QUALITY

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.

 

Regulatory Standards

  1. ISO 13485 certified
  2. ISO 9001 certified
  3. ISO 22442-2 compliant
  4. USDA Class A Breeder
  5. USDA HACCP System
  6. FDA 21 CFR 820 compliant
  7. FDA 21 CFR 589 compliant
  8. UL Registered Firm   








     

Quality Control

  1. Annual Farm audits
  2. Annual Abattoir audits
  3. Controlled feed system
  4. Ante and Post-Mortem Inspection
  5. Risk assessment on farms
  6. Risk assessment on abattoirs
  7. Bio Security process in place for farms
  8. Qualified USDA Abattoir
  9. Traceability of animals and tissues
  10. Verification of customer specifications
  11. Environmental monitoring

Quality Assurance

  1. CAPA
  2. Deviation
  3. Non-Conformance
  4. Document Control
  5. Change Control
  6. Risk Management / FMEA
  7. Training
  8. Preventive Maintenance (PM)
  9. Calibration
  10. Supplier Evaluations
  11. Customer Surveys/Feedback