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ISO 13485:2016 The Path Forward

Course ID ISO13485PF
Format Classroom

Understand the requirements of ISO 13485:2016 and what they mean for your organization. Learn the steps needed to update your current QMS.

Understand the requirements of ISO 13485:2016 and what they mean for your organization. Learn the steps needed to update your current QMS to meet the requirements of ISO 13485:2016.

You will leave this course with a formal, documented, detailed plan that is specific to the needs of your organization. This plan provides the details you will need to move your organization forward to accomplish two objectives: 1) Meet the requirements of ISO 13485:2016 AND provide evidence that requirements have been met. 2) Achieve the embedded benefits contained in ISO 13485:2016. Benefits will focus on the organization, customers and regulatory bodies.

Learn why the changes are taking place and when they will become official. Understand how the changes will impact your organization and when you should begin working on changes that will enable your organization to meet the new requirements.

Please note that the ISO 13485:2016 Auditor Transition Training and ISO 13485:2016 The Path Forward courses deal with changes contained in the 2016 revision of the standard. There is some overlap in course content.

Students that successfully complete this course may claim to be a certificate holder for ISO 13485:2016 Path Forward. They may not claim to be a certified person.

Course Data

  • CEU Hours: 1.6
  • Length: 16 Hours
  • ASQ RU: 1.6
  • Audience: Practitioner
  • Provider: ASQ - ILT
Course Overview

Learning Objectives:

  • Learn the specific differences between ISO 13485:2003 and ISO 13485:2016.
  • Know alignment requirements between the Quality Management System and regulatory requirements.
  • Understand the steps an organization must take to update their current QMS to meet the requirements of ISO 13485:2016.
  • Cover specific approaches that would allow an organization to resolve the differences between ISO 13485:2003 and ISO 13485:2016 as this relates to the operation of the QMS.
  • Learn the steps an organization must take to update their current QMS to meet the requirements of ISO 13485:2016.
  • Understand how to identify opportunities and achieve value for your organization while implementing ISO 13485:2016.

Who Should Attend:

This course is intended for those who are using ISO 13485:2003 and will be adopting ISO 13485:2016. Those who will receive value from this course include managers and their representatives, senior leaders, regulatory affairs and quality managers, auditors and document control personnel.

Additional Notes

Important: All attendees are required to bring their own copy of both the ISO 13485:2003 and the ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes to this training. Copies will not be provided for you. The 2016 standard can be purchased here.


Student manual and handouts will be provided.

Cancellation Policy
ASQ reserves the right to cancel or re-schedule courses and to change instructors. Please be advised that in the event of a course cancellation, ASQ is not responsible for airfare penalties or other travel related expenses you may incur.
  • If you need to cancel, we will refund your paid registration fee as noted below.
    • Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
    • Requests received within 5 business days of the course starting incur a $150 processing fee.
    • After the course starts, there are no refunds or transfers.
    • Registrants who fail to attend without advance notice are liable for the entire course fee.
    • If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
  • You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.

Enrollment Details

Format: Classroom
Format: Classroom

An instructor-led traditional classroom experience. Classroom-based instruction involves the highest level of instructor/student interaction. We offer classroom style training in two formats. See public and on-site.

No Offerings Scheduled English List: $999 Member: $899



ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.

5 Benefits of On-Site Training

  1. Expertise to your location: Saves time and travel expenses
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