Quality Systems - Global Quality in Systems - and Practice

A high level of collaboration and strong, responsive culture are required for successful development and production of customers' components, assemblies and devices. Heraeus has implemented quality objectives to provide products and services that exceed customers' expectations by:

  • Ensuring only high-quality product is shipped to customers
  • Continuous improvement in delivery performance
  • Regulatory compliance
  • Maintenance and continuation of ISO certifications

Quality:  Heraeus Medical Components

Our approach to quality includes a Global Quality Manual covering all locations in Germany, USA, Switzerland, Puerto Rico, Costa Rica, and Singapore. Each manufacturing site carries its own certification to appropriate ISO standards.

The use of GHTF (Global Harmonization Task Force) Guidelines for compliance ensures robustness and alignment with customers.

The following sites are FDA registered:

  • Plymouth, USA
  • San Rafael Alajuela San Jose, Costa Rica
  • Dorado, Puerto Rico
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