| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 03.03.2015 22:36:17 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 4 Context of the organisation |
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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
- 4 Context of the organisation
- 4.1 Understanding the organisation and its context
- 4.2 Understanding the needs and expectations of external parties
- 4.3 Determine the scope of the information security management system
4.3 Determine the scope of the information security management system
«Functional» 4.3 a) The scope shall consider the external and internal issues referred to in 4.1- «Functional» 4.3 b) The scope shall consider the interfaces and dependencies between activities
- «Functional» 4.3 c) The scope shall consider the requirements referred to in 4.2
- 4.4 Establish, implement and maintain an information security management system
- 5 Leadership
- 6 Planning
- 7 Support
- 8 Operation
- 9 Performance evaluation
- 10 Improvement
- IEC 60601-1 Processes
- Sandbox