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Does nonconforming product include reagents/disposables?

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Mandy

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#1
#1
Does the nonconforming product mentioned in Section 8.3 of ISO 13485 relate to reagents and disposables, or only to the company's manufactured product?
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Sidney Vianna

Sidney Vianna

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#2
#2
In part, it does. But they are more appropriately handled in 7.4.3 of ISO 13485:2016.

Personally, I think the new definition of "product" in ISO 13485:2016 and ISO 9000:2015 is a botched definition. Previous one was much better.
 
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