No | Section title | Number of possible Points | % |
---|---|---|---|
Section 1 | Instructions for use | - | N/Aa |
Section 2 | References | - | N/A |
Section 3 | Registration for a quality program and certification | 7 | 4.2 |
Section 4 | Documents and records | 14 | 8.5 |
Section 5 | Quality assurance | 23 | 13.9 |
Section 6 | Material and product | 16 | 9.7 |
Section 7 | Internal Quality Control | 18 | 10.9 |
Section 8 | Management of staff competencies | 11 | 6.7 |
Section 9 | Failure analysis, problem resolution and root cause analysis | 4 | 2.4 |
Section 10 | External Quality Assessment (EQAb) | 11 | 6.7 |
Section 11 | Storage of antibiotic discs | 12 | 7.3 |
Section 12 | Biosafety | 27 | 16.4 |
Section 13 | Analytical step for the ASTc | 22 | 13.3 |
Overall score | 165 | 100 |