MCT Beginning T 22

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

• Purpose
• Strategy
• Documents and records
• Owner

2. 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

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. The mandatory procedures of ISO 13485 version 2016 are:

• + than 20
• - than 20
• 7

5. The general requirements request that the QMS be:

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