Conduct ISO 13485 internal audits
qms-audit-expertskillsetup L2★17,464
alirezarezvani/claude-skills ↗What it does
Audit quality management system for compliance gaps
Best for
Manufacturing/regulated teams needing routine compliance audits without external auditor costs.
Inputs
- · [object Object]
- · [object Object]
- · [object Object]
Outputs
- · [object Object]
- · [object Object]
- · [object Object]
Requires
- · document scanner
- · compliance knowledge base
- · report template
Preconditions
QMS documents accessible, audit scope defined, standard version specified
Failure modes
Missing documents, scope too broad, standard mismatch
Trust signals
- · Maps findings to specific clauses
- · Risk scoring consistent with audit standard
- · Traceable remediation