ISO 13485 Audit Checklist

An ISO 13485 audit checklist is utilized by quality managers to determine if the organization’s QMS is aligned with the ISO 13485:2016 standard. It helps evaluate an organization’s readiness for a third-party ISO 13485:2016 certification audit. With SafetyCulture (formerly iAuditor), quality managers can:

1. Identify processes that don’t adhere to the corresponding ISO 13485:2016 requirement/s.

2. Create notes for corrective actions related to specific gaps discovered.

3. Assign corrective actions with deadlines.

4. Attach or upload photos and other media to provide further context on audit findings.

5. Add a digital signature to verify the completeness and accuracy of the audit.

6. Generate digital reports instantly and share them via Weblink, PDF, Word, Excel, or CSV for recordkeeping and store it securely on the cloud.

7. Download this converted checklist to suit the needs of the business for ISO 13485 certification.