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Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing?

K

krism

#1
#1
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.
 
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somashekar

somashekar

Staff member
Super Moderator
#2
#2
krism said:
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.
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What is to be done is clearly said. Who has to do it is the arrangement of the company, that shall be planned and documented.
Whatever arrangements that one makes should be good and true covering all the regulatory requirements. The word "prospect" is more from the sales angle and not a regulatory consideration. The consideration is the User / Patient and Regulatory requirement
 
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