Senior Quality Manager Responsible Person (QMR)
This skill provides a structured framework for a Senior Quality Manager Responsible Person (QMR) in HealthTech and MedTech companies, covering quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. It includes workflows, templates, and decision frameworks to help manage quality responsibilities effectively.
✨ What it does
- Provides a QMR accountability matrix and authority boundaries.
- Includes a detailed management review workflow with input templates and output requirements.
- Offers a quality KPI framework with core KPIs, targets, and review frequencies.
- Guides annual quality objectives setting with structure and quarterly review.
- Provides a quality culture assessment workflow with dimensions and improvement actions.
- Includes a multi-jurisdictional regulatory compliance matrix and monitoring workflow.
🎯 When to use it
- When leading or preparing for management reviews as per ISO 13485 Clause 5.6.
- When setting or updating quality policy, objectives, and KPIs.
- When monitoring quality performance, cost of quality, or quality culture.
- When exercising QMR governance and regulatory oversight responsibilities.
- When needing to report QMS effectiveness to top management.
🚀 How to use
Trigger the skill by asking for help with management reviews, quality policy, quality objectives, quality KPIs, cost of quality, quality performance, or QMR responsibilities. Provide context such as your company type, current quality system status, and specific needs. The skill will guide you through relevant workflows and templates.
Example prompts:
Help me prepare for our quarterly management review. We are a medical device manufacturer.
I need to set quality objectives for the next year. Our current complaint rate is 0.2%.
📄 Output: The skill produces structured guidance, templates, and checklists for management reviews, KPI frameworks, quality objectives, culture assessments, and regulatory compliance monitoring.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/quality-manager-qmr .claude/skills/quality-manager-qmrSkill source: ra-qm-team/skills/quality-manager-qmr/SKILL.md
⚠️ Good to know
The skill is a framework and does not replace actual regulatory expertise or legal advice; users must ensure compliance with specific applicable regulations and standards.
❓ FAQ
What is the minimum frequency for management reviews?
Management reviews must be conducted at least annually, but typically quarterly or semi-annually.
Who are the required attendees for a management review?
Required attendees include the CEO/General Manager, QMR (chair), Department Heads, RA Manager, Production Manager, and Customer Quality.
What are the core quality KPIs mentioned?
Core KPIs include First Pass Yield, Nonconformance Rate, CAPA Closure Rate, CAPA Effectiveness, Finding Closure Rate, Repeat Finding Rate, Complaint Rate, and Satisfaction Score.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.