Exception to 6.4 a) thru d) - Excluded from the Scope of my Quality System

#11
On page 2 (3.3) is the official definition of an advisory notice. As a contract manufacturer, I am assuming your supplier and your customer are the same. So, passing on an advisory notice from your supplier to your customer probably won't happen. I also doubt that you would be advising your customer on uses of the device, or device modifications, or disposal /destruction of the devices (once again, I am assuming they already have that stuff figured out). However, they may send you some sort of advisory notice in regards to the device. In that case you probably want to evaluate the notice, and keep it on file. But, without knowing more, I think you could be correct when you say that the best you can think of is related to shipped product (which is the 3rd bullet in 3.3).
 
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#12
As a contract manufacturer, I am assuming your supplier and your customer are the same. So, passing on an advisory notice from your supplier to your customer probably won't happen.
Not true. We do purchase the components used for manufacture from our own suppliers. Therefore, yes, it could be possible that our supplier might provide us with a component recall notification. Then we would inform our customer.

I'm assuming then that this notification falls into the "advisory notice" category?

I also doubt that you would be advising your customer on uses of the device, or device modifications, or disposal /destruction of the devices (once again, I am assuming they already have that stuff figured out).
Now that this is brought up, there maybe cases where this could happen. Several of the items being manufactured were also designed by us. (contract engineering.)

However, they may send you some sort of advisory notice in regards to the device. In that case you probably want to evaluate the notice, and keep it on file.
Another valid point. I was in the frame of mind of addressing only advisory notices going out of my facility, not ones coming into it.


:thanks: Thanks for your help on this, db. Sometimes it takes poking the problem with a stick a couple times to see what happens.
 
J

jkonholm

#13
Iso 13485:2003 Clause 1.2 Application
"If regulatory requirements permit exclusions of design and development controls (see 7.3), this can be used
as a justification for their exclusion from the quality management system. These regulations can provide
alternative arrangements that are to be addressed in the quality management system. It is the responsibility
of the organization to ensure that claims of conformity with this International Standard reflect exclusion of
design and development controls [see 4.2.2 a) and 7.3]."

"If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of the
medical device(s) for which the quality management system is applied, the organization does not need to
include such a requirement(s) in its quality management system [see 4.2.2 a)]."

"The processes required by this International Standard, which are applicable to the medical device(s), but
which are not performed by the organization, are the responsibility of the organization and are accounted for
in the organization’s quality management system [see 4.1 a)]."


so Permissible exclusions:
Product design and development (chapter 7.3)
Validation of processes for production and service provision (chapter 7.5.2)
Customer property (chapter 7.5.4)
Preservation of product (incl. delivery) (chapter 7.5.5)
Control of monitoring and measuring devices (chapter 7.6)
 
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