AI ISO 13485 Evidence Gap Review
Paste excerpts from your Quality Manual, SOP index, internal audits, CAPA records, management reviews, or other QMS evidence. The agent inventories what you supplied, reviews implementation evidence, and returns a practical, prioritized gap report.
Paste your QMS evidence
Paste a Quality Manual excerpt, SOP index, internal-audit report, CAPA summary, management-review notes, supplier controls, or an evidence list. The review focuses on implementation evidence, not whether a procedure title exists.
What to paste for a useful review
Include document names and excerpts that show how processes operate: recent sampled records, audit findings, CAPA effectiveness, management decisions, supplier monitoring, complaint or vigilance decisions, and other objective evidence. A document index alone can identify missing coverage, but it cannot demonstrate implementation.
Separate sources with simple headings and state the products, sites, outsourced processes, and markets in scope. The report distinguishes an explicit deficiency from an area that simply could not be assessed from the material provided.
- Is this an official ISO 13485 checklist?
- No. It is an independent readiness tool with paraphrased process prompts. It does not reproduce the standard and does not replace a licensed copy of ISO 13485 or certification-body criteria.
- Can this checklist certify an ISO 13485 QMS?
- No. Certification can only be issued through the applicable accredited certification process. This tool helps organize an internal gap assessment.
- Should every question be marked ready before an audit?
- Applicable areas should have implemented, consistent, and objective evidence. A documented procedure alone may not demonstrate effective implementation.
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