How does it assist in nonconformity management?

The skill provides a systematic classification system (Major, Minor, Observation) and integrates directly with CAPA processes to ensure findings are translated into effective corrective actions.

Does it include templates for audit planning?

Yes, the skill references a library of scripts and assets including audit-prep checklists, schedule optimizers, and standardized report templates to automate documentation.

Can this skill help with FDA or EU MDR inspections?

Yes, it includes specific frameworks for regulatory inspection preparation, including coordination strategies, mock audit execution, and real-time issue resolution during external assessments.

Which quality standards does the QMS Audit Expert support?

This skill is primarily focused on ISO 13485:2016 for medical devices, but also incorporates principles from ISO 14971 (Risk Management), IEC 62304 (Software), and general ISO 9001 auditing methodologies.

QMS Audit Expert

Name: QMS Audit Expert
Author: pur3v4d3r

bypur3v4d3r

•

Productividad y Flujo de Trabajo

Manages comprehensive Quality Management System audits and ISO 13485 compliance workflows.

Acerca de

The QMS Audit Expert skill provides senior-level expertise for internal and external quality management system auditing, specifically optimized for medical device organizations following ISO 13485. It assists in designing risk-based audit programs, executing systematic process audits, identifying nonconformities, and managing corrective actions (CAPA). Whether preparing for a regulatory inspection or optimizing internal quality processes, this skill provides the frameworks, checklists, and methodologies needed to ensure continuous improvement and strict regulatory compliance.

Características Principales

ISO 13485 risk-based audit planning and scheduling
Comprehensive nonconformity identification and classification
1 GitHub stars
Regulatory inspection readiness (FDA, EU MDR) and coordination
Integrated CAPA verification and effectiveness assessment
Process-based audit methodology for core QMS functions

Casos de Uso

Conducting detailed supplier or design control audits to ensure supply chain quality
Preparing internal teams for an upcoming ISO 13485 certification body audit
Developing a risk-based annual internal audit schedule for medical device manufacturing

Acerca de

Características Principales

ISO 13485 risk-based audit planning and scheduling
Comprehensive nonconformity identification and classification
1 GitHub stars
Regulatory inspection readiness (FDA, EU MDR) and coordination
Integrated CAPA verification and effectiveness assessment
Process-based audit methodology for core QMS functions

Casos de Uso

Conducting detailed supplier or design control audits to ensure supply chain quality
Preparing internal teams for an upcoming ISO 13485 certification body audit
Developing a risk-based annual internal audit schedule for medical device manufacturing