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ISO 13485 Internal Auditor Training

Certified Internal Auditor Training Course

Learn how to plan and perform internal audits of quality management systems against the requirements of ISO 13485:2016.

Based on our Exemplar Global certified lead auditor course, this class includes workshops tailored to the changing medical device industry and discussions of auditing techniques and best practices with an increased focus on internal audits. Exercises and workshops feature audit criteria from ISO 13485:2016.

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Course Detail

Objectives

  • Understand the core concepts of an effective quality system such as process and risk-based approaches.
  • Learn about the ISO 9000 standard series and how ISO 9001:2015, FDA’s
  • Quality System Regulation, and ISO 13485:2016 requirements are related.
  • Explain how to plan and execute an internal audit, as well as conduct follow-up activities using concept detailed in ISO 19011.
  • Describe what third-party assessors look for when they audit your organization.
  • Practice collecting audit evidence and documenting observations – including using techniques for effective questioning and listening – during course workshops.
  • Describe how to verify the effectiveness and adequacy of corrective action, close out an audit, and conduct follow-up surveillance audits.

Topics

  • The quality management system
  • Analysis and interpretation of ISO 13485
  • Process and risk-based auditing techniques
  • The quality audit cycle
  • Preaudit activities
  • On-site audit activities
  • Report writing—nonconformity reports
  • Corrective action

Who Should Attend

This is a perfect fit if you will be conducting, managing, or participating in internal (first-party) audits, or helping to develop an ISO 13485 quality system. Also great if you are involved in developing, implementing, and/or maintaining an internal audit system that meets the requirements of ISO 13485.

Exemplar Global-Certification

There are two quizzes during the training and a one-hour, open-book final exam on the last day. For training certification, attendees must meet class participation requirements, pass the quizzes and exam, and attend the full session.

This training course is an Exemplar Global certified course. To attain registration as a QMS Auditor/Senior Auditor/Lead Auditor, you must pass the written examination, earn a passing grade in the course assessments, and meet prescribed professional requirements.

Exemplar Global requires that all attendees study the current published version of ISO 13485 before attending the class.

Course Schedule

Virtual Class Days: The first 4 days run daily 1:00-5:00 p.m. ET; the final session runs 11:30 a.m.-5:00 p.m. ET to allow time for administering the final exam.

  • Virtual Half-Days

    5
  • In-Person Full-Days

    3
  • CEUs

    2.5

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Online Training Schedule

  • This class is delivered across 5 consecutive business days.
  • The first 4 days run daily 1:00-5:00 p.m. ET; the final session runs 11:30 a.m.-5:00 p.m. ET to allow time for administering the final exam.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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