| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 07.03.2014 09:59:57 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.5.1.1 General requirements |
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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
- 7 Product realization
- 7.1 Planning of product realization
- 7.2 Customer-related processes
- 7.3 Design and development
- 7.4 Purchasing
- 7.5 Production and service provision
- 7.5 Production and service provision
- 7.5.1 Control of production and service provisions
- 7.5.1 Control of production and service provisions
- 7.5.1.1 General requirements
7.5.1.1 General requirements
«Functional» 7.5.1.1 a) Availability of information that describes the characteristics of the product- «Functional» 7.5.1.1 b) Controlled conditions shall include procedures, requirements, work instructions and reference materials and measurement procedures
- «Functional» 7.5.1.1 c) Use of suitable equipment
- «Functional» 7.5.1.1 d) Availability and use of monitoring and measuring devices
- «Functional» 7.5.1.1 e) Implementation of monitoring and measurement
- «Functional» 7.5.1.1 f) Implementation of release, delivery and post-delivery activities
- «Functional» 7.5.1.1 g) Implementation of defined operations for labelling and packaging
- «Functional» 7.5.1.1 Records for each batch of medical devices
- 7.5.1.2 Control of production and service provisions - Specific requirements
- 7.5.1.3 Particular requirements for sterile medical devices
- 7.5.2 Validation of processes for production and service provision
- 7.5.3 Identification and traceability
- 7.5.4 Customer property
- 7.5.5 Preservation of product
- 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