Quality

When 70% of your business is with the medical industry, tight quality standards are a given.

Totex’s quality system has been shaped by many years of experience and the large number of medical device customers we have. As you might imagine, there is very high liability potential in the medical device industry so catastrophic failures in the hands of an end user is not an option. To make the millions of batteries that we have without a manufacturer-caused catastrophic failure in the field is a testament to how ingrained quality is in Totex employees and processes.

 
 
 

Certifications and Compliance

  • ISO 9001
  • ISO 13485
  • ISO 14001
  • FDA Registered line
  • QC 08000
  • IPC610D
  • REACH
  • WEEE
  • RoHS
  • Conflict minerals, EICC / GeSI
  • Class 9 Dangerous Goods

Other Quality Controls

  • FMEA, MTBF, DVT plans
  • Microscopic visual inspection of all SMT solder points
  • Statistical Process Control on all major assembly processes
  • Real-time line failure monitoring
  • Pre-ship burn-in testing
  • 800 burn-in channels for pre-ship battery cycling
 
SARA Quality Certificate
ISO 1400 Certificate