Compliance auditISO 15189:2022
ISO 15189:2022 — Medical laboratories
Requirements for the quality and competence of medical laboratories, covering governance, resources, pre-analytical, analytical and post-analytical processes, and the management system.
- control points
- 59
- anchored clauses
- 30
- Clauses covered
- 7
Clauses covered
| General requirements | 3 | 4.1 · 4.2 · 4.3 |
| Structural and governance requirements | 5 | 5.1 · 5.2 · 5.3 · 5.6 · 5.4-5.5 |
| Resource requirements | 6 | 6.2 · 6.3 · 6.4 · 6.5 · 6.6 · 6.7-6.8 |
| Pre-analytical and post-analytical processes | 2 | 7.2 · 7.4 |
| Analytical processes | 4 | 7.3.6 · 7.3.7 · 7.3.2-7.3.3 · 7.3.4-7.3.5 |
| Control of work, data, complaints and continuity | 4 | 7.5 · 7.6 · 7.7 · 7.8 |
| Management system requirements | 6 | 8.5 · 8.6 · 8.7 · 8.8 · 8.9 · 8.2-8.4 |
Scale
CompliantOpportunity for improvementNon-compliantNot applicable
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