What is an Engineering Audit Like? An ISO 13485 Medical Device Engineering QMS Case Study

Overview
This Medium article by Anna J McDougall walks readers through a real-world engineering audit of a medical device Quality Management System (QMS) certified to ISO 13485. It explains the audit process, common findings, and how engineering teams can prepare and respond effectively.

Key Takeaways

• Audits are opportunities to identify gaps in design controls, risk management, and documentation.
• Preparing checklists aligned with ISO 13485 clauses can streamline the audit.
• Effective communication between engineering, quality, and regulatory teams reduces audit friction.
• Post-audit corrective actions should be tracked in a centralized system.

Who Would Benefit

• Engineering managers overseeing regulated product development.
• Quality assurance leaders managing ISO-based QMS.
• Technical leads looking to improve audit readiness.
• Product developers in the medical device space.

Frameworks and Methodologies

• ISO 13485 (Medical Device Quality Management Systems)
• Design Control processes
• Risk Management (ISO 14971)
• Corrective and Preventive Action (CAPA) workflows