ISO 13485 and FDA 21 CFR Part 820 Compliance Project Template

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Stay ahead in the medical devices industry by ensuring full compliance with ISO 13485 and FDA 21 CFR Part 820. This template helps you track and prioritize tasks using the Quadrants method, ensuring no important compliance steps are overlooked.

From reviewing current compliance status to preparing for internal and external audits, this template guides you through every crucial step, helping you maintain regulatory standards efficiently.

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ISO 13485 and FDA 21 CFR Part 820 Compliance Project for Priority Matrix

ISO 13485 and FDA 21 CFR Part 820 Compliance Project in Priority Matrix

Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 using a structured task management approach.

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Proposed Tasks

High Impact, Urgent

  • Task 1: Review Current Compliance Status - due in 1 week
    ☐ Identify areas of non-compliance ☐ Document findings ☐ Formulate action plan
  • Task 2: Implement Compliance Measures - due in 2 weeks
    ☐ Train staff on compliance measures ☐ Update procedures and documentation
  • Task 9: Compliance Training - due in 6 months
    ☐ Conduct training on new compliance measures ☐ Review staff understanding of compliance measures

High Impact, Not Urgent

  • Task 4: Compliance Monitoring - ongoing
    ☐ Regularly review compliance status ☐ Update procedures and documentation as needed
  • Task 3: Internal Audit - due in 1 month
    ☐ Prepare for audit ☐ Conduct audit ☐ Review audit findings ☐ Implement corrective actions
  • Task 10: Compliance Training Evaluation - due in 6.5 months
    ☐ Evaluate effectiveness of training ☐ Make necessary adjustments to training

Low Impact, Urgent

  • Task 5: External Audit Preparation - due in 3 months
    ☐ Prepare necessary documentation ☐ Train staff for external audit
  • Task 6: External Audit - due in 4 months
    ☐ Facilitate external audit ☐ Review audit findings ☐ Implement corrective actions

Low Impact, Not Urgent

  • Task 7: Compliance Report Preparation - due in 5 months
    ☐ Collect and analyze compliance data ☐ Prepare compliance report
  • Task 8: Compliance Report Review - due in 5.5 months
    ☐ Review compliance report ☐ Implement changes based on report