MCT Beginning T 22

1. 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

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 mandatory procedures of ISO 13485 version 2016 are:

• + than 20
• - than 20
• 7

4. Examples of top management commitments:

• Communicated and understood at all levels by all
• To establish and promote policy
• To ensure availability of necessary means
• Formalized in a written declaration
• To conduct management reviews at planned intervals

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

• Purpose
• Strategy
• Documents and records
• Owner