| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 06.03.2014 12:50:28 |
| Modified: | 06.01.2015 00:30:15 |
| 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 13485 Requirements
- 3 Terms and definitions
- 4 Quality management system
- 5 Management responsibilities
- 5 Management responsibilities
- 5.1 Management commitment
- 5.2 Customer focus
- 5.3 Quality policy
- 5.4 Planning
- 5.5 Responsibility, authority and communication
- 5.5 Responsibility, authority and communication
- 5.5.1 Responsibility and authority
- 5.5.2 Management representative
5.5.2 Management representative
«Functional» 5.5.2 a) shall ensure that QMS processes are established, implemented and maintained- «Functional» 5.5.2 b) shall report to top management on the QMS performance and need for improvement
- «Functional» 5.5.2 c) shall ensure the promotion of regulatory and customer requirements
- 5.5.3 Internal communication
- 5.6 Management review
- 6 Resource management
- 7 Product realization
- 8 Measurement, analysis and improvement
- Annex ZB.2 Relationship with Annex II of MDD 93/42/EEC
- 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
- IEC 60601-1 Processes
- Sandbox