Tissue Source is firmly committed to providing products and services that meet or exceed our client’s requirements by maintaining the continued effectiveness of the Quality Management System. The Tissue Source Quality Management System is specifically developed to meet the quality and regulatory expectations of the medical research and medical device fields.



  • ISO 13485 Certified
  • ISO 9001 Certified
  • ISO 22442-2 Compliant
  • FDA 21 CFR 820 Compliant
  • USDA HACCP System
  • USDA-FSIS Inspected Facilities
  • APHIS Chapter 8 Health Certificates for Export to EU

Quality System Elements

  • Procedures for
    • Corrective and Preventive Action (CAPA)
    • Deviations
    • Non-Conformances
    • Document Control
    • Change Control
    • Training
    • Maintenance and Preventive Maintenance
    • Calibratioins
    • Supplier Qualifications
    • Customer Feedback
  • Risk Management program using FMEA
  • Supplier Evaluations performed annually
  • Customer Surveys sent annually