QUALITY

Tissue Source is focused not only on product quality and service quality, but also finding ways to meet or exceed those expectations through continuous improvement. Tissue Source has developed a Quality Management System to meet the regulations for the medical research and medical device industry.

 

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 Requests
  6. Risk Management / FMEA
  7. Training
  8. Preventive Maintenance (PM)
  9. Calibration
  10. Supplier Evaluations
  11. Customer Surveys/Feedback
  12. Supplier Surveys