What does the ISO 13485 Quality Manager skill do?

It provides specialized guidance and automated tools for implementing and maintaining a Quality Management System (QMS) specifically for the medical device industry, following ISO 13485:2016 standards.

Can this skill help with FDA 21 CFR 820 compliance?

Yes, the skill is designed to align ISO 13485 requirements with other major regulatory frameworks, including FDA 21 CFR 820 (QSR) and MDR Article 10.

Does it provide templates for Quality Manuals?

Yes, it includes references and assets for Quality Manuals, SOPs, work instructions, and design control templates.

How does it assist with internal audits?

The skill includes automated scripts and checklists for conducting process, system, and product audits, helping you identify gaps and verify QMS effectiveness.

Is risk management covered?

Absolutely. It integrates ISO 14971 risk management workflows directly into the QMS processes, including risk analysis, evaluation, and control.

Senior Quality Manager - ISO 13485

Name: Senior Quality Manager - ISO 13485
Author: alirezarezvani

byalirezarezvani

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1,040

Productivity & Workflow

Automates ISO 13485 Quality Management System (QMS) implementation, maintenance, and regulatory compliance for medical device organizations.

About

This skill acts as an expert-level specialist for medical device organizations seeking to establish or maintain a robust Quality Management System. It provides end-to-end guidance through the QMS lifecycle, including gap analysis, the creation of Quality Manuals and SOPs, and the facilitation of management reviews. By integrating ISO 14971 risk management and design controls, the skill helps teams streamline document control workflows, execute risk-based internal audits, and manage corrective actions (CAPA) to ensure continuous regulatory readiness and ISO 13485:2016 certification maintenance.

Key Features

ISO 13485:2016 QMS design and comprehensive documentation generation
Automated document control lifecycle management and versioning workflows
Risk-based internal audit planning with process-specific checklists
Integration of ISO 14971 risk management across the product lifecycle
Automated management review preparation and quality performance metrics
1,040 GitHub stars

Use Cases

Preparing a medical device startup for initial ISO 13485 certification audits
Automating the creation of Standard Operating Procedures (SOPs) and work instructions
Executing internal audits and managing the CAPA process for non-conformities

About

Key Features

ISO 13485:2016 QMS design and comprehensive documentation generation
Automated document control lifecycle management and versioning workflows
Risk-based internal audit planning with process-specific checklists
Integration of ISO 14971 risk management across the product lifecycle
Automated management review preparation and quality performance metrics
1,040 GitHub stars

Use Cases

Preparing a medical device startup for initial ISO 13485 certification audits
Automating the creation of Standard Operating Procedures (SOPs) and work instructions
Executing internal audits and managing the CAPA process for non-conformities