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ISO 13485:2016 - Processes exempt from process validation

#1
ISO 13485:2016 defines criteria for processes which need to be validated. I want to ask that the processes which do not need to be validated, is there any requirement for equipment qualification for those processes, or IQ, OQ, PQ requirements? If yes, how to go about it as complete validation is not required.

Thanks in advance
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
In principle, processes don't require validation where the output is verified 100%. In such cases there is no concern about the process because it's effectiveness is checked directly on the output (the product). IMO, from a 13485 compliance perspective you should be fine in such cases with any extent and manner of qualification you choose to implement. Make sure, however, that you are still in compliance your own SOPs requirement-set.
 

Marcelo

Inactive Registered Visitor
#3
I always think that there's some misconceptions when we talk about process validation.

First, we need to separate between before a process is put into service/operating - A (which related to the process planning) and after the process is put into service/operating - B.

Process validation requirements are application to B, not A - special processes are processes where I cannot verify that the output of the process, when the process is operating that, and thus I cannot guarantee conformity (please note that ISO 13485:2016 also includes the situation where you do not WANT to verify the output, thus transforming the process into a special processes.

In relation to A, any process needs verification. So, when you plan the process, you define process requirements, and, before putting the process into service/operating, you need to verify that it can proceed the expected results. In this way, you are verifying that the process can be put into service/operating.
 
#4
I always think that there's some misconceptions when we talk about process validation.

First, we need to separate between before a process is put into service/operating - A (which related to the process planning) and after the process is put into service/operating - B.

Process validation requirements are application to B, not A - special processes are processes where I cannot verify that the output of the process, when the process is operating that, and thus I cannot guarantee conformity (please note that ISO 13485:2016 also includes the situation where you do not WANT to verify the output, thus transforming the process into a special processes.

In relation to A, any process needs verification. So, when you plan the process, you define process requirements, and, before putting the process into service/operating, you need to verify that it can proceed the expected results. In this way, you are verifying that the process can be put into service/operating.
I have a confusion about equipment qualification, which is a part of process validation. For process which does not need validation, is there a need for equipment qualification of equipment used in that process? If yes, please give some detail or reference document as to what extent equipment qualification would be sufficient?
 

somashekar

Staff member
Super Moderator
#5
I have a confusion about equipment qualification, which is a part of process validation. For process which does not need validation, is there a need for equipment qualification of equipment used in that process? If yes, please give some detail or reference document as to what extent equipment qualification would be sufficient?
Equipment qualification aka IQ.
I understand that your process does not need validation, however there is an equipment.
The check for having provided all of the proper connections (inputs) to the equipment as suggested, including its proper fixing / suspending etc etc per recommendation.
The check of the satisfactory operation of the equipment. All indicators, meters operating satisfactorily, no abnormal vibrations / noise... (No error code / error signal visible or alarm heard)
The check of the desired output when operational, when you feed the correct inputs (materials)., including operation of any emergency stops etc.
All these done by qualified personnel and made as a form of a report .....
becomes your equipment qualification.
I hope such an exercise will give you enough confidence that the equipment is qualified for your intended use.
 
Last edited:
#6
Equipment qualification aka IQ.
I understand that your process does not need validation, however there is an equipment.
The check for having provided all of the proper inputs to the equipment as suggested, including its proper fixing / suspending etc etc per recommendation.
The check of the satisfactory operation of the equipment. (No error code / error signal visible or alarm heard)
The check of the desired output when operational, including operation of any emergency stops etc.
All these done by qualified personnel and made as a form of a report .....
becomes your equipment qualification.
I hope such an exercise will give you enough confidence that the equipment is qualified for your intended use.
Yes that's what I was looking for.
Another question. I could not find a requirement for equipment qualification in ISO 13485, so it seems to be optional......?
 

somashekar

Staff member
Super Moderator
#7
Yes that's what I was looking for.
Another question. I could not find a requirement for equipment qualification in ISO 13485, so it seems to be optional......?
You please see how the equipment qualification fits into the ISO 13485:2016 clause 6.3 and in that the 6.3 b)
 
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