MCT Beginning T 22

1. The general requirements request that the QMS be:

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

2. Resource management requires that:

• A written procedure for staff is documented
• Staff have appropriate skills
• Staff is trained as needed
• Staff is aware of its contribution to quality objectives

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

• + than 20
• - than 20
• 7