ISO 13485 w/ QMSR Pre-Audit Checklist
Prepare your medical device quality management system for an audit with a practical checklist designed to help identify potential gaps before they become findings.
The APEX Quality Assurance ISO 13485 w/ QMSR Pre-Audit Checklist provides a structured framework for reviewing your Quality Management System against applicable ISO 13485 requirements and the FDA Quality Management System Regulation (QMSR). It helps medical device organizations evaluate their processes, documentation, and quality controls before an internal, certification, or regulatory audit.
Use the checklist to systematically review key areas of your QMS, identify potential areas of concern, and verify that processes are implemented and supported by appropriate evidence.
What’s included:
- ISO 13485 and QMSR-focused pre-audit checkpoints
- Structured questions for evaluating QMS requirements
- Review of documented information and quality records
- Management responsibility and quality objectives
- Risk management and product realization processes
- Design and development controls
- Purchasing and supplier controls
- Production and process controls
- Identification and traceability
- Monitoring, measurement, and product verification
- Internal audits and management review
- Nonconformity and corrective action
- Continual improvement and QMS effectiveness
- Space to document findings, observations, and areas requiring attention
Whether you’re preparing for a QMSR inspection, ISO 13485 audit, certification activity, or internal readiness review, this checklist gives your team a practical way to evaluate your QMS and address potential issues before an auditor or regulator does.
Important: This checklist is a practical audit-readiness tool and does not replace ISO 13485, the FDA QMSR, applicable FDA requirements, or the requirements of your certification or regulatory body.