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ISO 13485 Audit Prep

Pressure-tests medical-device QMS work with six audit questions before an internal or regulatory audit

Source Download skill
Repository
alirezarezvani/claude-skills
Stars
29,149
Licence
MIT
Files
1 file

What it does

This skill makes the agent act like a strict ISO 13485 auditor for medical-device quality management. Before an internal audit, MDR or FDA QSR review, or product launch, it asks six traceability-focused questions covering design controls, CAPAs, process validation, risk management, post-market surveillance and management review, then produces a readiness report with a READY, CLOSE-GAPS-FIRST or NOT-READY verdict and three prioritized actions. It is a structured checklist and report template, not a certified audit.

Great for

  • Quality and regulatory teams preparing for an internal ISO 13485 audit or notified body review
  • Medical-device companies checking design history files before a product launch
  • Teams reviewing CAPA effectiveness and post-market surveillance after a complaint trend or recall

Skip it if

  • Replacing a qualified auditor, notified body or regulatory counsel; the output is a self-assessment that depends on the evidence supplied (reason: legal and regulatory sign-off requires accountable humans)
  • Non-medical-device organizations, since the framework and questions are specific to ISO 13485, MDR and FDA QSR (reason: the checks would not apply)
  • Teams expecting it to read their actual DHFs or CAPA records automatically; it relies on files the user provides and references playbooks and sibling skills that must be installed separately (reason: missing dependencies produce incomplete reports)

Try asking

  • “Run an ISO 13485 audit prep for our insulin pump scope before the annual Clause 8.2.4 internal audit”
  • “Check whether our last five CAPAs have effectiveness verification evidence”
  • “Review our risk management file for the highest-risk product ahead of MDR alignment review”
  • “Prepare a management review readiness check covering all Clause 5.6.2 inputs”
Step-by-step guide: how to use ISO 13485 Audit PrepInstall, first run, examples, tips and FAQs

Install in 3 steps

  1. 1

    Download the skill

    The ZIP contains the 1 original files, the MIT licence and an attribution note.

    iso13485-audit-prep.zip
  2. 2

    Add it to your agent

    Claude Code (all projects)

    mkdir -p ~/.claude/skills && unzip iso13485-audit-prep.zip -d ~/.claude/skills/

    Claude Code / Agent SDK (this project only)

    mkdir -p .claude/skills && unzip iso13485-audit-prep.zip -d .claude/skills/

    Claude apps (web/desktop): Settings → Capabilities → Skills → Upload skill, and choose the ZIP.

  3. 3

    Ask for the task

    No special command needed — the agent reads the skill's description and loads it when your request matches. Try one of the prompts above.

Get better results

  • Supply real evidence files (DHF index, CAPA log, complaint log) so the pass/fail judgements reflect your actual records rather than assumptions
  • Treat the verdict as an internal readiness signal and have a qualified QA/RA professional validate findings before acting on them
  • Confirm the referenced scripts and playbooks exist in your installation and review the scripts before running them, since the workflow executes Python

What's inside

  • SKILL.md

Redistributed unmodified from alirezarezvani/claude-skills under the MIT licence. The assessment was drafted with AI from the skill's files on 2026-10-29. Skills can instruct your agent to run code — read SKILL.md and any scripts before installing.