MCT Beginning 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. 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

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

• Purpose
• Strategy
• Documents and records
• Owner

5. The general requirements request that the QMS be:

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