top of page

ISO 13485: 2016 QMSMD Internal Audit


Designed for medical device quality professionals seeking to enhance their existing understanding of ISO 13485:2016 and assess the efficiency of their Quality Management System (QMS), this course focuses on the principles and methodologies of conducting effective audits aligned with ISO 13485:2016 and ISO 19011:2011.

Course Objective 

  • Gain a comprehensive understanding of QMS auditing guidelines as per ISO 13485:2016, covering the entire internal audit process, including initiation, preparation, conducting audit activities, and preparing and distributing audit reports.

  • Learn how to apply a risk-based approach within the medical device QMS and effectively implement it during internal audits.

  • Acquire skills to effectively handle non-conformities identified during the audit process.

  • Enhance your knowledge of fulfilling the requirements of ISO 13485:2016 and supporting the organization in meeting regulatory obligations.

Target Participants 

Internal Auditors, Management, Executive Level , Steering Committee Members.

bottom of page