Guide · Agent skill
How to use the ISO 13485 Audit Prep agent skill
Updated · written with AI from the project's own documentation and checked against our catalogue data
The iso13485-audit-prep skill makes an AI agent act like a strict ISO 13485 auditor for medical-device quality management. 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. This guide explains what the skill does, how to install it, how to trigger it, and what it needs to work well.
ISO 13485 Audit Prepalirezarezvani/claude-skills · MIT Download the skill Quick start
- 1Download the ZIP. Download the skill ZIP from this page. It contains SKILL.md from the compliance-os plugin.
- 2Unzip into a skills folder. Unzip it into ~/.claude/skills/ for all projects, or into a project's .claude/skills/ folder for one project.
- 3Or upload in the Claude apps. In the Claude apps, go to Settings → Capabilities → Skills and upload the skill.
- 4Install the dependencies. Make sure the compliance-os plugin, the ra-qm-team vendor files and sibling skills such as cs-fda-qsr-auditor are available.
- 5Gather your evidence. Collect DHFs, the last five CAPAs, process validation records, risk files, complaint logs and management review minutes.
- 6Run the command. Invoke /compliance-os:iso13485-audit-prep with your scope, or describe the audit in plain language.
- 7Act on the verdict. Read the READY, CLOSE-GAPS-FIRST or NOT-READY verdict and work through the three prioritized actions with named owners.
What the skill makes the agent do
Agent skills are instruction packs that an AI agent such as Claude Code loads when a request matches them. This one is built for medical-device quality work. Before an internal audit, an MDR or FDA QSR review, or a product launch, the agent works through six questions in order, asking for the evidence behind each one.
The six areas are: design history file (DHF) verification and validation evidence, the last five CAPAs with effectiveness checks, process validation (IQ/OQ/PQ) revalidation, the risk management file for the highest-risk product, post-market surveillance over the last six months, and management review covering the Clause 5.6 inputs.
The output is a readiness report with a verdict of READY, CLOSE-GAPS-FIRST or NOT-READY, plus three prioritized actions. It is a structured checklist and report template, not a certified audit.
Install the skill from the ZIP download
Download the ZIP for this skill from this page. The skill is distributed as a single file, SKILL.md, inside the compliance-os plugin folder of the alirezarezvani/claude-skills repository.
Unzip it into one of two locations. Use ~/.claude/skills/ to make it available in all your projects, or use a project's .claude/skills/ folder to limit it to one project.
If you use the Claude apps instead of Claude Code, you can upload the skill under Settings → Capabilities → Skills.
- Personal install: unzip into ~/.claude/skills/
- Project install: unzip into the project's .claude/skills/ folder
- Claude apps: Settings → Capabilities → Skills, then upload
Trigger the skill with a natural request
You can invoke the skill with its command, /compliance-os:iso13485-audit-prep followed by a scope, such as a product line or the QMS area you are auditing. You can also describe the situation in plain language, such as asking the agent to prepare you for an internal ISO 13485 audit. Name the situation clearly so the agent loads the right checks.
Give the agent the files it needs in the same request. The skill relies on the evidence you provide, so point it to your DHF index, CAPA log, complaint log, or management review minutes.
- Before our annual Clause 8.2.4 internal audit, run the ISO 13485 prep on the infusion pump line.
- Run an ISO 13485 readiness check on the DHF closure for the new device before launch.
- Review our CAPA effectiveness evidence after the last complaint trend.
/compliance-os:iso13485-audit-prep <scope>Know what it needs before you run it
The skill depends on other parts of the compliance-os plugin. For the workflow steps to work, you need Claude Code or a SKILL.md-compatible agent with the compliance-os plugin installed, the referenced vendor files under ra-qm-team (qms-audit-expert, capa-officer, risk-management-specialist), and sibling skills such as cs-fda-qsr-auditor. Without them, the report can be incomplete.
The workflow also calls Python scripts, audit_schedule_optimizer.py and audit_simulator.py. These scripts are not included in the SKILL.md file reviewed, so you must obtain them separately.
- Claude Code or a SKILL.md-compatible agent with the compliance-os plugin
- Referenced ra-qm-team vendor files and sibling skills such as cs-fda-qsr-auditor
- Python to run audit_schedule_optimizer.py and audit_simulator.py (not included in SKILL.md)
Safety notes on scripts and network use
This skill runs scripts. The workflow calls Python audit scripts on files you supply, so review those scripts before running them and only run ones you trust. The skill does not use the network, according to the review of its SKILL.md.
The skill does not read your actual DHFs or CAPA records automatically. It works from the files you provide, so keep confidential quality records to the minimum needed for the review.
- Runs scripts: yes. Review the Python audit scripts before use.
- Uses network: no.
- Keep sensitive QMS records limited to what the review needs.
Tips for a useful readiness report
The report is only as good as the evidence. Prepare the DHFs, CAPA records with effectiveness verification, validation revalidation dates, risk files and management review minutes before you run the skill, so the verdict reflects your real state.
Use the skill to find gaps early, then make the decisions yourself. Legal and regulatory sign-off needs accountable people, so the verdict is an input to your review, not a final answer.
- Gather evidence first; the verdict reflects what you supply.
- Start with the most-cited areas: DHFs and CAPA effectiveness.
- Treat the three top actions as a starting list, and assign owners yourself.
What people use it for
- Preparing for an annual Clause 8.2.4 internal audit by checking DHF completeness and CAPA effectiveness evidence.
- Checking design history files before a new-device commercial launch.
- Reviewing CAPA effectiveness and post-market surveillance after a complaint trend or recall.
- Aligning a quality system with MDR or FDA QSR requirements before a regulatory submission review.
Frequently asked questions
Is the ISO 13485 Audit Prep skill free and what is its licence?
The skill is published under the MIT licence in the alirezarezvani/claude-skills repository. The source does not state any price, so check the repository for current terms.
How do I install the iso13485-audit-prep skill?
Download the ZIP from this page and unzip it into ~/.claude/skills/ for all projects or into a project's .claude/skills/ folder. In the Claude apps, you can upload it under Settings → Capabilities → Skills.
What do I need to run the ISO 13485 audit prep skill?
You need Claude Code or a SKILL.md-compatible agent with the compliance-os plugin, the ra-qm-team vendor files (qms-audit-expert, capa-officer, risk-management-specialist), sibling skills such as cs-fda-qsr-auditor, and Python for the audit scripts.
Does the skill read my DHFs and CAPA records automatically?
No. It relies on the files you provide. Without the evidence, the readiness report will be incomplete.
Can this skill replace a notified body or ISO 13485 auditor?
No. It is a self-assessment checklist and report template. Notified bodies, qualified auditors and regulatory counsel are still needed for certification and legal sign-off.
Can I use it for a non-medical-device company?
No. The framework and questions are specific to ISO 13485, MDR and FDA QSR, so the checks would not apply to other organizations.
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Our verdict
Use this skill if you are a quality or regulatory team preparing for an internal ISO 13485 audit, notified body review, or a device launch, and you can supply the underlying records. Skip it if you are outside medical devices, need a certified audit, or expect it to read your quality records on its own; use a qualified auditor or regulatory counsel instead.
Download the skill