Can it help my team prepare for an FDA inspection?

Absolutely. It includes specialized regulatory inspection guides and readiness assessment tools to ensure your organization is prepared for external scrutiny.

How does it handle audit findings and nonconformities?

The skill provides a standardized classification system for findings and integrates with CAPA processes to track root cause analysis and verify corrective action effectiveness.

Does this skill support the latest ISO 13485 standards?

Yes, the skill is built with comprehensive knowledge of ISO 13485, specifically addressing requirements for internal auditing, risk management, and process-based assessments.

Is there support for risk-based audit planning?

Yes, it includes logic for determining audit frequency and scope based on process criticality, previous audit results, and QMS performance data.

QMS Audit & ISO 13485 Expert

Name: QMS Audit & ISO 13485 Expert
Author: alirezarezvani

byalirezarezvani

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1,039

Security & Testing

Streamlines Quality Management System auditing and ISO 13485 compliance through risk-based planning, nonconformity management, and regulatory inspection preparation.

About

This skill acts as a comprehensive digital consultant for Quality Assurance professionals and auditors operating within the medical device industry. It provides expert-level guidance on the entire audit lifecycle, from designing risk-based annual audit programs to executing process-specific evaluations and managing nonconformities. By integrating ISO 13485 requirements and proven audit methodologies, it helps organizations maintain rigorous compliance, prepare for external regulatory inspections, and drive continuous improvement through systematic CAPA verification and auditor competency management.

Key Features

Automated audit preparation checklists and documentation templates
Systematic nonconformity classification and CAPA integration tracking
Risk-based audit program planning and schedule optimization
Comprehensive ISO 13485 and process-based audit frameworks
Specialized preparation guides for regulatory and certification body audits
1,039 GitHub stars

Use Cases

Preparing internal teams for FDA inspections or ISO 13485 certification body assessments
Conducting specialized audits for high-risk areas like Design Controls or Software Lifecycles
Developing and managing an annual risk-based internal audit schedule for medical device manufacturers

About

Key Features

Automated audit preparation checklists and documentation templates
Systematic nonconformity classification and CAPA integration tracking
Risk-based audit program planning and schedule optimization
Comprehensive ISO 13485 and process-based audit frameworks
Specialized preparation guides for regulatory and certification body audits
1,039 GitHub stars

Use Cases

Preparing internal teams for FDA inspections or ISO 13485 certification body assessments
Conducting specialized audits for high-risk areas like Design Controls or Software Lifecycles
Developing and managing an annual risk-based internal audit schedule for medical device manufacturers