| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 24.02.2014 15:25:08 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 3. General requirements for risk management |
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Overview- Organisation Chart
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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
- 3.2 Management responsibilities
- 3.3 Qualification or personnel
- 3.4 Risk management plan
3.4 Risk management plan
«Functional» 3.4 A If the plan changes during life-cycle, a record shall be maintained- «Functional» 3.4 a) Scope of the planned risk management activities
- «Functional» 3.4 b) Assignment of responsibilities and authorities
- «Functional» 3.4 c) Requirements for review of risk management activities
- «Functional» 3.4 d) Criteria for risk acceptability
- «Functional» 3.4 e) Verification activities
- «Functional» 3.4 f) Activities related to collection and review of relevant production and post-producton information
«document» Annex D: Figure 4/5: Risk matrix
- 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