MCT Quality approach T 22

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

• 1947
• 1980
• 1987

2. The following examples are medical devices:

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

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. ISO stands for:

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