MCT Beginning T 22

1. The documented procedure for preventive action includes:

• The determination of potential nonconformities and their causes
• The verification of adverse effects of preventive actions
• Recording investigation results
• The systematic implementation of preventive actions

2. 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

3. The internal audit:

• Verifies the skills of the staff
• Allows the conformity of the QMS to be evaluated
• Allows the effectiveness of the QMS to be evaluated
• Contributes to the improvement of the efficiency of the QMS

4. A process is determined, among other things, by its:

• Purpose
• Strategy
• Documents and records
• Owner

5. Resource management requires that:

• A written procedure for staff is documented
• Staff have appropriate skills
• Staff is trained as needed
• Staff is aware of its contribution to quality objectives