List of Sales Procedures required for ISO 13485

E

eileenr

#1
Hello,
Is there a comprehensive list of all procedures which can be included in an ISO 13485 QMS, the scope has changed to include sale of the medical device and I just need to know what procedures I need to include. Thank you:)
 
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Marcelo

Inactive Registered Visitor
#2
ISO 13485 does not require a sales procedure directly, so any procedure you might include in the system are the ones you define as required for the sales "process" to achieve it?s objective.
 
Last edited:
E

eileenr

#3
Hi Marcelo,
Thank you for your prompt reply. I ought to have mentioned that I am developing the QMS and at present I am trying to get the business so I am currently trying to create a project plan, its a bit abstract at the moment so I was trying to get a time line based on the sales procedures I would need to write but currently I do not know what they are. Thanks so much for answering me though.
:bigwave:
 

Marcelo

Inactive Registered Visitor
#4
In this case, you might perform a quick process mapping using tools suach as a turtle diagram to have a genral overview of those process (obviously you woould need to perform a complete process mapping afterwards during the full quality system planning process).
 
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