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View Full Version : Obsolete a DoC if NB (Notifying Body) changed


regqual
24th March 2009, 04:42 PM
We recently changed NB and I'm wondering if the previous DoC becomes obsolete now? Also, if I add a new product to the product line, should I revise the DoC or create a new one? They would be in the same Tech File as its a simiar product with small variations.

Thanks, all.

Coury Ferguson
25th March 2009, 12:54 PM
Can anybody help here?

mmagargee
25th March 2009, 04:27 PM
We manufacturer products for Zone 1 Hazardous locations and this requires (as a result of the ATEX directive) a third party certificate. Our NB required us to place their name and our certificate number on our DOC. If I moved NBs, then the information would change and the DOC would have to be updated.

You would also have to update your DOC when the standard revision changed to show that your product was in compliance with the latest standards.

Roland Cooke
25th March 2009, 08:02 PM
We recently changed NB and I'm wondering if the previous DoC becomes obsolete now? Also, if I add a new product to the product line, should I revise the DoC or create a new one? They would be in the same Tech File as its a simiar product with small variations.

Thanks, all.


Think of the DoC like a batch record. All products made under the original NB's EC certificate are covered by the first DoC. A second DoC is created for products manufactured from the date of issue of the new NB's EC certificate.
Like a batch record, the first DoC is not obsoleted, it's now a record to be formally archived.

There should be no gap in certification. If there is, you need to resolve what happens with any product manufactured in the limbo period.