We are an ISO 9001 shop and our product is required to have lot number/finished product traceability under an ANSI standard.

We have decided to make an entirely different product that does not fall under this ANSI standard.

If we keep the traceability inhouse--is it required that have some sort of traceability/markings on the product in case of recall etc? I think so, my superiors do not.

thanks in advance

pammy

Pammy,

If there is no statutory, regulatory, or customer requirement, then traceability is not required. However, you should maintain identification of the product.

Stijloor.

Well at this point we dont know if there is a customer requirement, because we havent sold any as of yet.

Identification will be on the packaging, however I dont know if the actual product is going to be marked.

I will definately check that out. Of course it will be tracked inhouse and identified with the necessary "travelers".

thanks!
pammy

Well at this point we dont know if there is a customer requirement, because we havent sold any as of yet.

Identification will be on the packaging, however I dont know if the actual product is going to be marked.

I will definately check that out. Of course it will be tracked inhouse and identified with the necessary "travelers".

thanks!
pammy

Pammy,

If you are ISO 9001:2000(8) registered, then you should be familiar with clause 7.2.1 c) and 7.3.2 b)... Go look. ;)

Stijloor.