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Medical Device Industry Audits


Periodic audits are a critical part of an effective Quality System. Audits are designed to assess whether:

  • Standard operating procedures (SOPs) and Work Instructions (WIs) comply with applicable regulations, standards, and Guidance documents
  • SOPs and WIs are consistently followed
  • Records required by applicable regulations and standards as well as by SOPs and WIs exist and are acceptable
  • FDA 483 warning letter responses are effectively resolved

Compliance audits are most often performed on behalf of Management and frequently are structured as a third party audit— meaning someone outside the organization performs the audit.

Properly planned audits can identify gaps in your present quality system and opportunities for improvements. Examples of typical audits include:

  • QSR and Design Controls
  • Software Used in Manufacturing
  • Part 11—Electronic Records/Signatures
  • ISO 13485—Quality System
  • ISO 14971—Risk Management
  • IEC 62304—Software Development Lifecycle

I hold ASQ Certifications as a Quality Auditor and Software Quality Engineer. I begin each audit with a detailed Audit Plan that identifies what, when, where, and who. The Audit Plan is reviewed and approved prior to the audit. Members of the client's staff are encouraged to participate on the Audit Team.

  • An Opening Meeting is held on the first day of the audit to review the audit process and the audit scope with all of the stakeholders and management.
  • Daily summary meetings are held to review the day’s findings.
  • A Closing Meeting is held on the last day of the audit with stakeholders and management in order to ensure everyone has a clear understanding of the audit findings and observations.

Once the audit is completed, a detailed Audit Report is prepared identifying the regulatory source for each finding. If requested, a detailed "gap analysis" is provided.

The Audit Report is reviewed and discussed with the client to ensure that the report is accurate and that findings are relevant.



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