ISO 13485 requirements
• To identify those processes that are vital to the system
• To determine the appropriate sequences and interactions of such processes
• To determine appropriate criteria and methods, thereby making process effectiveness certain
• To determine the availability of required resources
• To track, gauge, and analyze the processes necessary to reach the intended results
• To ensure that any outsourced activities comply with the standard
• Draft the quality manual
• Identify specific tasks to address gaps highlighted in the gap analysis
• Create specific procedures that require changes
• Assign tasks their expected completion dates