Quality - SOP - Corrective and Preventive Actions

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The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (8.5), 21 CFR (820.100), and EU MDR/IVDR.

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Purpose of Document

The purpose of this procedure is to document the controls that are exercised over the corrective action and preventive action programs within Company.
Corrective and preventive actions are necessary steps in the quality improvement cycle and are required for compliance with ISO 13485 (8.5), 21 CFR (820.100) and EU MDR/IVDR.

Scope of Document/s

Corrective and preventive actions are necessary steps in the quality improvement cycle. When non-conformities occur or potential issues are identified, rapid intervention is required to gauge the extent of the problem, determine, and eliminate the root cause(s), prevent recurrence or occurrence, and to confirm the effectiveness of implemented actions. The CA/PA system is also vital to promote the optimisation of processes and the continuous improvement cycle.

This procedure will outline the steps taken to:

  • Define the triggers for a new CA/PA
  • Outline responsibilities in the CA/PA process
  • Explain the workflow to raise a new CA/PA
  • Explain the workflow to resolve a CA/PA
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