ISO 13485 Certification Process

In ISO 13485 certification a company has to establish many processes. Few Processes are as follows:

1. Design controls
2. Software development and problem reporting
3. Purchasing processes and vendor selection criteria
4. Receiving inspection, in-process and final acceptance processes and criteria
5. Process validations
6. Rework processes and decisions
7. Failure investigation
8. CAPAs
9. Quality audits
10. Recall procedure
11. Nonconforming product dispositions