FAQ
Frequently asked questions
Is this tool suitable for a formal ISO 13485 certification audit?
This tool is designed as a preparatory self-assessment, not a substitute for a formal third-party audit conducted by an accredited certification body. It helps organizations identify gaps and areas for improvement prior to a formal assessment, making the certification process more efficient and cost-effective.
Is my data stored or shared?
All audit responses, document references, and notes are processed entirely within your browser session. No audit data is stored on our servers. The only information we retain is your email address if you choose to request a report preview, which is handled in accordance with our privacy policy.
How does the AI follow-up question feature work?
After each response, our AI analyses your answer, document references, and notes in real time. When it detects a gap, partial compliance, inconsistency with previous answers, or ambiguous language in your notes, it automatically generates up to three targeted follow-up questions to help you document the issue more precisely. This information is then included in your audit report.
Can I exclude clauses that are not applicable to my organization?
Yes. The scope configuration step at the beginning of the audit allows you to exclude entire clause groups — such as design and development (clause 7.3), sterilization requirements, or implantable device traceability — based on your organization's activities. Each exclusion is documented with a justification and appears clearly in the final report as "Not Applicable".
What does the Word report include?
The report includes a cover page with your organization details, an executive summary with a statistical breakdown of findings, detailed findings for each clause with your responses and document references, and a consolidated gap summary table. It is formatted professionally and ready to share with your management team or regulatory consultants.
How long does the audit take to complete?
Depending on the scope of your QMS and how many clauses apply to your organization, a complete audit typically takes between 45 and 90 minutes. You can work through it in a single session or return to it at any time — though please note that responses are not saved between browser sessions.