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qms-audit-expert

Plan and execute ISO 13485 internal audits for medical device QMS compliance.

Updated Dec 23, 2024
Search Tags:#audit#compliance#qms#capa#iso-13485#nonconformity
One-click install
npx skills add https://github.com/salamientark/dotfiles --skill qms-audit-expert-salamientark
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: qms-audit-expert
Source: https://github.com/salamientark/dotfiles/tree/main/claude/skills/ra-qm-team/qms-audit-expert
Command: npx skills add https://github.com/salamientark/dotfiles --skill qms-audit-expert-salamientark

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

ISO 13485 internal audits are essential for regulatory compliance but can be fragmented and inconsistent. This skill provides a cohesive framework to plan, execute, classify nonconformities, and verify CAPA effectiveness across internal and external audits.

Core Features & Use Cases

  • Comprehensive audit planning and execution workflow aligned to ISO 13485:2016.
  • Nonconformity classification and CAPA verification templates for rapid remediation.
  • External audit readiness guidance and mock audit protocols with reference materials.

Quick Start

Generate an ISO 13485 internal audit plan for a mid-sized medical device company.

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 and execute an internal audit for ISO 13485 compliance?▼

To plan an internal audit for ISO 13485 compliance, define scope and generate checklists using a structured workflow. Execution involves systematic evidence collection and documenting findings against regulatory clauses.

What is the best way to classify nonconformities found during a QMS audit?▼

Classifying nonconformities during a QMS audit involves categorizing findings by severity and regulatory impact. Built-in classification templates help standardize this process for rapid remediation tracking.

How do I verify CAPA effectiveness after an ISO 13485 internal audit?▼

Verifying CAPA effectiveness requires reviewing corrective action implementation and confirming resolved issues. Structured verification templates guide evidence evaluation to ensure sustained compliance post-audit.

Can I use this framework to prepare for external ISO 13485 audits?▼

Yes, you can use this framework for external audit preparation. It provides mock audit protocols and readiness guidance to evaluate QMS compliance before external regulatory assessments.

Does this ISO 13485 audit methodology include evidence collection templates?▼

Yes, this ISO 13485 audit methodology includes built-in evidence collection templates. These templates provide a structured format to document findings and support comprehensive audit program management.

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