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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.                     

    Call for Proposals

    Proposal Submission Deadline:
    October 11, 2019

    Acceptance notification date:
    November 11, 2019

    Early Registration Deadline:
    February 11, 2020

    Please make sure to review and prepare the material needed before you start the on-line Proposal Submission Form. Click here to see Proposal Submission Guidelines.

    Who May Submit: This online form may be used by a principal speaker, co-speaker, contact person, or a committee member submitting on behalf of a speaker.

    Multiple Proposals: You may submit multiple proposals.

    Conference Registration Fee:
    The conference registration fee is waived for the principal speaker of accepted proposals. Speakers are responsible for their travel expenses and arrangements. Co-speakers will receive a 30% discount for the conference that they are presenting at.

    Length of Presentations: Technical sessions are typically 35 minutes. There will be a limited number of "double" sessions, 70 minutes, at the end of each day.


    You will need the following to submit a proposal

    Proposal Title: Maximum 80 characters including spaces. 

    Keywords:Please include three keywords with a maximum of 100 characters, including spaces. 

    Industry Sector: Please select the most relevant Industry sector for the proposal from a list.

    Abstract: The Abstract should be 1,500 to 5,000 characters (note that it is Characters, NOT words), including spaces.

    Biography: The Biography must be 1,500 to 5,000 characters, including spaces.

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    (*) based on previous conference attendance


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    Tel:  1 (408) 894-9910 or 1(800) 875-1960
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