Guest user Created: Dec 20, 2021 Last commented: Dec 21, 2021

Clean room criteria for ISO 13485

I have a 20 x 30 glass walled clean room sitting in a create for some time now and have decided to erect it so we can finally start working at an ISO 13485 situation. I would like to know for now only clean room criteria for iso 1 (class A) and based on that, I would like to know costs to retain you or cost to provide a cert jhow to go about getting an inspection etc

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Kristina Zvonar Brkić Dec 21, 2021

Thank you for the question. There is a lot of things that need to be taken into consideration when wanting to get an ISO 13485:2016 certificate. For the documentation, you can use our Documentation toolkit which has all necessary and required documentation from the standard. Prices and what is contained in the toolkit at the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

More information on the ISO1 3485, you can find on the following links:

How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
Checklist of ISO 13485 implementation steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

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Dec 20, 2021

Dec 21, 2021

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