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ISO 13485 toolkit ref 11

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Guest user Created:   Jan 31, 2022 Last commented:   Jan 31, 2022

ISO 13485 toolkit ref 11

I wonder if you can give me some guidance on ISO 13485 toolkit ref 11 procedure for production and service provision. As we are a distributor the only part I seem able to answer on here is 3.3.7, because I can relate that to the batch and serial tracking once we have received the goods through to their delivery at customer. I know the QMS says various parts of 7.5 can be excluded. But I am not sure if need to fill in more in order to be complaint?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jan 31, 2022

If you are a distributor, then you need to understand that your "production" is basically service provision. SO everywhere in the documentation that says "production," you can put "service". 
Your point of view regarding 3.3.7 is OK. You cannot exclude this; you will just use the identification provided by the manufacturer. You need to have in your system the possibility to track to which customer went which LOT of medical devices.   

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Jan 31, 2022

Jan 31, 2022

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