ISO 13485 - Documented Requirements for Risk Management

C

Cellardoor

#1
Hi everyone,

I'm new here *waves*.:bigwave:

I had a question regarding ISO 13485:2012. In 7.1 it states that "The organization shall establish documented requirements for risk management throughout product realization. Records from risk management shall be maintained".

So, what exactly does that mean? Basically an organization should have a document that states how they carry out risk managements, or? Has anyone in here written such a document and would like to share it with me? Or at least give me some advice about what such a document should/could include?

All the best and thanks in advance,
Cellardoor
 
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somashekar

Staff member
Super Moderator
#3
Hi everyone,

I'm new here *waves*.:bigwave:

I had a question regarding ISO 13485:2012. In 7.1 it states that "The organization shall establish documented requirements for risk management throughout product realization. Records from risk management shall be maintained".

So, what exactly does that mean? Basically an organization should have a document that states how they carry out risk managements, or? Has anyone in here written such a document and would like to share it with me? Or at least give me some advice about what such a document should/could include?

All the best and thanks in advance,
Cellardoor
Hii Cellardoor, Welcome here.
Please see through the "Similar Discussion Threads" just down this page.
 
C

Cellardoor

#4
Thank you -all of you- for your reply! However, I am still a bit confused. I am of course aware of the need for a risk management file as described in 14971, but from what I understand from ISO 13485 yet another document is required that establish how to perform the risk management process.

Am I wrong? I looked in the suggested links, but I don't think they made things totally clear for me.

All the best,
Cellardoor
 

sagai

Quite Involved in Discussions
#5
13485 contains all the general requirements for medical device manufacturers/entities to comply with in order to gain pre-assumption of conformity with some of the sections of the Canadian legislation and for EU legislation.
Other than that, it could be a contractual matter for supplier companies of the medical device manufacturer.

Therefore we could say 14971 addresses a subsection of 13485.
14971 elaborates how to address product risk related question in the medical device industry. It also provides pre assumption of conformities for major markets as regard to the corresponding subsection of the legislation itself.

It is in nutshell without overcomplicating the subject ...

Cheers!
 
K

ken butler 4321

#6
New here too. My interpretation of "Risk Management" is how you manage the risks to the actual product from its inception through its complete life cycle. It is not related to risk management as in personnel!!

It is the risk management of the product. ISO 14971 is a specific document to aid the process of the installation of a procedure for risk management.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Documented requirements does not necessarily mean a separate SOP or other document.

This clause means that the various SOPs covering product realization should include clear prompts for the various required risk management activities. Those activities could be covered in more detail in a stand-alone Risk Management SOP. ISO 14971 is a good reference to base such SOP upon.

There may be other risk management activities, in the product realization process, that do not come directly under the ISO14971 scope. In general, wherever big-impact decisions need to be made in uncertainty (either due to lack of information or lack of prescribed decision rules), or where compromise is the only economically viable option, a risk-based approach could come handy. A consistent documented process to handle such situations, rather than an intuitive "what-if" thinking, would be more likely to be acceptable by significant stakeholders. Again, such tools should be pointed to from specific points in the product realization process.
 
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