Course Overview:

This highly participative course begins with a high-level overview of the differences between ISO 9001:2015 and ISO 9001:2008. Practical workshops and case studies help students understand and apply the new requirements of the ISO 9001:2015 standard. Learn the steps to take now to ensure a successful transition to ISO 9001:2015. This course also includes "Ask the Assessor" where students can gain valuable insight into what lead assessors and auditors are looking for and get practical real-world advice, best practices, and tips.

Discussion Topics:

  • Overivew of ISO 9001:2015 Standard
  • Highlevel overview of the diffences between ISO 9001:2015 and ISO 9001:2008
  • Understanding the key elements and importance of a gap assessment
  • Transition Planning
  • Important QMS Updates
  • Ask the Assessor

Student Prerequisites:  Each student shall be required to have studied the most newly revised version of ISO/IEC 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.


  • Gain insight and best practice advice and tips


This course is acceptable for all staff who participate in the operation of the quality system.

Speaker: Gretchen McAuliffe
Speaker Gretchen McAuliffe
Gretchen McAuliffe is one of the co-founders of Labtopia.  As a Principal, Gretchen oversees operations for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia Informatix.  Gretchen specializes in providing quality assurance support to ISO and GxP manufacturers, laboratories, and distributors.  As a QA professional, she ...
Full Description


At Labtopia Training, we are scientific and technical professionals just like you. Therefore, we understand the unique challenges you face in your workplace.  With over 25 years of industry experience, we understand the importance of consistent, effective training programs.