MCT Quality approach T 22

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

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

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

• Analyse data
• Act
• Bring support
• Adapt

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

• 1947
• 1980
• 1987

4. 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

5. The following examples are medical devices:

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