W
wrustywrench
Would someone put this in simple terms ,please
thanks,,,
thanks,,,
CarolX
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Re: Iso 13485 Risk Management
I wrustywrench,
If you are looking for general info and discussion on ISO 13485, you can scroll down to the bottom of this page for links to similar threads. You will probaly find more info on the ISO 13485 boards.
I wrustywrench,
If you are looking for general info and discussion on ISO 13485, you can scroll down to the bottom of this page for links to similar threads. You will probaly find more info on the ISO 13485 boards.
Re: ISO 13485 Risk Management
In simple terms:
Regulatory requirements requires that the risk of a medical device be acceptable during the life cycle of the device. Risk management is a process in which you manage the risks (and keep it acceptable) during the product life cycle. See ISO 14971 for the best example of how to implement a risk management process.
ISO 13485 asks for risk management because it is accepted that the risks must be managed.
Cheers
In simple terms:
Regulatory requirements requires that the risk of a medical device be acceptable during the life cycle of the device. Risk management is a process in which you manage the risks (and keep it acceptable) during the product life cycle. See ISO 14971 for the best example of how to implement a risk management process.
ISO 13485 asks for risk management because it is accepted that the risks must be managed.
Cheers
Q
QA-Man
For more check out this thread:
https://elsmar.com/Forums/showthread.php?t=21190
The core idea behond Risk Analysis & Management is:
At each stage of product development (from concept to post-market) you must say "what are the risks", "are there any dangers", "what can go wrong", and "how can someone make a mistake.
If you find a potentional hazard you must say, in the following order, "can we reduce this by changing the design (round instead of sharp edges)", "can we reduce this by some protective measure in the device or manufacture of the device (like an alarm in the device)", and "can we reduce this with information (warning label or good instructions for use)"
Finally, you must document when you asked yourself these questions, what the answers were .
There are many ways you can do this but the way you document should be suited to your organization's needs and resources.
https://elsmar.com/Forums/showthread.php?t=21190
The core idea behond Risk Analysis & Management is:
At each stage of product development (from concept to post-market) you must say "what are the risks", "are there any dangers", "what can go wrong", and "how can someone make a mistake.
If you find a potentional hazard you must say, in the following order, "can we reduce this by changing the design (round instead of sharp edges)", "can we reduce this by some protective measure in the device or manufacture of the device (like an alarm in the device)", and "can we reduce this with information (warning label or good instructions for use)"
Finally, you must document when you asked yourself these questions, what the answers were .
There are many ways you can do this but the way you document should be suited to your organization's needs and resources.
W
WilBryan
Hoping someone might be able to help me out... I have been recently 'promoted' to QMS coordinator for our company. We are ISO 9001:2008 and 13485:2003 certified (13485 was completed in January 12').
The company does not build medical devices, we do low to medium volume contract manufacturing and design and build jobs of a complex electro-mechanical nature. One example would be a machine which converts non-wovens into surgical dressings and packages them. In other words, we do not make any medical devices, we make the machines that make medical devices.
So, we are now delving into our risk management program and trying to figure out how to meet requirements that are clearly spelled out but do not apply to our business model.
When maintaining a risk management program to meet 13485 standards is it mandatory that your process also meet 14971 standards?
Can we take an additional exclusion specific to medical devices?
I know this is a little confusing but as I said, Ive been dropped into this, am new to the QMS world and am still learning how to ask decent questions.
any and all help will be greatly appreciated.
Thanks!
w.
The company does not build medical devices, we do low to medium volume contract manufacturing and design and build jobs of a complex electro-mechanical nature. One example would be a machine which converts non-wovens into surgical dressings and packages them. In other words, we do not make any medical devices, we make the machines that make medical devices.
So, we are now delving into our risk management program and trying to figure out how to meet requirements that are clearly spelled out but do not apply to our business model.
When maintaining a risk management program to meet 13485 standards is it mandatory that your process also meet 14971 standards?
Can we take an additional exclusion specific to medical devices?
I know this is a little confusing but as I said, Ive been dropped into this, am new to the QMS world and am still learning how to ask decent questions.
any and all help will be greatly appreciated.
Thanks!
w.
T
treesei
I am just curious: Why does a non-medical device maker company get itself certified to ISO 13485? While many device component suppliers try to stay away from costly 13485, why does an equipment maker get into it?
Last edited by a moderator:
Welcome to the QMS world!
Exclude them?...
Not necessarily, though it's a preferred way to comply.
Cheers,
Ronen.
Exclude them?...
Not necessarily, though it's a preferred way to comply.
Cheers,
Ronen.
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