| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Paul Glaeser |
| Created: | 08.08.2017 |
| Modified: | 14.09.2017 15:20:45 |
| Diagram Elements : |
|
|
|
EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485 Anforderungen
- 3 Begriffe
- 4 Qualitätsmanagementsystem
- 5 Verantwortung der Leitung
- 6 Management von Ressourcen
- 7 Produktrealisierung
- 8 Messung, Analyse und Verbesserung
- 8 Messung, Analyse und Verbesserung
- 8.1 Allgemeines
- 8.2 Überwachung und Messung
- 8.3 Lenkung nichtkonformer Produkte
- 8.4 Datenanalyse
- 8.5 Verbesserung
- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox