MCT Quality approach T 22

1. 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

2. 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

3. The first edition of the ISO 9000 family of standards appeared in:

• 1947
• 1980
• 1987

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

• Analyse data
• Act
• Bring support
• Adapt

5. ISO stands for:

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