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qms-audit-expert

Automate ISO 13485 audit planning, execution, and CAPA integration for medical device organizations.

3|1|Updated Dec 21, 2025
Search Tags:#audit#compliance#qms#capa#iso-13485#nonconformity
One-click install
npx skills add https://github.com/I-Onlabs/claude-code-skills --skill qms-audit-expert-i-onlabs
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/I-Onlabs/claude-code-skills/tree/main/qms-audit-expert
Command: npx skills add https://github.com/I-Onlabs/claude-code-skills --skill qms-audit-expert-i-onlabs

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

Medical device organizations require a robust, compliant framework to plan, execute, and close audits, ensuring ongoing ISO 13485 conformity.

Core Features & Use Cases

  • Internal ISO 13485 audit program design, risk-based scheduling, and execution tooling.
  • Audit reporting, nonconformity management, and CAPA integration for continuous improvement.
  • External audit preparation and coordination, including regulatory inspections and certification body engagements.

Quick Start

Initiate an end-to-end QMS audit setup by loading standard templates and prompts for your internal audit program.

Frequently Asked Questions about qms-audit-expert

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I plan an ISO 13485 internal audit using risk-based scheduling?▼

ISO 13485 internal audit programs use risk-based scheduling to prioritize critical processes. This skill automates audit program design by generating schedules, execution tooling, and evidence-gathering templates tailored to medical device organizations.

What is the best way to manage nonconformities and integrate CAPA after a QMS audit?▼

Managing nonconformities requires linking audit findings directly to corrective actions. This skill integrates CAPA workflows by standardizing nonconformity documentation and enabling corrective action verification for continuous QMS improvement.

Can I use this to prepare for external regulatory inspections and supplier audits?▼

External regulatory inspections and supplier audits are supported through preparation and coordination tooling. The skill handles external audit engagements, certification body coordination, and post-market surveillance to ensure ISO 13485 conformity.

Does this skill handle auditor competency management and audit performance metrics?▼

Auditor competency management and performance metrics are included in the audit program design. The skill satisfies ISO 13485 requirements for documentation, competency tracking, and standardized audit performance measurement.

How do I set up an end-to-end QMS audit program with standardized templates?▼

Setting up a QMS audit program involves loading standardized templates and prompts for internal audits. This skill initiates the setup by providing end-to-end tooling for planning, execution, reporting, and CAPA closure.

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