| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Created: | 06.03.2014 11:23:51 |
| Modified: | 17.09.2019 10:36:40 |
| 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
- 4 Quality management system
- 4.1 General requirements
- 4.2 Documentation requirements
- 4.2 Documentation requirements
- 4.2.1 General
4.2.1 General
«Functional» 4.2.1 a) The QMS shall include a quality policy and quality objectives- «Functional» 4.2.1 b) The QMS shall include quality manual
- «Functional» 4.2.1 c) The QMS shall include documented procedures
- «Functional» 4.2.1 d) Ensure the effective planning, operation and control of its processes
- «Functional» 4.2.1 e) The QMS documentation shall include records required
- «Functional» 4.2.1 f) The QMS shall include other documentation specified by national or regional regulations
- «Functional» 4.2.1 File for each type or model of medical device
- 4.2.2 Quality manual
- 4.2.3 Control of documents
- 4.2.4 Control of records
- 5 Management responsibilities
- 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