Company Names on Certificates

[tdeardorff]

Hello! I am hoping there will be someone here who has experienced a situation similar to the one my company is experiencing. For many years we have maintained ISO/MDD/CMDCAS certifications through the same NB. Our company has a legal entity name which is not present on any product labeling yet since it is the legal name, it has appeared on our certificates with various dba/trading names listed. With this year's recertification audit, the TF auditor has now indicated the dba names are not permitted and that our certificates themselves are not correct. This will cause large problems for our company which wishes to distribute products under the trade names known in the industry. I am thinking we cannot be the only company operating in this fashion. How has this been addressed in other situations? A larger problem is the fact that the certificates have been permitted (and reviewed) for years without any mention that the company names were not permitted. Thanks for any input to this matter as it will be greatly appreciated!

 

[Ronen E]

Hello! I am hoping there will be someone here who has experienced a situation similar to the one my company is experiencing. For many years we have maintained ISO/MDD/CMDCAS certifications through the same NB. Our company has a legal entity name which is not present on any product labeling yet since it is the legal name, it has appeared on our certificates with various dba/trading names listed. With this year's recertification audit, the TF auditor has now indicated the dba names are not permitted and that our certificates themselves are not correct. This will cause large problems for our company which wishes to distribute products under the trade names known in the industry. I am thinking we cannot be the only company operating in this fashion. How has this been addressed in other situations? A larger problem is the fact that the certificates have been permitted (and reviewed) for years without any mention that the company names were not permitted. Thanks for any input to this matter as it will be greatly appreciated!

Hi,

I would have asked that auditor to kindly show me the official clause which bans this practice.

Cheers,
Ronen.

 

[Sidney Vianna]

Check http://www.nbog.eu/resources/NBOG_BPG_2010_3.pdf

General Comment # 7

Certificates can only be issued to one manufacturer (natural or legal person). This does not allow the concept of ?doing business as? (dba) certificates, i.e. different ?names? of a manufacturer on one certificate.

Notified Bodies are extremely reticent in not following authorities advice, these days.

 

[tdeardorff]

Thank you for your replies. In the whole regulatory scheme, where do the NBOG documents fall? Are they an actual law/requirement or guidance for Notified Bodies? (the title is "Best Practice Guide") I don't want recommendations, I want the LAW about what we are required to do. It is increasingly impossible to keep up in this current regulatory environment with documents coming from nowhere. Just venting a bit...sorry.
Some of us in the QA/RA "trenches" need some strong guidance to all things regulatory as they apply to our specific product and company type? We firmly believe it is the NB responsibility to keep us informed of updates that we are required to know about however, they do not provide this service. For the money we have paid over the years, they should! Seems they would rather give us "gotchas" at audit time. Again, just venting.

 

[Ronen E]

Thank you for your replies. In the whole regulatory scheme, where do the NBOG documents fall? Are they an actual law/requirement or guidance for Notified Bodies? (the title is "Best Practice Guide") I don't want recommendations, I want the LAW about what we are required to do. It is increasingly impossible to keep up in this current regulatory environment with documents coming from nowhere. Just venting a bit...sorry.
Some of us in the QA/RA "trenches" need some strong guidance to all things regulatory as they apply to our specific product and company type? We firmly believe it is the NB responsibility to keep us informed of updates that we are required to know about however, they do not provide this service. For the money we have paid over the years, they should! Seems they would rather give us "gotchas" at audit time. Again, just venting.

I understand exactly what you mean, and can sympathize with your pain.

However, one very important thing to understand is the context. NBs are not public servants and not public elected. They are in essence commercial entities, businesses. All your interactions with them take place in a commercial landscape. If all (or most) NBs unite and align with NBOG, then it doesn't really matter if it's law or not (of course they still have some restrictions under the law and their notification, but generally that's how it is). Once they all agree on something as "best practice", that's pretty much it, unless you want to go fight it in court (good luck). Similarly, if you're not happy with the service your NB provides for what you pay them, you're legally free to change a NB. If no NB provides a better deal, that's just what the free market offers and you will have to accept it. I don't mean to be offensive in any way, just sharing my viewpoint which you are entitled to completely ignore

Cheers,
Ronen.