Description:
This Audit Procedure sets how we plan, run, and follow up audits to confirm QMS effectiveness and compliance across internal, supplier, and economic operator activities.

• Establish a risk-based Audit Program covering relevant activities and objectives.

• Define audit logistics using an Audit Plan (mandatory for external audits).

• Prepare and tailor an Audit Checklist aligned to applicable audit criteria.

• Apply a consistent Scoring System for Major NC, Minor NC, and OFI findings.

• Ensure auditor competence and Independence using the Matrix of Independence (LOG-AUD-001).

• Issue an Audit Report with objective evidence and clear, traceable statements.

• Drive timely follow-up through CAPA initiation, monitoring, and closure justification.

Your needs:

• Internal audit procedure

• Internal audit procedure for ISO 13485, MDR compliance

• Reduce rework, improve audit consistency, and strengthen inspection readiness.

Use this procedure to manage audits from program planning through reporting and CAPA follow-up, including audits aligned to ISO 19011, ISO 13485, (EU) 2017/745, 21 CFR Part 820, and MDSAP where applicable.

It covers audit governance and decision rules. Audit criteria are the requirements we assess against; they matter because they define what “conformity” means. Nonconformity grading (major/minor) matters because it drives escalation and CAPA priority.

• Define audit scope, objectives, criteria, and schedule in the Audit Program.

• Maintain auditor competence and verify independence for internal audits.

• Conduct opening/closing meetings and document attendee roles.

• Record objective evidence and classify findings as major/minor NC or OFI.

• Issue the audit report and communicate findings to responsible owners.

• Initiate CAPA or document justification for no CAPA when applicable.

At Lexqara, we implement audit-ready QMS workflows, checklists, and training, and we support internal audits and inspection preparation. Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 19011 [https://www.iso.org/standard/70017.html]. Request a short gap assessment.

A controlled audit process strengthens continuous improvement, improves cross-functional accountability, and keeps evidence clear long after the audit is closed.