Provides expert guidance for ISO 13485 internal audits and medical device quality management system compliance.
The QMS Audit Expert skill provides a comprehensive methodology for medical device manufacturers to plan, execute, and document internal audits in compliance with ISO 13485. It guides users through risk-based audit scheduling, offers clause-specific audit questions, and implements a standardized finding classification system for Major and Minor nonconformities. By integrating CAPA verification and external audit preparation protocols, this skill ensures that quality management systems remain robust and ready for regulatory inspections or certification body audits.
주요 기능
010 GitHub stars
02ISO 13485 clause-specific audit checklists and evidence guides
