cyberneticlibrary
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Build ISO 13485 quality systems

quality-manager-qms-iso13485skillsetup L3★17,464
alirezarezvani/claude-skills ↗
What it does

Build and maintain ISO 13485 QMS from gap analysis through certification

Best for

Medical device manufacturers building a foundation for ISO 13485 certification and regulatory submission

Inputs
  • · gap analysis results
  • · required procedures checklist
  • · audit schedule
  • · CAPA tracking
Outputs
  • · Quality Manual
  • · documented procedures
  • · audit reports
  • · certification readiness
Preconditions
  • · Medical device company structure
  • · QMS governance established
  • · process owners assigned
Failure modes
  • · Gap analysis incomplete
  • · procedures not trained before use
  • · audit findings not closed
Trust signals
  • · ISO 13485:2016 Clause references
  • · gap analysis template
  • · mandatory documented procedures list