| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 06.03.2014 14:08:05 |
| Modified: | 28.11.2014 00:43:13 |
| Diagram Elements : |
|
|
|
|
|
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
- 6 Resource management
- 6 Resource management
- 6.1 Provision of resources
- 6.2 Human resources
- 6.3 Infrastructure
- 6.4 Work environment
6.4 Work environment
«Functional» 6.4 a) Requirements for health, cleaniness and clothing- «Functional» 6.4 b) Requirements on work environment conditions and documented procedures of work
- «Functional» 6.4 c) Ensure that personnel are appropriatelly trained or supervised
- «Functional» 6.4 d) Establish arrangements for the control of contaminated products
- 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