What tools are included in this skill?

It features specialized scripts for audit scheduling, preparation checklists, and performance analysis to optimize your quality program.

Can I use this for external audit preparation?

Absolutely. It includes specific frameworks for regulatory inspection readiness, certification body audits, and customer audit coordination.

Does this skill support ISO 13485 compliance?

Yes, it is specifically designed with deep expertise in ISO 13485:2016 requirements and medical device quality standards.

How does it handle nonconformities?

The skill provides a systematic classification system (Major, Minor, Observation) and guides you through documentation and CAPA integration.

QMS Audit Expert

Name: QMS Audit Expert
Author: BbgnsurfTech

byBbgnsurfTech

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セキュリティとテスト

Provides expert-level ISO 13485 quality management system auditing, including risk-based planning, nonconformity identification, and CAPA integration.

概要

The QMS Audit Expert skill transforms Claude into a senior quality management specialist focused on the medical device industry. It provides comprehensive frameworks for designing risk-based internal audit programs, executing systematic process audits, and managing the full lifecycle of nonconformities. Whether you are preparing for a regulatory inspection, optimizing an internal audit schedule, or managing auditor competencies, this skill offers the domain-specific logic, templates, and methodologies required to maintain rigorous compliance with ISO 13485 and global regulatory standards.

主な機能

CAPA Integration and Effectiveness Verification
External Audit and Regulatory Inspection Preparation
Systematic Nonconformity Identification and Classification
ISO 13485 Audit Program Management
3 GitHub stars
Risk-Based Audit Planning and Scheduling

ユースケース

Conducting a mock audit to prepare for an upcoming ISO 13485 certification or FDA inspection.
Developing an annual risk-based internal audit schedule for a medical device manufacturer.
Documenting and classifying audit findings to initiate appropriate corrective and preventive actions.

概要

主な機能

CAPA Integration and Effectiveness Verification
External Audit and Regulatory Inspection Preparation
Systematic Nonconformity Identification and Classification
ISO 13485 Audit Program Management
3 GitHub stars
Risk-Based Audit Planning and Scheduling

ユースケース

Conducting a mock audit to prepare for an upcoming ISO 13485 certification or FDA inspection.
Developing an annual risk-based internal audit schedule for a medical device manufacturer.
Documenting and classifying audit findings to initiate appropriate corrective and preventive actions.