quality-manager-qms-iso13485

Community

ISO 13485 QMS implementation lead.

Authorovachiever
Version1.0.0
Installs0

System Documentation

What problem does it solve?

Implement and maintain ISO 13485-compliant QMS, including document control, management reviews, internal audits, and CAPA.

Core Features & Use Cases

  • QMS design, documentation, and process mapping
  • Document control lifecycle and change management
  • Internal audit planning, execution, and CAPA
  • Management review preparation and follow-up

Quick Start

Start with a gap analysis, define the quality manual, and begin documenting processes per clause mapping.

Dependency Matrix

Required Modules

None required

Components

scriptsreferencesassets

💻 Claude Code Installation

Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.

Please help me install this Skill:
Name: quality-manager-qms-iso13485
Download link: https://github.com/ovachiever/droid-tings/archive/main.zip#quality-manager-qms-iso13485

Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
View Source Repository

Agent Skills Search Helper

Install a tiny helper to your Agent, search and equip skill from 471,000+ vetted skills library on demand.