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 9001:2015 + AS9100D and ISO 13485:2016 Certifications.
ISO 13485:2016 Certification
ISO 9001:2015 + AS9100D 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
EnterpriseIQ software from DELMIAWorks with six modules of QMS to manage electronic records