| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 03.03.2015 23:32:29 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.2 Policy |
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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
- 5 Leadership
- 5.1 Leadership and comittment
- 5.2 Policy
5.2 Policy
«Functional» 5.2 a) Policy shall be appropriate- «Functional» 5.2 b) Policy shall include informaton security objectives
- «Functional» 5.2 c) Policy shall include a commitment to satisfy reqirements related to information security
- «Functional» 5.2 d) Policy shall include a commitment to continual improvement of the ISMS
- «Functional» 5.2 e) Policy shall be available as documented information
- «Functional» 5.2 g) Policy shall be available to interested parties
- «Functional» 5.2. f) Policy shall be communicated
- 5.3 Organisational roles, responsibilities and authorities
- 6 Planning
- 7 Support
- 8 Operation
- 9 Performance evaluation
- 10 Improvement
- IEC 60601-1 Processes
- Sandbox