Does it cover process validation like IQ/OQ/PQ?

Yes, the skill contains detailed workflows and documentation requirements for the validation of special processes per ISO 13485 standards.

Can I use this for document numbering and change control?

Absolutely. The skill includes a standardized document numbering convention and change control workflow to ensure compliance with Clause 4.2.3.

Does this skill help with ISO 13485:2016 certification?

Yes, it provides a complete implementation roadmap, gap analysis tools, and audit preparation workflows to help organizations achieve and maintain certification.

How does it assist with internal audits?

It provides a framework for planning annual audit programs, executing individual audits, classifying findings (Major/Minor), and generating compliant reports.

Quality Manager - QMS ISO 13485

Name: Quality Manager - QMS ISO 13485
Author: alirezarezvani

byalirezarezvani

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9,958

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Productivity & Workflow

Implements and maintains ISO 13485:2016 Quality Management Systems for medical device organizations through structured documentation and compliance workflows.

This skill acts as a comprehensive specialist for medical device quality management, guiding organizations through the entire ISO 13485:2016 lifecycle. It provides detailed workflows for QMS implementation, document control, internal auditing, and process validation (IQ/OQ/PQ). Whether you are conducting a gap analysis, preparing for a certification audit, or managing supplier qualifications, this skill ensures all regulatory documentation and corrective actions align with international medical device standards and safety requirements.

Key Features

01Structured document control and standardized numbering systems

029,958 GitHub stars

03Internal audit planning, execution, and finding classification

04End-to-end ISO 13485:2016 QMS implementation and gap analysis

05Comprehensive supplier qualification and performance monitoring

06Process validation frameworks covering IQ/OQ/PQ requirements

Use Cases

01Preparing for an ISO 13485 certification or surveillance audit

02Setting up a new Quality Management System for a medical device startup

03Managing CAPA workflows and regulatory document change controls

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add alirezarezvani/claude-skills quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT

Key Features

01Structured document control and standardized numbering systems

029,958 GitHub stars

03Internal audit planning, execution, and finding classification

04End-to-end ISO 13485:2016 QMS implementation and gap analysis

05Comprehensive supplier qualification and performance monitoring

06Process validation frameworks covering IQ/OQ/PQ requirements

Use Cases

01Preparing for an ISO 13485 certification or surveillance audit

02Setting up a new Quality Management System for a medical device startup

03Managing CAPA workflows and regulatory document change controls

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add alirezarezvani/claude-skills quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT