MCT Quality approach T 22

1. In the PDCA cycle, the A stands for:

• Analyse data
• Act
• Bring support
• Adapt

2. The following examples are medical devices:

• Sunglasses
• Medical gloves
• Syringe
• Nurse apron
• Diagnostic help software

3. ISO stands for:

• International Standard Organization
• International Organization for Standardization
• International Superior Organization

4. The standard ISO 13485 defines for a medical devices quality management system:

• The requirements
• The fundamentals
• Guidelines for auditing management systems
• The automotive production requirements

5. The 7 principles of quality management include:

• The quality approach
• The process approach
• Improvement
• Customer relations
• The quality policy
• Risk-based thinking