IVD

12345678910
Across
  1. 4. System ensuring reliability of diagnostic results
  2. 6. Process confirming a method meets required performance
  3. 7. Established guideline used for testing procedures
  4. 8. Recorded information required for compliance
  5. 9. Ability to track results to reference standards
Down
  1. 1. Adherence to regulatory requirements
  2. 2. Formal recognition of laboratory competence
  3. 3. Confirmation that system performs as expected
  4. 5. Systematic review of processes and records
  5. 10. Quality management standard for medical devices