Select all areas which are part of Quality Management system of LOC
Corrective and Preventive actions
Customer Service
Management Review
Financial reporting
Company social events
Storage of devices
Which standards belong to Quality Management system standards
ISO 9001
ISO 13485
ISO 11979-6
ISO 21500
What mean CE marking on medical devices
Carefully elected
Product is certified per Medical Device directive
Certified by European Parliament
Certified by 9001
What have to create first before building Quality Management System
Corrective and Preventive plan
Risk Management
Management Review
Quality Manual and Quality Policy
Quality certification
Contract with authority
Who can be ISO 9001 certified
Only Medical Device companies
Only joint stock companies
Every company
Nobody
What does mean PDSA cycle
Plan-Do- Study-Act
Pary-Dance-Suprise-Action
Product-Development-Safety-Accountability
Performance-Duty-Strength-Alert
Which type of documents are in QMS documentation structure on lowest level
Quality procedures
Work instructions
Quality records
Quality manual
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