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ISO 13485:2016 | AS9100D | | ITAR | FDA Registered

September 10, 2022
1 min read time

We earned our ISO 13485 Certification for Medical Device Manufacturing

Hirsh achieves ISO 13485:2016 certification graphic

We have earned our ISO 13485:2016 certification! Earning this certification for manufacturing medical devices shows the strength, maturity, and reliability of Hirsh’s quality systems.

We always want to improve our ability to help customers succeed.  Even in times of uncertainty, customers expect us to deliver quality work on time.  We take our commitments seriously, so we created a quality management system.  It formalizes the Hirsh Precision processes that we know add value for our customers.  

Tprepare for this ISO certification, we reviewed our quality management system for opportunities to improve. We named the new version the Hirsh Production System (HPS).  

The HPS represents our latest thinking about how we can best support our customers. It aligns with the early ideas that established Hirsh as a quality brand in 1979 and builds on the framework used for our ISO 9001:2015 certification.  

The Hirsh Production System provides governance required by the ISO 13485 standard, but it is not the only reason for our success. We invest in modern machines, improve our proprietary software and, most of all, empower our team. As a result, we can provide prompt, outstanding customer service.