| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 07.03.2014 12:50:33 |
| Modified: | 28.11.2014 00:51:50 |
| 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
- 6 Resource management
- 7 Product realization
- 8 Measurement, analysis and improvement
- 8 Measurement, analysis and improvement
- 8.1 General
- 8.2 Monitoring and measurement
- 8.3 Control of nonconforming product
- 8.4 Analysis of data
8.4 Analysis of data
«Functional» 8.4 Determine, collect and analyse data to demonstrate the suitability and effectiveness of the QMS- «Functional» 8.4 a) Feedback
- «Functional» 8.4 b) Conformity to product requirements
- «Functional» 8.4 c) Process characteristics and trends including opportunities for preventive actions
- «Functional» 8.4 d) Suppliers
- 8.5 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