Quality

ISO 13485 and ISO 9001 Certified Quality Management System

Centex's quality management system operates under the most stringent operating principles available – performing to ISO 13485 and ISO 9001 international quality standards, and FDA regulations, including cGMP.

That's meant a big investment in both equipment and professional personnel, but it also means our processes are proven and repeatable, our inspections are precise, and our products meet our client's requirements every time.
Our ISO certificates are available upon request.

  • Control Plans
  • Validations
  • Fully Documented QMS
  • PFMEA's
  • Risk Assessments/Analysis
  • Controlled Inspection Documents
  • Data Collection and analysis
  • Internal Audits
  • CAPA
  • Customer Complaints