ISO 13485:2003 and ISO 9001:2008

Utitec, Inc
169 Callender Road
PO Box 370
Watertown, CT 06795
Phone: (860) 945-0601
Email: sales@utitec.com


ISO 13485:2003 and ISO 9001:2008
FDA Registration Number: 3014032451

Utitec, Medical SA
Zona Franca Coyol
Building B-15
El Coyol de Alajuela
Costa Rica - Central America
P (506) 2429-2000 F (506) 2429-2016
Email: sales@utitec.com


Quality System

Creating high quality and customer loyalty, UTITEC's Quality Management System is certified to ISO 13485:2003, which is the global standard for Medical Devices. A directive and requirement by our medical customers, we maintain a leadership advantage in application and quality control management that has no margin for error. UTITEC has maintained approved supplier status with leading companies in the medical device, electronics, consumer market and industrial application fields - some for decades.

Inspection Technologies
  • Computerized Vision based Inspection Technologies 
  • CMM with scanning and touch probing capability 
  • Laboratory for determining metallurgical properties 
  • Laser micrometry 
  • Smartscope 
  • Surface Finish Measurement 
  • SPC for real-time process control

ISO Certification:
  • ISO 13485:2003
  • ISO 9001:2008
  • Registrar: TUV

SPC:
  • ASI Datamyte SPC Software/hardware. 
  • CTQ (Critical to Quality features controlled to 1.33 Cpk or higher)

Inspection Practices: 
  • First Article after all set-ups and material lot changes 
  • In-process inspections performed by operators and inspectors 
  • Final Inspection 
  • (5) Full-time Inspectors 
  • Six Sigma Trained

Integrated NPI (New Product Introduction) process:
  • Design for Manufacturability
  • Risk based process design
  • Process capability determination and control
  • Gage capability analysis and determination
  • Validation ? IQ/OQ/PQ 
  • Process/Production Control Plan
  • Full PPAP qualification process.

Equipment:
  • CMM 
  • Optical Comparators 
  • Smart Scopes 
  • Rockwell Hardness Tester 
  • Clark Micro Hardness Tester