Quality Manager (QMR)
Senior Quality Manager Responsible Person for HealthTech.
$skillfish add ~skills/quality-manager-qmr Real Conversations
See how the Quality Manager (QMR) skill responds to actual requests. These are representative examples of what your AI agent will produce.
I'm the Quality Manager Responsible (QMR) at a 30-person MedTech startup. Our management review is due this month — it's required for ISO 13485. I've never run one before. What does it need to cover and what records do I need?
Management Review — ISO 13485 §5.6 Requirements
The management review is a mandatory top management meeting where you assess the effectiveness of the entire QMS. It requires top management participation (CEO/MD or their direct delegate).
Required inputs per ISO 13485 §5.6.2:
| Input | What to present | Data source |
|---|---|---|
| Follow-up from previous review | Status of actions from last year | Action log |
| Customer feedback | Complaint volume, types, trends | Complaint register |
| Process performance & product conformity | Nonconformance rates, QC data | NCR register |
| Status of CAPAs | Open CAPAs, overdue, effectiveness results | CAPA register |
| Internal and external audit results | Findings, NCs, trends | Audit reports |
| Changes affecting QMS | New regulations (MDR updates), product changes, org changes | RA team input |
| New/revised regulatory requirements | Changes to ISO 13485, MDR, national laws | RA team |
| Recommendations for improvement | From staff, audit findings | QA team |
Required outputs per ISO 13485 §5.6.3:
- Decisions and actions related to maintaining QMS effectiveness
- Product improvement related to customer requirements
- Resource needs identified
Meeting format:
- Attendees: CEO/MD, QMR (you), heads of R&D, Operations, RA, Sales
- Duration: 2–4 hours for a company your size
- Minutes: Must be taken and retained as a QMS record
Minutes template structure:
Date: [Date] Location: [Location]
Attendees: [Name, Role] × N
Chair: [QMR name]
1. Review of previous actions — [status of each]
2. QMS performance summary — [dashboard data]
3. Customer feedback review — [complaint trends]
4. CAPA status — [open items, overdue, effectiveness]
5. Audit findings review
6. Regulatory update — [any changes since last review]
7. Decisions and action items:
| Action | Owner | Due date |
|---|---|---|
Approved by: [CEO signature] Date: [Date]
Common mistake: Treating it as a box-ticking exercise with no real actions. Auditors look for evidence that management reviews data, makes decisions, and follows through. If last year's actions are still open, that's a finding.
Want me to generate the full management review presentation template with required data tables?
Get Started
How to install and use this skill in your preferred environment.
Skills are designed for AI coding agents (Claude Code, Cursor, Windsurf) and IDE-based workflows where the agent can read files, run scripts, and act on your codebase. Web-based AI can use the knowledge and frameworks, but won't have tool access.
Models & Context
Which AI models and context windows work best with this skill.
Recommended Models
Larger models produce more detailed, production-ready outputs.
Context Window
This skill's SKILL.md is typically 3–10 KB — fits in any modern context window.
All current frontier models (Claude, GPT, Gemini) support 100K+ context. Use the full window for complex multi-service work.
Pro tips for best results
Be specific
Include numbers — users, budget, RPS — so the skill can size the architecture.
Share constraints
Compliance needs, team size, and existing stack all improve the output.
Iterate
Start with a high-level design, then ask follow-ups for IaC, cost analysis, or security review.
Combine skills
Pair with companion skills below for end-to-end coverage.
Ready to try Quality Manager (QMR)?
Install the skill and start getting expert-level guidance in your workflow — any agent, any IDE.
$skillfish add ~skills/quality-manager-qmr