- Implement ISO 13485-Quality Management System standard for Medical Devices in your organization. (E.g. Documenting, training the staffs with Awareness and Internal Audit, practicing the system, etc.)
- Conduct at least one internal Audit program through trained QMS Internal Auditors.
- Compile the collected data and complete the analysis.
- Conduct a Management review with the help of analyzed data and effect the decision towards improving the Organization’s performance in line with company objectives & goals.
- Complete the audit successfully. (Stage 1 and Stage 2)
- Closure of Non-conformance, if any.
- Collect and maintain the ISO 13485 certification.
- Comply with the surveillance audit annually.
