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quality-manager-qmr

Automates ISO 13485 management review preparation and action tracking for audit-ready outputs.

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

SYSTEM DOCUMENTATION & REQUIREMENTS

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

What problem does it solve?

The QMR quality management tracker automates ISO 13485 management review preparation, input collection, and action tracking to ensure timely governance and compliance.

Core Features & Use Cases

  • Automated inputs aggregation from audits, CAPA status, regulatory changes, and customer feedback
  • Action tracking with owners, due dates, escalation, and aging analytics
  • Output generation for management reviews, including decisions and improvement plans, ready for external audit

Quick Start

Run the management_review_tracker.py script with a sample JSON file to generate a status report.

Frequently Asked Questions about quality-manager-qmr

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

FAQPage Schema
How do I ensure my QMS management review meets Clause 5.6 requirements?▼

Meeting QMS management review Clause 5.6 requirements requires standardized templates and traceable decision records. This Skill delivers audit-ready outputs that align with ISO 13485 governance and compliance standards.

How do I track CAPA and audit actions for ISO 13485 compliance?▼

Tracking CAPA and audit actions for ISO 13485 compliance requires assigning owners, due dates, and monitoring escalation. This Skill automates action tracking with aging analytics to ensure timely decision making.

Does this management review tracker work for medical device organizations?▼

Yes, this management review tracker is designed for healthtech and medical device organizations requiring structured inputs, action tracking, and performance reporting to meet ISO 13485 Clause 5.6 requirements.

What is the best way to generate audit-ready QMS management review reports?▼

Generating audit-ready QMS management review reports is done by running the management review tracker script with a JSON file. It outputs standardized templates, decisions, and improvement plans for external audits.

How do I ensure my QMS management review meets Clause 5.6 requirements?▼

Meeting QMS management review Clause 5.6 requirements requires standardized templates and traceable decision records. This Skill delivers audit-ready outputs that align with ISO 13485 governance and compliance standards.

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