I am up to facing an audit by Intertek for using the ETL mark on the products that we assemble. We do the assembly and test the products for USA OEM, per the procedures established by the OEM.
What can I expect this audit to be, like scope, functional areas that would be audited etc., Any guidelines, tips, suggestions from guys who have faced such an audit is much appreciated.
:thanx:

ITS will be looking for compliance with your listing report for that particular product. ITS will look at the processes to manufacture the product. The inspector will look at the labels on the product and compare these with the labels on the listing report. If the product has any PCB, it will be compared with the original one. Any deviations will be noted. If there are any engineering changes, it is better to inform ITS in advance.

Amjad Rana

It depends.

1) If company A applies ETL mark on the product, then company A must the manufacturer. However, if company B is supplier for company A, and does assembly without applying ETL mark before providing to company A, then both A and B will be listed as manufacturer.

2) According to what you mentioned, I guess your company does the medical device assembly and ETL mark label apply. So you will be the manufacturer. If so, you should make sure the products to be inspected must be the same as the critical components listed in the Intertek Report. The manufacturer should have Quality System to indicate how your company control the components quality during assembly. And the safety test, i.e. Hi-pot, grounding and leakage current should be tested and inspected by inspector.