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  • 1.  ISO 9001 Question

    Posted 17-Jun-2014 08:46
    Hello
    I am looking to begin a medical website on information about health (virtual service) to pitch in the United States. Does anyone know:
    1. anything about how the FDA requires ISO 9001 for virtual services? - any news on this at all?
    2. what certifiying company is the best to use that is most widely recognized in the United States for
    auditing and issuing the ISO 9001? For example BSI.

    Thanks so much
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    Dr. AlexAndria Kung PHD,MPH
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  • 2.  RE: ISO 9001 Question

    Posted 17-Jun-2014 09:04
    Although medical device companies would benefit from some aspects of ISO 9001, in fact the international standard they are generally expected to follow in some jurisdictions (not USA) is ISO 13485, which is (at the moment) structured similarly, but which adds a number of items critical for a medical device quality system and omits the requirements for customer satisfaction and continual improvement.  However, the next revision of 13485 and the next revision of 9001 will be structured quite differently from each other(a whole separate story), despite maintaining essentially the same distinctions I just mentioned.
    That said, if you ask an FDA person, that person will tell you that the FDA does not concern itself with requirements in international standards (except for working to assure harmonization worldwide as much as possible consistent with FDA requirements).  For FDA requirements, the best source is the FDA website.  In particular, you may find the CDRH Learn section helpful.
    There are many reputable Registrars/Notified Bodies.  BSI is certainly one of them.  You will want to watch what is currently happening in Europe, where there is an ongoing effort to review certifications for Notified Bodies and some have already been decertified.

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States
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    Original Message


  • 3.  RE: ISO 9001 Question

    Posted 18-Jun-2014 23:15
    Agree with William White. Like BSI but also check Emergo (a Texas company). They provide a lot of information on their website.
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    Annette Zinn RAC, JD
    Regulatory Consultant
    San Antonio TX
    United States
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    Original Message


  • 4.  RE: ISO 9001 Question

    Posted 19-Jun-2014 02:34
    BSI has some good documents on their website that provide points to consider when selecting a notified bocy (almost like a checklist)
    There are many NBs and many good ones

    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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    Original Message


  • 5.  RE: ISO 9001 Question

    Posted 19-Jun-2014 20:17
    If your website will just provide health information, similar to a website like WebMD, FDA will not require anything, because that would be outside of FDA's scope of regulation.  If your company makes medical products, and you are going to use your website to promote your medical products, that would be a different matter.

    If you want to get ISO certified, I think ISO 9001 is a reasonable option.  This is a general standard for quality management systems that almost any type of organization can follow.  Most medical device companies follow ISO 13485 instead, but that's because it's a standard specifically applicable to quality management systems for medical device manufacturing.  It wouldn't apply to a website or a provider of health information.

    I'm not clear on the reason for your interest in FDA requirements or certification, given the type of website you seem to be proposing.  Perhaps if you gave us a bit more information, we could provide better guidance.

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    Julie Omohundro RAC
    Durham NC
    United States
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    Original Message