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

• Purpose
• Strategy
• Documents and records
• Owner

3. The general requirements request that the QMS be:

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

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. 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