Auditing Sales and Marketing Processes and Technical Support

SpartanBio

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#1
I am planning on auditing our Sales and Marketing processes and Technical support. For technical support i need to look at installation and servicing I think and the Sales and marketing is giving me issues. I am not sure against what I should be auditing. Our internal documents I suppose but odes ISO or Health Canada specifically offer any guidance in this area.

Thanks for any help you can provide me.
 
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isoalchemist

#2
I'm not aware of any specific guidance that exist.

My take has always been that Sales and Marketing is really labeling. Does anything exist in this documentation that is not in agreement with intended use of the product. Are you selling product you do not have approvals on? Are you making claims that cannot be supported " ISO FDA or HC" "Approved "where they mean listed. For ISO are you using your Registrars trademarks correctly and not inferring product approval by them (they approve your system). Certainly your own procedure and the control of the Sales and Marketing slick etc.
 
#3
I am planning on auditing our Sales and Marketing processes and Technical support. For technical support i need to look at installation and servicing I think and the Sales and marketing is giving me issues. I am not sure against what I should be auditing. Our internal documents I suppose but odes ISO or Health Canada specifically offer any guidance in this area.

Thanks for any help you can provide me.
Are you being assigned this audit by someone else? If so, and you don't know what you're auditing, you should go back to them and say so! If this is your own assignment, study your own documents. You may have to learn "on the fly" about what they do and any impact on CMDCAS requirements. (You can check ISO 13485 too). Your main focus should be on your own process, however.
 
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