Prepare ISO 13485 audit
iso13485-audit-prepskillsetup L2★17,464
alirezarezvani/claude-skills ↗What it does
Audit iso13485 audit prep compliance
Best for
When you need structured iso13485 readiness before certification audits.
Inputs
- · [object Object]
Outputs
- · [object Object]
Requires
- · python_scripts
- · audit_playbook_reference
Preconditions
- · Audit scope defined
- · Evidence inventory collected
- · Auditor independence verified
Failure modes
- · Incomplete input scope definition
- · Missing required metadata or configuration
- · Timeout on external API calls
- · Authorization failures
Trust signals
- · Published by RA/QM compliance team
- · References ISO standard annexes
- · Cross-references related audit skills