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ISO 13485:2016 Medical Devices—Quality Management Systems (Virtual)


ISO 13485:2016 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes LEAD AUDITOR, Exemplar Global Certified Course

Litts Quality Technologies, Inc. will be conducting this 4-day class virtually via a Zoom live, interactive meeting.


This is a 4-day class split over two weeks.

8:30am – 4:30pm • Wednesday, May 26th

8:30am – 4:30pm • Thursday, May 27th

8:30am – 4:30pm • Wednesday, June 2nd

8:30am –4:30pm • Thursday, June 3rd

Prior to the course you will be emailed the necessary Zoom meeting link. This will require a computer or mobile phone in order to access. Availability to have a camera and microphone is required.

Who Should Attend:

  • Quality Managers
  • Regulatory Managers
  • Current Internal Auditors
  • Potential Internal Auditors
  • Auditors who want to start the process of becoming Third-Party Auditors
  • Purchasing employees
  • Any team member of an organization that is registered to or wants to become registered to ISO 13485:2016 to gain an understanding of the requirements.

Please register on-line here, or email, or call 1-877-LQT-6001 {1-877-578-6001}. If you have any questions regarding this information please feel free to contact us.



The major objective of this course is to provide knowledge in the method of Leading Quality Management System (QMS) audits using the Process Approach auditing method. Attendees will also be able to apply their learned knowledge in leading improvement of their organization audit process.

The attendees will be able to function as Lead Internal (First Party) or Interested party (Second Party) auditors. In addition, this will provide knowledge to begin the process of becoming a Certified Body (Third-party) auditor.

Exercises and quizzes are used to help with the understanding of the ISO 13485:2016 Standard and Process Based Auditing Techniques.

Added benefit of taking this Certified Course:

Attendees will Receive from Exemplar Global

  • 12 months of ongoing professional development and support through direct access to a series of tailored learning content
  • Exemplar Global Graduate personnel certification to enhance their employment potential
  • Access to complete the Work Style Assessment self-coaching tool for professional growth
  • Access to an exclusive LinkedIn community to interact with other graduates and industry professionals to promote networking opportunities and skill sharing
  • Continuing professional development opportunities through access to webinars, online articles, and events
  • Greater support on their career path



  • Introductions
  • Course Objectives and Requirements
  • An overview of Exemplar Global
  • An overview of the International Organization for Standardization (ISO) and available resources offered
  • The Strategic Direction and Context of an organization
  • The Concepts and Language used in the Standards
  • The goals and objectives of the ISO 13485:2016 Medical Device—Quality Management Systems—Requirements for Regulatory Purposes Standard, ISO 9000:2015 Quality Management Systems—Fundamentals and Vocabulary and ISO 9004:2018 Quality Management—Quality of an Organization—Guidance to achieve Sustained Success Family of Standards
  • Concepts and language
  • Definitions
  • Begin the detailed review of ISO 13485:2016 Standard Clauses with exercises through-out


  • Quiz
  • Continuing review of the detailed requirements of the ISO 13485:2016 Standard Clauses
  • The concepts of auditing using the Process Approach based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  • The terms and definitions used in auditing
  • The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
  • Review of an Audit Procedure and related forms


    • Quiz
    • Continuing review of The Six Steps of Auditing Activities based upon ISO 19011:2018 Guidelines for Auditing Management Systems
    • GMP’s
    • Risk Management
    • Review of an Audit Procedure and related forms
    • Attendees begin review a case study and prepare to perform Mock Process Audits


  • Quiz
  • Perform case study Mock Process Audits
  • Writing audit reports
  • Writing requests for corrective actions
  • How to follow-up and close out Corrective Actions
  • Complete the Exemplar Global Work Style Assessment self-coaching Tool (Note: Will need the ability to be able to access the Exemplar Global website – a link will be provided)
  • Final Test
  • Course Evaluation


Litts Quality Technologies, Inc. will provide a:

  • Student Workbooks (electronic, hardcopy, or a combination of both sent to you following registration)
  • Certificates


Attendees are required to obtain a copy of the ISO 13485:2016 standard and review prior to attending the course. This will help with navigating through the standard during the sessions. In addition, attendees need to bring the copy to the class.

It is also highly recommended, (but not necessary to attend the class) that the attendees obtain a copy of the ISO 19011:2018 Guidelines for Auditing Management Systems and bring it to the class.


A final test is administered the last day to evaluate the acquired knowledge and determine the effectiveness of the course program as required by management system standards.


$1,675.00 per attendee.

A 5% discount is offered for 3 or more attendees from the same organization registered at the same time. Email to obtain promo code.

You must sign up by May 20th in order to have time to receive the course materials.


Credit Card Payment or Check (received prior to the first day of the training class) are accepted.


All cancellations must be received by MAY 20, 2021. After that date, any payments cannot be refunded. However, alternate attendee(s) may take the course in place of the person(s) who originally enrolled.

Litts Quality Technologies, Inc. reserves the right to cancel the training program should sufficient enrollment not be achieved by the cut-off date and shall not be responsible for any attendee costs associated with cancelled transportation or accommodation reservations.

Price: $1,675.00

Start Time: 8:30 am
End Time: 4:30 pm

Start Date: May 26, 2021
End Date: June 3, 2021

Registration Details

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