Published by Adaptive Life Science
Specialists in Medical Device, IVD, and Biotech Recruitment
Why Internal Audits Matter in ISO 13485:2016
Internal audits are a cornerstone of any compliant Quality Management System (QMS) under ISO 13485:2016. For Quality Engineers, Regulatory Affairs professionals, and QMS leaders, these audits are not just about ticking boxes—they’re about ensuring product safety, regulatory readiness, and continuous improvement.
ISO 13485:2016 requires organizations to conduct internal audits at planned intervals to verify:
- Conformance to the standard and internal procedures.
- Effective implementation and maintenance of the QMS.
Your ISO 13485:2016 Internal Audit Checklist
Use this checklist to guide your next internal audit and ensure nothing is overlooked:
1. Audit Planning
- ▢ Define audit scope, objectives, and criteria.
- ▢ Develop an audit schedule covering all QMS processes.
- ▢ Assign trained, independent auditors.
2. Document Review
- ▢ Review the Quality Manual and relevant SOPs.
- ▢ Verify document control and change management procedures.
- ▢ Ensure risk management files are current and aligned with ISO 14971.
3. Process Audits
- ▢ Evaluate design and development controls.
- ▢ Assess production and process validation.
- ▢ Review supplier evaluation and purchasing controls.
- ▢ Check complaint handling and post-market surveillance.
4. Records and Evidence
- ▢ Verify training records and staff competency.
- ▢ Review CAPA records and effectiveness checks.
- ▢ Confirm traceability and batch records are complete and accessible.
5. Audit Reporting
- ▢ Document findings clearly (conformities, nonconformities, observations).
- ▢ Assign corrective actions with deadlines and responsible owners.
- ▢ Communicate results to top management.
6. Follow-Up
- ▢ Verify implementation of corrective actions.
- ▢ Assess effectiveness of changes.
- ▢ Update risk assessments and procedures if necessary.
Bonus Tip: Align with MDR and FDA QMSR
With the EU MDR and the FDA’s QMSR increasingly harmonized with ISO 13485:2016, internal audits should also consider these frameworks. This ensures global compliance and reduces the risk of regulatory surprises.
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