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Who needs ISO?

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Guest user Created:   Mar 15, 2021 Last commented:   Mar 16, 2021

Who needs ISO?

In Canada, we hold the licence for a viral transport medium.  We are going to hire a 3rd party contractor to actually manufacture the medical device.  Who needs ISO?  Us? The 3rd party contractor? Or both?

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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.

Expert
Kristina Zvonar Brkić Mar 16, 2021

This decision depends primarily on who is the holder of the product, whose name will be on the product as the manufacturer.

If you are a manufacturer (license), then the manufacturer is expected to have ISO 13485 implemented. According to ISO 13485, when the manufacturer (license holder) outsources any part of the production process, this part of the process is still the manufacturer's responsibility. This means that regardless of the fact that you have outsourced that part of the production, that production must also be carried out in accordance with the requirements of ISO 13485. It doesn't matter if they will be ISO 13485 certified, or if you will make all this documentation as part of your ISO 13485 quality system. It all depends on how you agree. There must be a Quality Agreement between you and that company in which all mutual responsibilities will be described. Be prepared that regardless of your mutual agreement and the fact whether they are certified or not, there is a possibility that during your audit by a certification body, the auditor requires that an audit be conducted in that outsourced company as well. 

For more information on this topic, please see the following article:

You can see how we designed a Quality agreement with the subcontractor in our ISO 13485:2016 Documentation toolkit:

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Mar 15, 2021

Mar 16, 2021