Risk Management Procedure Mandatory in ISO 13485

T

Tiffany

#1
Hi mates,

In order to comply with ISO13485, we shall develop the risk management for our medical devices. Our risk management file has cover the overall contents in conducting risk management and the result + report of the risk management conducted.

Is necessary or mandatory to have a documented procedure for risk management? (As all the steps and procedure have written in our existing risk management file). If so, what should be the contents of this risk management procedure?

This issue have been raised by our third party auditor and we explain that is written in the Risk Management File, but he don't accept!


:thanks:
Tiff
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Risk management procedure is Mandatory??

Hi mates,

In order to comply with ISO13485, we shall develop the risk management for our medical devices. Our risk management file has cover the overall contents in conducting risk management and the result + report of the risk management conducted.

Is necessary or mandatory to have a documented procedure for risk management? (As all the steps and procedure have written in our existing risk management file). If so, what should be the contents of this risk management procedure?

This issue have been raised by our third party auditor and we explain that is written in the Risk Management File, but he don't accept!


:thanks:
Tiff
Tiff,

I am not an expert in ISO13485, but here is my opinion:

If Risk Management is a critical part of the way the Business operates, than I feel documenting that process would be worth while.

Take into consideration that if, something happens to the Organization's Leadership, the person(s) taking the role would need to know, how the risk management was done.

This is just my opinion, and I am not an expert in the ISO13485 standard.
 

GStough

Staff member
Super Moderator
#3
Re: Risk management procedure is Mandatory?? (ISO 13485)

Hi mates,

In order to comply with ISO13485, we shall develop the risk management for our medical devices. Our risk management file has cover the overall contents in conducting risk management and the result + report of the risk management conducted.

Is necessary or mandatory to have a documented procedure for risk management? (As all the steps and procedure have written in our existing risk management file). If so, what should be the contents of this risk management procedure?

This issue have been raised by our third party auditor and we explain that is written in the Risk Management File, but he don't accept!


:thanks:
Tiff
Hi Tiff,

ISO 13485:2003 states in 7.1 "The organization shall establish documented requirements for risk management thoughout product realization. Records arising from risk management shall be maintained." Those requirements may be in the form of procedures, but they don't necesssarily have to be. We have a procedure for risk management because it is an important part of our processes.

I hope this helps.
 
M

MIREGMGR

#4
Re: Risk management procedure is Mandatory?? (ISO 13485)

How do you conduct risk analyses now...informally according to an individual's perception of what to do, or per ISO 14971, or some other way?

If you need to formalize risk management, basing your process on ISO 14971 may be advisable.
 
T

Tiffany

#5
Re: Risk management procedure is Mandatory?? (ISO 13485)

The development of our Risk Management File is based on the ISO 14971:2007.

In our Risk Managment file consists of the responsibilities , risk management team, risk mgmt plan , risk analysis, risk assessment, risk estimation scheme, and risk acceptble criteria, risk control, risk evaluation, others unforeseen risk, intended USe/ Intended Purposes and Identification of Characterisitics related to the safety of the Medical Devices, risk Identification and Hazard Evaluation and risk Management Report etc....

The entire file basically base on the risk management process as per Figure 1 in the ISO 14971:2007.

Should we still necessary to have Risk Management Procedure??

Tiff
 
R

Roland Cooke

#6
Re: Risk management procedure is Mandatory?? (ISO 13485)

I'm finding that when I advise people to differentiate between

1) risk management relating to design control
2) risk management relating to the other sections of Clause 7

a lightbulb often goes off. :D
 
S

SteveK

#7
Re: Risk management procedure is Mandatory?? (ISO 13485)

For my Technical Files for Medical Devices, in a Risk Management Section I have a check list based on a template rather than a procedure; much like you can use for ISO 13485/9001 auditing purposes i.e. clause by clause checks. So in a table format on the left column the clause requirement/reference and on the right, ”Documentation of Compliance” evidence e.g. in 3.1 and 9, could include ‘Complaints Analysis’. Clause 4.3 section lists the identified hazards (known ones can include examples of ‘Device Alerts’, FDA warning letters for equivalent devices etc). After using one of the risk matrices as indicated in ISO 14971, I have separate sheets to expand the hazards and risk elimination/reduction actions. If a new risk is identified, the document is updated by issue number, change control etc.

Steve
:)
 
C

cutcoag

#8
Re: Risk management procedure is Mandatory?? (ISO 13485)

Hi. Can some please send me an approved ISO 14971:2007 Risk Management procedure and forms. I just completed them in the last few days and saved them on my C: drive instead of the server like a dope. My computer is on the blink and I can't get to them and I need them right away. Can anyone help? I'm really in a bind!!!!!!!!!!!!!!! Help!!!!!! Damsel in distress!!!!!!!!!!!!!!!!
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Re: Risk management procedure is Mandatory?? (ISO 13485)

The development of our Risk Management File is based on the ISO 14971:2007.

In our Risk Managment file consists of the responsibilities , risk management team, risk mgmt plan , risk analysis, risk assessment, risk estimation scheme, and risk acceptble criteria, risk control, risk evaluation, others unforeseen risk, intended USe/ Intended Purposes and Identification of Characterisitics related to the safety of the Medical Devices, risk Identification and Hazard Evaluation and risk Management Report etc....

The entire file basically base on the risk management process as per Figure 1 in the ISO 14971:2007.

Should we still necessary to have Risk Management Procedure??

Tiff
Hi,

Having a risk management file / process is very good, but when do you activate it? When do you update the contents? Etc.

The meaning of the requirement in ISO 13485:2003 clause 7.1, as I see it, is that your other product-realization-related procedures should include pointers specifying when and how this process is trigerred.

Cheers,
Ronen.

PS No, I don't think a stand-alone risk management procedure is mandated by ISO 13485:2003.
 
W

Wicham

#10
Re: Risk management procedure is Mandatory?? (ISO 13485)

Hi. Can some please send me an approved ISO 14971:2007 Risk Management procedure and forms. I just completed them in the last few days and saved them on my C: drive instead of the server like a dope. My computer is on the blink and I can't get to them and I need them right away. Can anyone help? I'm really in a bind!!!!!!!!!!!!!!! Help!!!!!! Damsel in distress!!!!!!!!!!!!!!!!
I have a form for Risk management in German language. Is this usefull for you?
Best regards Wicham
 
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