Should a company create different SOPs for ISO14971?

J

JeanG

#1
Hi, All
I am very new to ISO14971, i am currently creating a risk management manual, i wonder do we need all detailed procedures like QMS, such as risk plan SOP, risk analysis procedures, risk control procedures, and risk management report procedures? are these all necessary? How do audit check the ISO14971?

Many thanks for your help here.
 
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yodon

Leader
Super Moderator
#2
Re: Should company create different SOPs for ISO14971?

ISO 14971 provides the framework for risk management. You do need to document how you implement that framework at your company. The classic example is the risk matrix: will you do a 5x5 matrix, what values do you assign, and where are the thresholds.

The depth to which you take your internal procedures is up to you. Mostly, I've seen procedures that don't get into too much detail but provide sufficient structure for how the company implements 14971. Generally, it's a single SOP.

Regarding the auditing question, BSI (no affiliation) recently gave a webinar on what they're directing their auditors to look at regarding the (somewhat recent) harmonized EN 14971. It's available for free, on-demand (https://bsi.learncentral.com/shop/C...71:+2012+Risk+Management+and+MDD+Requirements) (again, no affiliation and not an endorsement). That might give you a little insight as to what an auditor might want to see - but focused only on the deviations as a result of harmonization.
 
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