What problem does it solve? Medical device organizations struggle to plan, execute, and follow up on ISO 13485 quality management system audits while maintaining regulatory compliance and audit program effectiveness. ## Core Features & Use Cases - Risk-Based Audit Planning: Builds annual audit schedules based on process criticality, previous findings, and regulatory changes per ISO 13485 Clause 8.2.2. - Audit Execution & Nonconformity Management: Guides audit preparation, evidence collection, finding classification (major/minor/observation), and CAPA integration with corrective action verification. - External Audit Preparation: Supports regulatory inspections, certification body audits, and customer audits with readiness assessments and mock audit execution. - Use Case: A quality manager at a medical device company needs to prepare for an upcoming notified body recertification audit; the Skill generates a risk-based internal audit schedule, clause-specific checklists, and a nonconformity tracking workflow. ## Quick Start Ask the assistant to create a risk-based internal audit plan for your ISO 13485 quality management system covering design controls and supplier management.
