| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 17.04.2014 15:29:36 |
| Modified: | 27.02.2018 10:28:41 |
| Advanced : | |
| Appears In: | 5.3, 5.4, Manage external audits, QM_Quality Management |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
Process landscape
Management- Quality and Regulatory
Quality and Regulatory- QA_Quality Assurance
- QM_Quality Management
- QM_Quality Management
«BusinessProcess» Develop business process- «BusinessProcess» Do business process training
- «BusinessProcess» Do quality audits
- «BusinessProcess» Document control of QMS
- «BusinessProcess» Document control of records
- «BusinessProcess» Evaluate business process performance
- «BusinessProcess» Manage business process complaints
- «BusinessProcess» Manage external audits
- Manage external audits
«Activity» Apply for QM certification- «Activity» Create external audit plan
- «Activity» Create external audit report
- «Activity» Execute initial / surveillance ISO audit
- «Activity» Execute product surveillance audit
- «Activity» Inform about substantial modifications of QMS and products
«EndEvent» External audit done
«StartEvent» Time for external audit
«Gateway» QM system already certified?
- «BusinessProcess» Problem resolution process
- «BusinessProcess» Publish QMS
- RA_Regulatory Affairs
- RM_Risk Management
- «BusinessProcess» Plan resources and budget Q&R
- «BusinessProcess» Report Q&R
- Clinical Marketing
- Research and Development
- Operations
- Customer Support
- Sales
- Finance
- Information Technology
- Human Resources
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
- Sandbox