quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.

Run `npx @skills-hub-ai/cli install alirezarezvani-quality-manager-qms-iso13485` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/alirezarezvani-quality-manager-qms-iso13485/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.

quality-manager-qms-iso13485 runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.

Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.

In Claude Code, type `/alirezarezvani-quality-manager-qms-iso13485` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.

Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.