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 mandatory procedures of ISO 13485 version 2016 are:

• + than 20
• - than 20
• 7

3. The review of product requirements includes:

• A documented procedure
• The assurance of being able to meet the explicit and implicit requirements
• Identification of business processes

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

• Purpose
• Strategy
• Documents and records
• Owner