Quality

Ambrit Engineering’s Quality Team has extensive experience manufacturing components and subassemblies for healthcare (diagnostics, medical devices, drug delivery systems, surgical tools), aerospace, commercial, and consumer goods.  Using a wide range of methods and tools, Ambrit supports the Quality System with Tooling Engineering, Process Development, Mold Qualification, Process Validation, and Risk Management.

Ambrit Engineering has established, documented, and implemented a superior Quality Management System.  Our QMS is routinely audited by clients and notified bodies for effectiveness in accordance with ISO 13485 and ISO 9001 standards.

Our Commitment to Quality includes:

  • ISO 13485 Certification
  • ISO 9001 Certification
  • ISO Class 8 Cleanroom
  • All employees trained on Good Manufacturing Practice (GMP)
  • Lean Manufacturing deployed to minimize processing waste and improve part quality
  • Test method development, first article inspections, Gauge R&R
  • EIQ software from IQMS with six modules of QMS to manage electronic records