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
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.
Participating Organizations at the ISO 9000 World Conference
Department of Commerce
Environmental Protection Agency
Schindler Elevator Corporation
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