Quality Manager Qmr
Run ISO 13485 Clause 5.6 management reviews with the right inputs, agenda, outputs, and action tracking for a regulated QMS.
Overview
Quality Manager QMR is an agent skill for the Operate phase that structures ISO 13485 management reviews, inputs, outputs, and action tracking.
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-manager-qmrWhat is this skill?
- ISO 13485:2016 Clause 5.6 frequency, participants, and record requirements in one table
- Three-tier review cadence: semi-annual full, quarterly quality, monthly operational updates
- Planning checklist for scheduling, inputs, presentations, and attendee logistics
- Structured agenda tying required inputs to required outputs and documentation
- Action tracking workflow so prior review commitments carry forward
- ISO 13485 Clause 5.6 management review requirements table
- Three review types: full semi-annual/annual, quarterly, and monthly cadences
Adoption & trust: 713 installs on skills.sh; 17.5k GitHub stars; 2/3 security scanners passed (skills.sh audits).
What problem does it solve?
You must run defensible management reviews on a schedule but lack a Clause 5.6 checklist, agenda, and action log template.
Who is it for?
Small regulated teams (medical device, diagnostic SaaS) with a designated QMR who need consistent semi-annual or quarterly review documentation.
Skip if: Typical indie web apps with no QMS obligation, or teams that only want generic retrospectives without ISO traceability.
When should I use this skill?
Preparing or conducting ISO 13485 management reviews, drafting QMR agendas, or maintaining review action logs.
What do I get? / Deliverables
You get a review-ready agenda, documented decisions, and tracked actions aligned to ISO 13485 expectations for the next audit cycle.
- Management review agenda and input summary
- Documented outputs and decisions
- Action tracking list with owners and status
Recommended Skills
Journey fit
Management review is an ongoing QMS governance ritual after the product is in market, which maps to running and improving production quality systems. Iterate fits periodic leadership review cycles that close the loop on CAPAs, metrics, and QMS effectiveness—not one-off launch tasks.
How it compares
Use for ISO 13485 management review structure—not a substitute for a full CAPA or internal-audit skill package.
Common Questions / FAQ
Who is quality-manager-qmr for?
Quality managers, founders acting as QMR, and department leads at organizations maintaining an ISO 13485 quality management system.
When should I use quality-manager-qmr?
Use it in Operate when planning quarterly or semi-annual reviews, preparing Clause 5.6 inputs, or updating action status from the last management review.
Is quality-manager-qmr safe to install?
It is documentation guidance only; review the Security Audits panel on this page and treat any agent-generated QMS records as drafts for human approval.
SKILL.md
READMESKILL.md - Quality Manager Qmr
# Management Review Guide ISO 13485 Clause 5.6 management review requirements, inputs, outputs, and action tracking. --- ## Table of Contents - [Review Requirements](#review-requirements) - [Required Inputs](#required-inputs) - [Review Agenda](#review-agenda) - [Required Outputs](#required-outputs) - [Action Tracking](#action-tracking) - [Documentation Templates](#documentation-templates) --- ## Review Requirements ### ISO 13485:2016 Clause 5.6 | Requirement | Specification | |-------------|---------------| | Frequency | Planned intervals (typically quarterly or semi-annually) | | Participants | Top management involvement required | | Documentation | Records must be maintained | | Inputs | All required inputs must be reviewed | | Outputs | Decisions and actions documented | ### Review Schedule | Review Type | Frequency | Focus | Participants | |-------------|-----------|-------|--------------| | Full Management Review | Semi-annual or Annual | Complete QMS performance | CEO, QMR, all department heads | | Quarterly Quality Review | Quarterly | Key metrics and actions | QMR, Quality team, affected managers | | Monthly Quality Update | Monthly | Operational metrics | QMR, Quality team leads | ### Planning Checklist - [ ] Review date scheduled and communicated - [ ] Previous review actions status updated - [ ] All input data collected and analyzed - [ ] Presentation/report prepared - [ ] Attendee availability confirmed - [ ] Meeting room and resources arranged - [ ] Agenda distributed 1 week in advance --- ## Required Inputs ### ISO 13485 Required Input Topics | Input | Source | Data Period | Responsible | |-------|--------|-------------|-------------| | Audit results | Internal and external audits | Since last review | QA Manager | | Customer feedback | Complaints, surveys, returns | Since last review | Customer Quality | | Process performance | Process metrics, yields | Since last review | Process owners | | Product conformity | Inspection data, NCRs | Since last review | QC Manager | | CAPA status | Open/closed CAPAs | Current status | CAPA Officer | | Previous review actions | Action item tracker | Since last review | QMR | | Changes to QMS | Regulatory, standard changes | Since last review | RA Manager | | Recommendations | Improvement opportunities | Ongoing collection | All managers | ### Input Data Collection Template ``` MANAGEMENT REVIEW INPUT SUMMARY Review Period: [Start Date] to [End Date] Prepared By: [Name] Date Prepared: [Date] 1. AUDIT RESULTS Internal Audits Completed: [Number] External Audits Completed: [Number] Major Findings: [Number] | Minor Findings: [Number] Open Audit Actions: [Number] Summary: [Brief narrative] 2. CUSTOMER FEEDBACK Total Complaints: [Number] Complaint Rate: [X per 1000 units] Customer Satisfaction Score: [Score] Top Complaint Categories: - [Category 1]: [Count] - [Category 2]: [Count] Trend: [Improving/Stable/Declining] 3. PROCESS PERFORMANCE | Process | Target | Actual | Status | |---------|--------|--------|--------| | [Process 1] | [Target] | [Actual] | [Met/Not Met] | 4. PRODUCT CONFORMITY First Pass Yield: [%] Nonconformance Rate: [%] Reject/Scrap Cost: [$] Top NC Categories: - [Category 1]: [Count] 5. CAPA STATUS Open CAPAs: [Number] Overdue CAPAs: [Number] Effectiveness Rate: [%] Average Closure Time: [Days] 6. PREVIOUS ACTIONS Total Actions from Last Review: [Number] Completed: [Number] | In Progress: [Number] | Overdue: [Number] 7. QMS CHANGES Regulatory Changes: [List] Standard Updates: [List] Internal Changes: [List] 8. RECOMMENDATIONS [List improvement opportunities collected] ``` ### Data Analysis Guidelines | Input | Analysis Required | Red Flags | |-------|------------------|-----------| | Audit results | Trend by area, repeat findings | Major NC in same area twice | | Complaints | Pareto analysis, rate trending | Increasing rate, safety issues | | Process performance | Control charts, capability | Out of control, Cpk <1.33 | | Product conformit