ISO13485/9001 clause 6.3 (Infrastructure)

#1
Hi, we are a small company manufacturing IVDs (generally for veterinary/food safety) with no products requiring CE marking.

Looking at the ISO 13485/9001 clause 6.3 where it talks about maintenance of infrastructure, what exactly would constitute infrastructure required to achieve conformity to product requirements?

I mean, one could say that one needs a building, water and electricity. Internet access as well. Is it necessary to document maintenance requirements for the building, or the water supply?
 
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Sidney Vianna

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#2
Scroll down the page and you will see hyperlinked similar discussion threads, which will, very likely, answer your questions.
 

Ronen E

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#3
Hi, we are a small company manufacturing IVDs (generally for veterinary/food safety) with no products requiring CE marking.
ISO 13485 and ISO 9001 are two separate standards, quite different, especially in their latest issues (2016 and 2015 respectively). For this reply I’m going to assume that you actually apply ISO 13485:2016. If this standard is applicable to your products, they are Medical Devices. I don’t understand how that can be true and still your products won’t require CE marking (especially that you wrote “generally for...” and not “only for...”).

what exactly would constitute infrastructure required to achieve conformity to product requirements?
For simplicity, assume that any infrastructure is needed to achieve conformity to product requirements, unless you can document a clear rationale to the contrary. BTW, according to ISO 13485:2016 “Infrastructure” is more than what you noted, see items a-c under s. 6.3. Most significant is the inclusion of process equipment (item b).

Is it necessary to document maintenance requirements for the building, or the water supply?
S. 6.3 last paragraph says that maintenance requirements shall apply to “equipment”, so building and water supply are borderline in my opinion; however, one of the equipment types requiring documented meantenance requirements is such that is used in “control of the work environment”, so if you have, for instance, a cleanroom or a cooling system that utilises water, building and water supply might come under that clause.

Cheers,
Ronen.
 
#4
Thanks for the information. Our products are IVDs for food safety and veterinary. They do not need to be CE marked as they are not medical devices per se. That said, our customers still want to see ISO 13485 certification.
 
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