MCT Quality approach T 22

1. ISO stands for:

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

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

• Analyse data
• Act
• Bring support
• Adapt

3. 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

4. A requirement of ISO 13485 may be excluded when:

• This is justified in the quality manual
• Product conformity is not affected
• Never

5. A supplier is:

• An organization or a person that receives a product
• The result of a process
• An organization or a person that provides a product