1 reply to this topic

[Luigirobert]

Hi,

Anyone can help to share your opinion or interpretation of how to comply the clause 8.5.2 of ISO 9001: 2015,regarding the "identification" of the product in the process (i.e. to final product)?.

 

I mean, all final product "has to be identified as a good product or accepted product by QA", according to this clause?.

 

And what could happen, if I decided define in my management system, that all final product will not be identified as a "accepted", and we only we will identified all "Non conformance" product. All final product that comes out from production can take it as good product, whenever is nothing wrong found on product.

An ISO 9001 auditor what could think about this definition, is a non compliance to the clause?.

 

best regards.

Robert.

 

 

 

[Evans X.]

Greetings Luigi,

 

This is a guideline from ISO 9001. How you implement it is up to you, as long as you can logically explain and prove to an auditor that your process works. So if you want you could write down in your documented procedure something like that all products are considered accepted if these 1/2/3/4 criteria are met during inspection and that only for non-conforming products is documentation triggered.

The important part for this though is to identify the criteria according to which the product is ok and how it works. Is it automatically through a machine (eg X-ray, product measurements, comparison to a preset model of the product and it discards the "wrong" ones etc) or someone is responsible for the inspection and finding of non-conformant products. This process needs to be clear for the auditor on how non-conforming products are identified. Write down a robust procedure and then you won't have to check out every conforming product on a document, consuming time and resources.

 

Regards!