How to Audit to the Combined ISO 9001:2015 and 13485:2016 Standards

Presenter: Nancy Pasquan, President, Eyes On, Inc., Escondido, CA, USA

Keywords: Medical Devices, Integrated Audits, Multiple Standards

Industry: Food/Drug/Cosmetics, Manufacturing, Software

Level: Intermediate


I do certification audits for ISO 13485:2016 and ISO 9001:2015. Most often I audit the two standards together (at the same time). Some companies I audit make and market medical devices and others manufacture components of medical devices. Some are subject to FDA scrutiny. In this presentation, I will describe my approach to the audits and tell you what I ask to see and what I am looking for in terms of evidence of compliance with the standards. I will go over how the updated standards are being interpreted in the industry and how that interpretation may affect the audit.