third-party assessments.
In addition to the accountability and quality benefits, there are three specific advantages associated with ISO 13485:
- Meticulous lot traceability
- Structured business operations
- Adherence to industry best practices
These elements enhance product quality for every customer and instill confidence that Reata is committed to producing the highest quality parts. We’re proud to be a precision machine shop that continues to seek improvement to benefit medical customers and the industry’s innovation.
How medical customers benefit
Our new certification predominantly impacts the manufacturing of medical devices such as surgical tools and medical machines. For example, the customer behind the advanced surgical retractor systems we produced began to require ISO 13485 certification to verify impeccable quality for a product with such a critical and potentially life-saving end-use.
Our customer base has expanded, enabling us to bring our expertise to more life-saving projects. With this new certification, Reata’s top-level services are available to medical device companies and government contractors who require suppliers to have ISO 13485 certification.
Why Reata Took the Leap to Certification
Attaining ISO 13485 certification was a no-brainer for Reata. The requirements align closely with practices deeply ingrained in Reata’s culture, like a commitment to manufacturing high-quality parts and conducting rigorous inspections. It fits as a natural extension to our current quality management systems.
However, obtaining ISO 13485 certification can be daunting, especially for companies unaccustomed to maintaining such rigorous standards. The financial burden associated with annual audits and internal compliance measures can range from $30,000 to $50,000, necessitating careful budgeting and resource allocation.
But the investment in elevating quality standards across the company is invaluable.
ISO 13485 certification enhances Reata’s reputation as a leader in medical device manufacturing and sets a precedent for excellence within the industry. As more companies strive to meet these standards, the collective impact on product quality and patient safety is immeasurable.
And to us, that’s the most significant success of all.
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