ISO 13485 processes:
In ISO 13485 certification a company has to establish many processes. Few Processes are as follows:-
• Design controls
• Software development and problem reporting
• Purchasing processes and vendor selection criteria
• Receiving inspection, in-process and final acceptance processes and criteria
• Process validations
• Rework processes and decisions
• Failure investigation
• CAPAs
• Quality audits
• Recall procedure
• Nonconforming product dispositions