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ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt?

Jkc3usc12

Involved In Discussions
#1
Exempt from these 3 ISO 13485 clauses?

7.5.2 - My company is a distributer of a non-sterile product and have no required cleaning instructions besides a recommendation for the user.

6.4.2 - Returned product is received but any product that has been returned from the hospital is decontaminated there. The product distributed becoming contaminated has not happened.

7.5.6 - we do not design or manufacture any product.
 
Last edited by a moderator:

Rincewind

Involved In Discussions
#2
Hello,

7.5.2:
I do not believe you can exclude clause 7.5.2 from your QMS, it is stated:
"The organization shall document requirements for cleanliness of product or contamination control of
product if:
[...]
b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or
its use; [...]", this reads to me like it fits your product pretty well from what you told us.

6.4.2
I just had a pretty similar discussion with an auditor the other day, the question is, how do you make sure the device is properly disinfected/sterilized when it gets back to you? Do you have a form the hospital has to fill out and send you back with the product? The clause clearly states "potentially contaminated product" as well so depending on your auditor or a risk analysis performed by your people you might need a procedure for this as well.

7.5.6
This does not only apply to manufacturing processes but to service provision as well, so if you can not claim that all your processes are verifiable you might need to validate some, some companies get around this by performing final tests on every product they manufacture, as you do not manufacture anything I do not know if this can be used by you.
 

Jkc3usc12

Involved In Discussions
#3
Agree with your points. Again being solely a distributor of the product I just have a hard time with some of the elements. We receive it in a box, check it, then rebox, and send. That is the main function of the facility.

6.4.2 could I possibly say we do not receive contaminated product. If we do it is scrapped or not accepted?

7.5.6 again we do not manufacture so all validation and testing of product is done at before we receive it.
 

Rincewind

Involved In Discussions
#4
6.4.2 could I possibly say we do not receive contaminated product. If we do it is scrapped or not accepted?
If that is what happens then that would be your procedure. If the device is possibly contaminated it is scrapped. A simple procedure could maybe be: You only accept products which have some kind of certificate from the customer that it was decontaminated before it was send out to you (I have seen companies do that, for example companies selling surgical instruments), if this certificate is missing you scrap the product (or clean it yourself before further processing but that might be not possible for you if you are just a distributor.)

7.5.6 again we do not manufacture so all validation and testing of product is done at before we receive it.
Again, this clause does not only apply to the manufacturing process but service provision as well. It depends on what your part in the cycle of this product is, I am thinking about 7.5.4 servicing activities for example (as you mentioned you receive products back). But if you have concluded non of your processes need to be validated you could exempt it.
 

Lokus200

Starting to get Involved
#5
Agree with your points. Again being solely a distributor of the product I just have a hard time with some of the elements. We receive it in a box, check it, then rebox, and send. That is the main function of the facility.

6.4.2 could I possibly say we do not receive contaminated product. If we do it is scrapped or not accepted?

7.5.6 again we do not manufacture so all validation and testing of product is done at before we receive it.
6.4.2 - you can add receiving inspection requirements to verify that it was decontaminated.
7.5.6 - if your scope is distribution only, you should document the justification for it in your Quality Manual. You are not a manufacturer so you don't have to validate manufacturing processes, however, you may have to validate your distribution process.
 

Jkc3usc12

Involved In Discussions
#6
Hello,

7.5.2:
I do not believe you can exclude clause 7.5.2 from your QMS, it is stated:
"The organization shall document requirements for cleanliness of product or contamination control of
product if:
[...]
b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or
its use; [...]", this reads to me like it fits your product pretty well from what you told us.

6.4.2
I just had a pretty similar discussion with an auditor the other day, the question is, how do you make sure the device is properly disinfected/sterilized when it gets back to you? Do you have a form the hospital has to fill out and send you back with the product? The clause clearly states "potentially contaminated product" as well so depending on your auditor or a risk analysis performed by your people you might need a procedure for this as well.

7.5.6
This does not only apply to manufacturing processes but to service provision as well, so if you can not claim that all your processes are verifiable you might need to validate some, some companies get around this by performing final tests on every product they manufacture, as you do not manufacture anything I do not know if this can be used by you.
both 7.5.2 and 6.4.2 we did declare in our QM but was written a NC for not declaring the non applicable. This is what was written -
The Scope of the Quality Management System is not fully effectively described because not all non-applicable clauses have been declared
clauses 7.5.2 cleanliness, 7.5.6, validation of special processes, and 6.4.2 Contamination control, have not been declared.
 
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