MCT QMS T 22

1. Control of records related to quality:

• Is a mandatory procedure
• Requires that these records be at least in paper form
• Provides evidence of conformity and effectiveness of the QMS
• Requests that records be made available to interested parties

2. The mandatory procedures of ISO 13485 version 2016 are:

• + than 20
• - than 20
• 7

3. The medical device file contains:

• Process mapping
• Product description
• Nomenclature
• Measurement and monitoring processes

4. The general requirements request that the QMS be:

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

5. The processes are:

• Named
• Identified
• Their interactions determined
• Monitored
• Their objectives established and analysed