| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 06.03.2014 14:23:27 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.1 Planning of product realization |
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Overview- Organisation Chart
- Staff
- Roles
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- 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
- 7 Product realization
- 7.1 Planning of product realization
7.1 Planning of product realization
«Functional» 7.1 Plan and develop the processes needed for product realization.- «Functional» 7.1 a) Determine quality objectives and requirements for the product
- «Functional» 7.1 b) Consider product specific processes, documents and resources
- «Functional» 7.1 c) Consider verification, validation, monitoring, inspection, test activities and acceptance criteria
- «Functional» 7.1 d) Consider records needed for realization processes and resulting product meet requirements
- «Functional» 7.1 Conider risks related to product realization
- 7.2 Customer-related processes
- 7.3 Design and development
- 7.4 Purchasing
- 7.5 Production and service provision
- 7.6 Control of monitoring and measuring devices
- 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