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ISO 13485 audit prep (quality system) v1.0.0

Use this resource to prepare an internal audit or ISO 13485 certification

New

  • 480 downloads
  • 238 likes
  • 178 saves

Free

Install with the CLI

In a terminal, from the folder you want:

npx --yes palatekit@latest install iso-13485-audit-prep

With no option, the skill goes to ~/.agents/skills/; add --agent claude-code (or codex, cursor…) to target an agent.

First time: connect the CLI with

npx --yes palatekit@latest login

The command puts the scope through six evidence-based questions: design history files (DHF), CAPAs with effectiveness checks, process revalidation, risk management, post-market surveillance and management review. It produces an audit plan or a mock audit.

Mostly picked by

Updated November 2, 2026

Card for the “ISO 13485 audit prep (quality system)” skill

Details

Works in
Install guides
Generates with
Your agent's model
Licence
MIT

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What you get

  • SKILL.md: six evidence questions on design, CAPAs and risk
  • SKILL.md: two tracks, audit programme optimisation and mock audit

Good fit for

  • You are preparing the clause 8.2.4 internal audit before certification
  • You are launching a medical device and must close its design file

Not for

    Tags

    • ISO 13485
    • quality system
    • CAPA
    • medical device

    About

    You say

    “/compliance-os:iso13485-audit-prep on the infusion set, before the June audit.”

    Card for the “ISO 13485 audit prep (quality system)” skill

    Skill published by alirezarezvani under the MIT license, delivered in its original version.

    Show more

    How to use it

    1. Install the skill in your agent's skills folder
    2. Ask your agent to prepare an internal audit or ISO 13485 certification
    3. Review and adjust the result

    Content preview

    Files

    • LICENSE1.1 KB
    • NOTICE-PALATEKIT.md0.5 KB
    • SKILL.md6.9 KB

    Origin and licence

    Listed unmodified

    Author
    alirezarezvani
    Source
    github.com/alirezarezvani/claude-skills/tree/5434623a788ec3105d238328cfe554e1e2242ff7/compliance-os/skills/iso13485-audit-prep
    Licence
    MIT

    Notice

    « iso13485-audit-prep » (alirezarezvani, MIT) livré dans sa version d'origine : fiche en français et en anglais par PalateKit.

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