How to Document Risk Effects on Design Change(s)

#1
Hi everybody!

I was wondering if someone can help me and explain how to document change happen on initial device requirement after risk assessment over requirements?
 
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B

BhupinderSinghPawa

#2
Typically the Product Requirements and Risk Management File are documents/records under documentation control. A new requirement added can lead to risk analysis and similarly risk analysis determining a new risk control measure can lead to a new product requirement. Handle this with document change control to both the documents - typically in revision history capture the reason for change and the changes done. Some organizations may have a DCO (document change order) process in place and DCO # can be referenced for traceability.
 

qualprod

Trusted Information Resource
#3
Hoy may have two control sn
One for the design change and other for the risk .
Now with 2015, it is recommended to have a risk register, on it, you can use it for tracking risks.
Hope this helps oí
 

Marcelo

Inactive Registered Visitor
#4
Hoy may have two control sn
One for the design change and other for the risk .
Now with 2015, it is recommended to have a risk register, on it, you can use it for tracking risks.
Hope this helps oí
I think you are confusing the comment, which was made in the ISO 14971 forum and links with ISO 13485, with ISO 9001.
 
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