| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 06.03.2014 15:56:38 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 7.2.2 Review of requirements related to the product |
|
|
|
|
|
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
- 7 Product realization
- 7.1 Planning of product realization
- 7.2 Customer-related processes
- 7.2 Customer-related processes
- 7.2.1 Determination of requirements related to the product
- 7.2.2 Review of requirements related to the product
7.2.2 Review of requirements related to the product
«Functional» 7.2.2 a) Ensure that product requirements are defined and documented- «Functional» 7.2.2 b) Ensure that contract or order requirements differing from thos previously expressed are resolved
- «Functional» 7.2.2 c) Ensure that the organization has the ability to meet the defined requirements
- «Functional» 7.2.2 Records or the review results shall be maintained
- «Functional» 7.2.2 Customer requirements shall be confirmed by the organization before acceptance
- «Functional» 7.2.2 Product changes shall be communicated and documented
- 7.2.3 Customer communication
- 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