For organizations providing medical devices and related services, ISO 13485:2016 specifies requirements for a quality management system enabling them to consistently meet customer and applicable regulatory requirements. Use this self-assessment checklist for internal audits to determine if your organization’s QMS is aligned with the ISO 13485:2016 standard and evaluate your readiness for a third-party ISO 13485:2016 certification audit.
4. Management reviews examine suitability and effectiveness of quality systems, improvements needed because of customer requirements, and resource needs? (ISO 13485:2016: 4.1.3(c), 5.6.1, 5.6.3, 6.1, 8.4)
5. Management review addresses audit results, customer feedback, process performance, Corrective and Preventive Actions (CAPAs), previous management reviews, changes to QMS, recommendations for improvement, and new or revised regulatory requirements? (ISO 13485:2016: 5.6.2)
19. Executive management ensures adequate and effective quality system is implemented? Ensure management is committed to and communicates importance of meeting customer requirements, regulatory requirements, and QMS. (ISO 13485:2016: 5.1(a), 5.2, 5.5.3)