MCT Beginning T 22

1. The general requirements request that the QMS be:

• Documented and implemented
• Established, documented, implemented and maintained
• Established, documented and implemented

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 design and development outputs:

• Meet input requirements relating to product design and development
• Include applicable regulatory requirements
• Contain product acceptance criteria or a reference to them
• Specify characteristics for its safe use

4. 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

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