We are ISO 13485 Certified!

We have earned 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.  

We are pleased to share this update with you!  If you would like to learn more, please get in touch using the form at the bottom of this page.  You can also follow us on LinkedIn!