MCT Beginning T 22

1. The standard ISO 13485 defines for a medical devices quality management system:

• The requirements
• The fundamentals
• Guidelines for auditing management systems
• The automotive production requirements

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

• Purpose
• Strategy
• Documents and records
• Owner

4. Top management commitment is, among other things:

• 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 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