Single Course ISO 13485 – Medical Devices Medical Devices

ISO 13485:2016 Medical Device Internal Auditor (TPECS)

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard and the principles and practices of effective internal auditing according to ISO 19011:2026 guidelines.

3 Days Virtual Class English Identifier: 152418132
ISO 13485:2016 Medical Device Internal Auditor (TPECS)

Course Overview

What you'll learn

  • Understand the structure, scope, and purpose of ISO 13485:2016.
  • Learn the principles and practices of effective internal audits as per ISO 19011:2026.
  • Develop the ability to plan, conduct, report, and follow-up on internal audits.
  • Gain insights into auditing techniques and auditor competencies.
  • Understand how to assess compliance with ISO 13485:2016 requirements and identify areas for improvement.

Who This Course Is For

Who Should Attend:

  • Quality managers and professionals involved in medical device quality management.
  • Internal auditors and audit team members.
  • Regulatory affairs specialists.
  • Individuals responsible for maintaining and improving the quality management system.
  • Those seeking to enhance their auditing skills and knowledge of ISO 13485:2016

About this course

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485:2016 standard and the principles and practices of effective internal auditing according to ISO 19011:2026 guidelines. The course focuses on the application of ISO 13485:2016 requirements to ensure the quality and safety of medical devices, equipping auditors with the necessary skills to evaluate and improve their organization's quality management system. Participants will learn through a mix of formal tutorials, practical exercises, role-playing scenarios, and group discussions.

 SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:

  • MD - Medical Devices Quality Management Systems
  • AU – Auditing Management Systems

Important Notes:

  • We recommend that you turn your camera on during the course to enhance engagement and participation.

  • For the course exam, all learners are required to keep their camera on for the entire duration of the exam.

  • Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.

  • Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

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