| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 11.03.2014 12:52:26 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 3.1 Risk management process |
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Overview- Organisation Chart
- Staff
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- SOPs
- Templates
- Software tools
- Equipment
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- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- ISO 14971 Requirements
- 2 Terms an definitions
- 3. General requirements for risk management
- 3. General requirements for risk management
- 3.1 Risk management process
3.1 Risk management process
«Functional» 3.1 Risik analysis- «Functional» 3.1 Risk evaluation
- «Functional» 3.1 Risk control
- «Functional» 3.1 Production and post-production information
- «Functional» 3.1 Product realization process shall incorporate appropriate parts of the risk management process
«document» Figure 1: A schematic representation of the risk management process
- 3.2 Management responsibilities
- 3.3 Qualification or personnel
- 3.4 Risk management plan
- 3.5 Risk management file
- 4. Risk analysis
- 5. Risk evaluation
- 6. Risk control
- 7. Evaluation of overall residual risk acceptability
- 8. Risk management report
- 9. Production and post-production information
- Anhang ZA
- 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