Compliance auditISO 13485:2016
ISO 13485:2016 — Medical device QMS
Requirements for the quality management system of an organization involved in the life cycle of medical devices, for regulatory purposes.
- control points
- 55
- anchored clauses
- 30
- Clauses covered
- 5
Clauses covered
| Quality management system | 4 | 4.1 · 4.2.4 · 4.2.5 · 4.2.2-4.2.3 |
| Management responsibility | 4 | 5.5 · 5.6 · 5.1-5.2 · 5.3-5.4 |
| Resource management | 4 | 6.1 · 6.2 · 6.3 · 6.4 |
| Product realization | 10 | 7.1 · 7.2 · 7.3.2-7.3.4 · 7.3.5-7.3.7 · 7.3.8-7.3.10 · 7.4 · 7.5.1-7.5.4 · 7.5.5-7.5.7 · 7.5.8-7.5.11 · 7.6 |
| Measurement, analysis and improvement | 8 | 8.2.1 · 8.2.2 · 8.2.3 · 8.2.4 · 8.2.5-8.2.6 · 8.3 · 8.4 · 8.5.2-8.5.3 |
Scale
CompliantOpportunity for improvementNon-compliantNot applicable
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