Description:
This matrix documents auditor independence by listing each Auditor and the Restricted audit areas they must not audit (e.g., specific QMS processes, QSPs, or named DHF/DMR elements), so we can demonstrate impartial audit planning and avoid conflicts of interest.

• Record each Auditor (Name, Surname) to uniquely identify who is subject to restrictions

• List Restricted audit areas with sufficient specificity (processes, procedures, DHF/DMR topics) to prevent self-auditing

• Ensure restricted areas reflect prior involvement (authoring, approving, executing, or owning the activity being audited)

• Maintain controlled Revision and Change History to track updates to independence assignments

• Capture formal Approval (Name, Position, Date, Signature) for governance and accountability

Your needs:

• Matrix of independence

• Matrix of independence for ISO 13485 compliance

• Reduce audit risk and strengthen impartiality evidence across internal/external audit planning

Use this matrix when scheduling audits and assigning auditors, especially where auditors also support QMS activities, to ensure impartiality and defensible auditor selection.

Key requirements covered include defining Restricted audit areas (documented boundaries that prevent auditing one’s own work) and Change History (controlled traceability of updates to independence constraints).

• Identify each Auditor and maintain a current roster

• Define Restricted audit areas at the process/QSP/DHF/DMR level

• Prevent self-auditing and perceived bias through documented exclusions

• Keep revision control using Revision and Change History

• Obtain management Approval with signature and date

• Maintain confidentiality controls for audit governance records

At Lexqara, we help implement impartial audit programs, integrate independence controls into QMS routines, and support audit readiness through audits support and training. Use our Resource Center [https://lexqara.com/resource-center] and Audits & Training [https://lexqara.com/services/audits-training], and align governance expectations with the European Commission medical devices sector overview [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template and request a short gap assessment.