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QMS
Last update: 2019-05-02
Risk Management
Production & Process Controls
Risk Analysis for Non-Product SW
Corrective and Preventive Action
Document Controls
Facility and Equipment Controls (pest)
Design Control (Phases)
Test Equipment Calibration
Process Validation
Good Documentation Practices
Control of Nonconforming Product
Management Responsibility and Reviews
Internal Audits
Quality Policy
Company Organisation Chart
Product Inspection and Test
Change Control for Technical Documents
Electrostatic Discharge
Good Lab Practice:
New Employee Training
Risk Plan
Risk Assessment
Risk Report
Complaint Handling and MDR
Non-Product SW
Customer Excellence /User Information
Label Controls
Validation Master plan: VMP
Process Deviation
Defect Reporting
Service Support Installation
Material Creation Request
First Article Inspection
Data Analysis
Post Market Surveillance
Customer Change Notification
Design Control (DDP)
Consumables Design V&V
Clinical Trails
Sample Size Selection
Purchasing Material Controls
Supplier Management:
Return of Instruments
Import/Export
Work on Tenders
Development of Contracts
Receiving and Warehouse
Facilities Maintenance
Work Area Final Assembly (not Leipzig)
Configuration Management
Order Review & Processing
Order Processing
Order Fulfillment (shipping)
Electronic Request
Outsourcing
Inventory Control
Contract Management
Creation & Management of D1/D2 Report
Clearing Inventory
Material Return to Vendor
Production CARE
Document owner/archive Matrix
Structures and approvals of products in ERP
Quality Management Handbook
User Information - Functions and Responsibilities
Data drive disposal
Data backup
SW release
SW Design V&V
SW Master Build
Health Hazard Evaluation
Post Release Product LifeCycle Management
Creation of Validation Legal Documents:
Conducting Supplier Audits
Field Action
Definition, creation and maintenance of DMR
Design verification master plan
Device Master Record index
Excursion/Event Process
Biological Safety and decontamination
Advertising and Promotional Material
Creation DMR
Supplier Corrective Action Report
Cleaning process
Mandatory process Validation
Special Incoming Inspection
