Moving from ISO 9001: 2008 to ISO 9001: 2015, Evolution of the Standard
Since its first publication in 1987, ISO 9001 has been revised several times to remain relevant and in line with the market needs of businesses. A new revision of the standard was launched in September 2015; replacing the latest version published in 2008. With over 1.2 million companies certified around the world, ISO 9001:2015 introduced several changes; some of those are significant as they impact key areas of the companies’ Quality Management System.
The revision of the standard was undertaken to reflect several aspects. One of them was to allow for a better structuring of the standard and facilitate its future evolutions. Through language and definitions, and a consistent approach to quality management, the goal was to develop a more stable framework and environment focusing on key principles to allow for a smoother transition in the eyes of future evolutions.
Topic: Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation
About the presenter: Dr. Julien Sénac is an IVD specialist, Certification Project Manager and Technical Documentation Assessor for LNE/G-MED North America Inc.
Date: Wednesday, June 29th, 2016
Time: 2:00 pm Eastern Time Click here to Register!