Management Department Policy & Direction
Business Planning QA/RA-Department Resource Management
Measurment, Analysis &
QM – Quality Policy & Quality Manual
Improvment
SOP 01- Management Responsibility and Review SOP 10 - CAPA SOP 08 - Document Control/Quality Records
SOP 20- Regulatory Change Management SOP 14 - Data Control SOP 02 - Personnel and Training
SOP 13 - Internal Quality Audit SOP 04 - Supplier Evaluation
SOP 19 - Internal and external communication SOP 05 - Purchaising
Policy & Direction Resources
Results/Data Improvements
Product Realization
Process
customer needs
Development
SOP 15 - Software & Design Development SOP XX - Product Manufactoring SOP XX - Storage & Distribution
SOP 03 - Risk Management SOP 06 - Outsourced Processes
SOP 18 - Continual Improvment SOP 17 - Receiving and Incoming Inspection
SOP 21- Process Validation
SOP 09 – Control of Non-Conforming Products
customer satisfaction
customer approach & requirments
Sales & Marketing Customer-Related Processes
SOP 16 - Product Identification and Traceability SOP XX - Customer Orders
SOP XX - … SOP 11 - Complaint Handling
SOP 12 - Customer Feedback
SOP XX - Clinical Evaluation