| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 31.03.2014 14:40:49 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 6.1 * Establish software maintenance plan |
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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
- 6 Software maintenance process
- 6.1 * Establish software maintenance plan
6.1 * Establish software maintenance plan
«Functional» 6.1 a) Procedures for receiving, documenting, evaluating, resolving and tracking arising after release- «Functional» 6.1 b) Criteria for determining whether feedback is considered to be a problem
- «Functional» 6.1 c) Plan shall address the use of the software risk management process
- «Functional» 6.1 d) Plan shall address the use of the software problem resolution process
- «Functional» 6.1 e) Plan shall address the use of the software configuration management process
- «Functional» 6.1 f) Plan shall addres the procedures to evaluate and implement upgrades, bug fixes, patches and obsolences of SOUP
- 6.2 * Problem and modification analysis
- 6.3 Modification implementation
- 7 * Software RISK MANAGEMENT PROCESS
- 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