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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

ABSTRACT 

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.                     

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    Conference Chair's Message

    Robert Freeman

    The 2019 ISO 9000 & AUDITS WORLD CONFERENCE is focused on providing you and your organization with the information and tools needed to continue this drive toward excellence. This year’s conference will not only continue to prove relevant topics with leading experts in their respective fields, but it is ...read more