ISO 13485:2016 Internal Auditor Training

IQC’s “ISO 13485:2016 Internal Auditor” competency-based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2018 , “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through internal audits that are required for a quality management system based on ISO 13485:2016. Our qualified instructors will also help you to boost your audit capabilities. Students gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, group workshops, open forum discussions, and an on-site practice audit.


Cost: Members $950   •   Non-Members $1200

Upcoming Open Enrollment Classes:
None scheduled at this time, please contact us about future classes.

This training can also be done on-site at your location with a minimum of 6 attendees, no more than 11. Call us today about the possibilities!


Learning Objectives:

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 13485:2016 standard
  • Apply ISO 19011: 2018 concepts, new terminology and guidelines
  • Understand the types of risks and opportunities associated with auditing.
  • Understand the roles and responsibilities of the auditor
  • Conduct all phases of an internal audit adopting a risk-based approach

Time: 3 days (8:00 AM to 5:00 PM)

Target Audience:  Individuals interested in conducting, managing, or participating in first-party (internal) audits.

Purchase of the AS9100  standard is required for this course. If you do not currently have one, the ASQ website is a good source at www.asq.org.


Cancellation Policy
Classes are subject to cancellation if registration is insufficient.  If cancelled the registrant is entitled to a full refund OR having your registration forwarded to the next scheduled class.  Cancellation by the registrant within 2 weeks of the class date will result in a 50% refund.