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Quality Manager Qms Iso13485

Listed
alirezarezvani·vlatest·other·MIT

This AI manages ISO 13485-compliant quality management systems, ensuring regulatory adherence and improved product safety/reliability for medical devices.

Repository

Install on your platform

Showing Claude Code. One command installs this skill into any of the agents below.

  1. 1

    Run this in your project

    terminal
    $ npx skills add alirezarezvani/claude-skills --skill quality-manager-qms-iso13485 -a claude-code

  2. Uses the open-source skills CLI and needs Node.js. Add -g to install it for your user instead of this project.

What we know about this skill

Publisher

alirezarezvani

Taken from the source listing. We haven't verified who controls this account.

Install target

Live repository

Not pinned. Installing fetches whatever the repository holds at the time you run the command.

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Automated safety checks

scanned

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Not scanned. none of the 253 skills in the repository match this slug — it was most likely renamed or removed upstream after the registry indexed it Source recorded as alirezarezvani/claude-skills.
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About this skill

What it does

This skill allows AI agents to manage Quality Management Systems (QMS) according to ISO 13485 standards. It can assist with document control, CAPA management (Corrective and Preventive Actions), and internal audits required for medical device quality systems. The agent understands the principles of ISO 13485 and can help ensure compliance.

When to use it

  • Document Review: Need a quick check of a QMS document against ISO 13485 requirements? Use this skill to identify potential gaps or areas for improvement.
  • CAPA Investigation Support: Facing a quality issue requiring investigation and corrective action? The agent can help structure the CAPA process and ensure all necessary steps are followed.
  • Internal Audit Preparation: Preparing for an internal audit of your QMS? This skill can assist in creating checklists and identifying potential non-conformances.
  • Risk Assessment: Conducting a risk assessment related to product quality or process controls, the agent can help identify hazards and evaluate risks according to ISO 13485 guidelines.

Key capabilities

  • ISO 13485 standard knowledge
  • Document control assistance
  • CAPA management support
  • Internal audit preparation

Example prompts

  • "Review this document [paste document text] and identify any areas that do not align with ISO 13485."
  • "Help me structure a CAPA plan for this quality event: [describe the event]."
  • “Create an internal audit checklist for our manufacturing process, referencing relevant clauses from ISO 13485.”

Tips & gotchas

The agent's effectiveness depends on providing clear and detailed information about your QMS processes. While it understands ISO 13485 principles, it cannot replace the expertise of a qualified quality professional.