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Does 13485:2016 - 7.2.3 Customer Communication include marketing?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Qualityforum Mainar, Nov 10, 2017.


Should the marketing process be part of a 13485:2016 QMS?

Poll closed Dec 10, 2017.
  1. Yes

    0 vote(s)
  2. No

  1. Qualityforum Mainar

    Qualityforum Mainar New Member

    Feb 6, 2017
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    13485:2016 7.2.3 states that the organization shall plan and document arrangements for communicating with customers in relation to product information.

    Can anyone refer me to a source that states that this clause was intended by the standard writers to include marketing into a QMS? I have read about this in another forum that stated that marketing is for "prospects" and not actual customers. I, however, disagree in which marketing can reach and also specifically target current customers.
  2. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    Not sure you can make general assumptions about the responsibilities of marketing. Some may well be responsible for customer communications whereas others may not.

    Marketing outputs may very well be considered labeling so that may be another avenue for possible inclusion.
    Atul Khandekar likes this.