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Answer

 

  • 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.
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