| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 04.03.2015 08:03:41 |
| Modified: | 00:00:00 |
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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 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- ISO 27001 Information technology - Security techniques
- 4 Context of the organisation
- 5 Leadership
- 6 Planning
- 6 Planning
- 6.1 Actions to address risks and opportunities
- 6.1 Actions to address risks and opportunities
- 6.1.1 General
6.1.1 General
«Functional» 6.1.1 ISMS can achieve its intended outcome(s)- «Functional» 6.1.1 b) ISMS shall prevent, or reduce, undesired side effects
- «Functional» 6.1.1 c) ISMS shall achieve continual improvement
- «Functional» 6.1.1 d) The organisation shall plan actions to address risks and opportunities
- «Functional» 6.1.1 e1) The organisation shall plan how to integrate actions into its ISMS processes
- «Functional» 6.1.1 e2) The organisation shall plan how to evaluate the effectiveness of these actions.
- 6.1.2 Information security risk assessment
- 6.1.3 Information security risk treatment
- 6.2 Information security objectives and planning to achieve them
- 7 Support
- 8 Operation
- 9 Performance evaluation
- 10 Improvement
- IEC 60601-1 Processes
- Sandbox