Quality Manager Qms Iso13485

This walks you through ISO 13485 QMS implementation with actual workflows and templates. You get gap analysis matrices, document numbering conventions, internal audit checklists, and CAPA management structures. It's built around the standard's clause requirements, so if you're facing a certification audit or building quality systems for medical devices, the structured approach is helpful. The tables are thorough, covering everything from document control approval hierarchies to auditor qualification criteria. It assumes you know why you need ISO 13485 compliance and focuses on the mechanics of getting there, which is exactly right for this domain.

skills.sh installs: 122
GitHub stars: 1.1K
last updated: Aug 21, 2026

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$ npx -y skills add borghei/claude-skills --skill quality-manager-qms-iso13485 --agent claude-code

Installs into .claude/skills of the current project.

Files

Quality Manager - QMS ISO 13485 Specialist

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations. Covers the full lifecycle from gap analysis through certification, plus the FDA QMSR transition (effective Feb 2026), digital/electronic QMS, and AI-enabled device considerations.

Core Capabilities

QMS implementation — gap analysis, Quality Manual (Clause 4.2.2), the 6 mandatory documented procedures, four-tier document hierarchy, certification readiness
Document control — numbering conventions, change control, review schedules, electronic document management (eDMS)
Internal audit — annual audit programs, individual audit execution, auditor qualification, finding classification (Clause 8.2.4)
Process validation — IQ/OQ/PQ protocols, revalidation triggers, special-process examples (Clause 7.5.6)
Supplier qualification — A/B/C categorization, scored evaluation, monitoring, software/cloud provider assessment (Clause 7.4)
Cross-framework integration — FDA QMSR, 21 CFR Part 11 / EU Annex 11, ISO 42001 (AI), remote/hybrid audits, cybersecurity-driven CAPA