What is the primary purpose of the ISO 13485 Quality Manager skill?

It is designed to help medical device companies build, maintain, and optimize a Quality Management System (QMS) that complies with ISO 13485:2016 standards.

Can it help with internal audits?

Absolutely. It includes scripts and templates for annual audit planning, execution of process/system/product audits, and nonconformity management.

Is risk management included?

Yes, it integrates ISO 14971 risk management workflows directly into the QMS, covering analysis, evaluation, and post-production information.

Does this skill support FDA and MDR regulations?

Yes, the skill is designed to align QMS processes with FDA 21 CFR 820 (Quality System Regulation) and EU MDR Article 10 requirements.

How does it handle document control?

The skill provides a structured lifecycle framework for document creation, approval, distribution, maintenance, and retention to ensure full traceability.

ISO 13485 Quality Manager

Name: ISO 13485 Quality Manager
Author: BbgnsurfTech

byBbgnsurfTech

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学習とドキュメンテーション

Automates and optimizes ISO 13485 Quality Management Systems (QMS) for medical device compliance and certification.

This skill transforms Claude into a specialized Quality Manager expert in the medical device industry, focusing on ISO 13485:2016 standards. It provides comprehensive support for QMS implementation, document control lifecycle management, internal audit scheduling, and management review preparation. By integrating risk management (ISO 14971) and regulatory requirements like EU MDR and FDA 21 CFR 820, it ensures that organizations maintain high-quality standards and audit readiness throughout the entire product lifecycle, from design controls to post-market surveillance.

主な機能

01Internal audit program design and checklist generation

02Integrated risk management following ISO 14971

03Automated document control lifecycle management

04Management review preparation and KPI tracking

053 GitHub stars

06Full ISO 13485:2016 QMS implementation framework

ユースケース

01Preparing for ISO 13485 certification or annual surveillance audits

02Standardizing design controls and supplier quality management processes

03Establishing a compliant QMS for medical device startups

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add bbgnsurftech/claude-skills-collection quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT

Download Skill