Section 7.1 of ISO 13485 - Risk Management throughout Product Realization

certified1

Starting to get Involved
#1
Hello Everyone,
Section 7.1 of ISO 13485 states that "the organization shall establish documented requirements for risk management throughout product realization". Can anyone tell me how I can determine what risks exist?
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#3
To start: Look at function and how the function can fail (not the liklihood of the failure, just what failure can happen no matter how unlikely)

How is your product used? How can it be misused? How can it fail?
 

Marcelo

Inactive Registered Visitor
#5
Also, this requirements deals with the need of performing a process risk management - the idea is that your manufacturing and other processes must not create risks to your products.

Anyway, this requirement sis really not very clear at the moment (and thus there´s a lot of interpretations - a lot of wrong ones :), on this). One of the topics in the review of ISO 13485 is an expansion of this requirement to better define what is really meant.
 

certified1

Starting to get Involved
#7
Thanks for your suggestion. This link has already been forwarded to me by another forum visitor. It good to know that you all are on the same page!!
 
F

FredLaBosche

#8
ISO 14971 for Risk Management provides really good material, especially in the appendices. Just go through the question catalogue there, it will really help you to determine the risks.
 
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