Section 1: Documents and Records | 28 |
Section 2: Management Reviews | 14 |
Section 3: Organization and Personnel | 22 |
Section 4: Client Management and Customer Service | 10 |
Section 5: Equipment | 35 |
Section 6: Evaluation and Audits | 15 |
Section 7: Purchasing and Inventory | 24 |
Section 8: Process Control | 32 |
Section 9: Information Management | 21 |
Section 10: Identification of Nonconformities, Corrective, and Preventive Actions | 19 |
Section 11: Occurrence/Incident Management and Process Improvement | 12 |
Section 12: Facilities and Biosafety | 43 |
Total score | 275 |
Level 1 (0–150 pts) <55% | Level 2 (151–177 pts) 55%–64% | Level 3 (178–205 pts) 65%–74% | Level 4 (206–232 pts) 75%–84% | Level 5 (233–260 pts) 85%–94% | Level 6 (261–275 pts) ≥95% |