Quality Manager Qmr

Built for HealthTech and MedTech QMR roles under ISO 13485. This handles the table stakes: prepping management reviews with all the required inputs from Clause 5.6, tracking quality KPIs like first pass yield and CAPA effectiveness, and documenting accountability matrices for Notified Body inspections. The workflow templates are thorough, covering everything from audit scheduling to customer complaint trending. It's structured more like a compliance handbook than a conversational agent, which honestly makes sense given FDA and regulatory bodies expect specific evidence trails. If you're running a quality system and need the documentation framework locked down, this gives you the scaffolding.

skills.sh installs: 121
GitHub stars: 1.1K
last updated: Aug 21, 2026

View on GitHub

Install

$ npx -y skills add borghei/claude-skills --skill quality-manager-qmr --agent claude-code

Installs into .claude/skills of the current project.

Files

Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.

QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements

Responsibility	Scope	Evidence
QMS effectiveness	Monitor system performance and suitability	Management review records
Reporting to management	Communicate QMS performance to top management	Quality reports, dashboards
Quality awareness	Promote regulatory and quality requirements	Training records, communications
Liaison with external parties	Interface with regulators, Notified Bodies	Meeting records, correspondence