quality-manager-qms-iso13485

Establish ISO 13485:2016 compliant QMS with templates and workflows.

Updated Apr 16, 2026

Search Tags:#documentation #audit #compliance #iso13485 #qms #medical-device #capa

Ready to run

npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill quality-manager-qms-iso13485-devcharuzu

💬 Prompt for ChatGPT / Claude Chat▼

Please help me install this Agent Skill.
Skill: quality-manager-qms-iso13485
Source: https://github.com/devCharuzu/philfida-taskmanage/tree/main/.windsurf/skills/quality-manager-qms-iso13485
Command: npx skills add https://github.com/devCharuzu/philfida-taskmanage --skill quality-manager-qms-iso13485-devcharuzu

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

ISO 13485:2016 compliance and ongoing quality management for medical device organizations can be challenging due to fragmented processes, missing documentation, and unprepared audits.

The Skill provides a comprehensive framework to design, implement, and maintain a compliant QMS, covering documentation control, internal audits, CAPA, supplier qualification, and record retention to support regulatory certification and ongoing compliance.

Core Features & Use Cases

QMS design and governance aligned to ISO 13485:2016 requirements
Documentation control, record retention, and change management templates
Internal audit planning, CAPA management, supplier qualification, and management review workflows
Use Case: A medical device startup saving time by implementing a ready-to-use QMS scaffold and audit-ready documentation for regulatory submissions

Quick Start

Define your QMS scope and begin organizing critical processes and procedures using the provided templates and workflows.

Frequently Asked Questions about quality-manager-qms-iso13485

High-intent search queries and answers about installing and using this skill.

FAQPage Schema

How do I set up an ISO 13485 QMS for a medical device startup?▼

To establish an ISO 13485 QMS, define your QMS scope and use ready-to-use templates to organize documentation control, risk management, and process procedures for regulatory submissions and certification.

What is included in ISO 13485 audit preparation?▼

ISO 13485 audit preparation includes internal audit planning, CAPA management, supplier qualification, and management review workflows to ensure your medical device organization meets regulatory compliance standards.

How do I manage CAPA and documentation control for medical device compliance?▼

Manage CAPA and documentation control for medical device compliance by applying structured workflows and templates for change management, record retention, and corrective actions aligned with ISO 13485:2016 requirements.

Can I use this to establish supplier qualification and management review workflows?▼

Yes, you can establish supplier qualification and management review workflows using provided templates that satisfy ISO 13485:2016 policy requirements, process control, and ongoing quality management governance.

Does this provide templates for ISO 13485 record retention and change management?▼

Yes, this provides templates for ISO 13485 record retention and change management, allowing you to maintain documentation control and satisfy quality management system compliance for medical device regulatory submissions.