Customer Provide Control Procedure & Changes of Products and QMS Control Procedure

S

sayabodoh

#1
The notified body gave me a list on the SOP, among them, I have no idea about these two procedures:

(1) Customer Provide Control Procedure

(2) Changes of the products and QMS control procedure

Anyone has idea of this or there is relevant procedure with different name?
Thank you!
 
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C

Chance

#2
Re: Customer Provide Control Procedure/ Changes of the products and QMS control proce

The notified body gave me a list on the SOP, among them, I have no idea about these two procedures:

(1) Customer Provide Control Procedure

(2) Changes of the products and QMS control procedure

Anyone has idea of this or there is relevant procedure with different name?
Thank you!
Can you ask the notified body about what those two SOP's mean?
 

qusys

Trusted Information Resource
#3
Re: Customer Provide Control Procedure/ Changes of the products and QMS control proce

The notified body gave me a list on the SOP, among them, I have no idea about these two procedures:

(1) Customer Provide Control Procedure

(2) Changes of the products and QMS control procedure

Anyone has idea of this or there is relevant procedure with different name?
Thank you!
Which is the standard you are referring to ?
Did the registrar body request "documented" procedures?
Given that you did this question on medical standards device, I assume that you referred to ISO 13484 and14969, but I do not think the standards have these procedures as mandatory.
Please, could you give more details?:bigwave:
 
S

sayabodoh

#4
Re: Customer Provide Control Procedure/ Changes of the products and QMS control proce

I am running on a tight deadline and still waiting the notified body's response.
Yes, I am referred to ISO13485 and MDD93/42.
I am guessing if Customer Provide Control Procedure referred to Control of customer-supplied product procedure.
How do you think?
 

qusys

Trusted Information Resource
#5
Re: Customer Provide Control Procedure/ Changes of the products and QMS control proce

I am running on a tight deadline and still waiting the notified body's response.
Yes, I am referred to ISO13485 and MDD93/42.
I am guessing if Customer Provide Control Procedure referred to Control of customer-supplied product procedure.
How do you think?
Why didn't you clarify the issue with the registrar body?
Was it a non conformity in a third part audit?
I do not know if it is mandatory a documented procedure according to the standard you mentioned, but if the absence of a procedure ( also not documented) can carry to an issue or provoke it, you shall have it in place to mitigate the risk.
I think other expert Covers will contribute.:bigwave:
 
C

Chance

#6
Re: Customer Provide Control Procedure & Changes of Products and QMS Control Procedur

If the notified body don't respond on time. Can you call them? It is hard for us here to help you figure out what exactly meant by those from your notifying body. I suggest to clarify this to them.
 
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