| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 31.03.2014 15:27:56 |
| Modified: | 02.01.2015 01:07:22 |
| Diagram Elements : |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62304 Software
- 3 Terms and definitions
- 4 General requirements
- 5 Software development process
- 6 Software maintenance process
- 7 * Software RISK MANAGEMENT PROCESS
- 7 * Software RISK MANAGEMENT PROCESS
- 7.1 * Analysis of software contributing to hazardous situations
- 7.2 Risk control measures
- 7.3 Verification of risk control measures
- 7.3 Verification of risk control measures
- 7.3.1 Verify RISK CONTROL measures
- 7.3.2 Document any new sequences of events
- 7.3.3 Document TRACEABILITY
7.3.3 Document TRACEABILITY
«Functional» 7.3.3 a) from the hazarduous situatio to the software item- «Functional» 7.3.3 b) from the software item to the specific software cause
- «Functional» 7.3.3 c) from the software cause to the risk control measure
- «Functional» 7.3.3 d) from the risk control measure to the verification of the risk control measure
- 7.4 Risik management of software changes
- 8 Software configuration management process
- 9 * Software problem resolution PROCESS
- 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