ISO 13485 and OBL (Own Brand Label) Agreement

L

Luisiso

#11
Ok, it makes more sense now what you are saying. We need to include the manufacturer part because we need to appear as the "manufacturer" in the certificate. I also read online that the audits on the OEM can be waived by notified of body.. What do you think?
 
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somashekar

Staff member
Super Moderator
#12
Ok, it makes more sense now what you are saying. We need to include the manufacturer part because we need to appear as the "manufacturer" in the certificate. I also read online that the audits on the OEM can be waived by notified of body.. What do you think?
It could be waived. Hope it is in your case. But covering it in the OBL agreement is prudent.
 
L

Luisiso

#13
Ronen,
Today, the OEM told me that there is a fastest way for us to achieve ISO and it is less complex and it is applying as a ODM. Original Design Manufacturer. Do you know anything about it?
 
L

Luisiso

#14
Ronen,
After reading some information online, it seems to me that every NB will requiere different things. For example, some of them waive the audit to the OEM. Some others requires only a technical file so does this means it would be better for me to look for a NB that do not requires too much from my business?. For example, if the audit on OEM are waived it means we will save money by no having the OEM audited. Others people recommend me to use the same OEM NB since they have their information on file but this NB has told us they will audit the OEM. So at this point not sure what to do..
 
M

MIREGMGR

#15
I suggest: never ever choose a certification body on the basis that they don't have many requirements, don't audit you very deeply, and/or are cheap.

Instead you should strongly consider using a certification body that your most important customers tell you is the one they trust the most.

Original Design Manufacturer
I've never heard of this, so I'm curious too.
 

Ronen E

Problem Solver
Staff member
Moderator
#16
We need to include the manufacturer part because we need to appear as the "manufacturer" in the certificate.
This is just a terminology. "Manufacturer" on the certificate relates to your regulatory status. You could be the regulatory manufacturer without doing any actual manufacturing, and it says quite little about your specific regulatory obligations.

Today, the OEM told me that there is a fastest way for us to achieve ISO and it is less complex and it is applying as a ODM. Original Design Manufacturer. Do you know anything about it?
No, I don't. Perhaps your OEM was referring to what we are already discussing. It sounds like your OEM is referring not only to ISO 13485 certification, but to EC clearance (CE marking). There is no "faster", "less complex" way to get ISO 13485 certification than to scpoe and apply a QMS that is in alignment with what the organization actually does (which excludes manufacturing in your case).

After reading some information online, it seems to me that every NB will requiere different things. For example, some of them waive the audit to the OEM. Some others requires only a technical file so does this means it would be better for me to look for a NB that do not requires too much from my business?. For example, if the audit on OEM are waived it means we will save money by no having the OEM audited. Others people recommend me to use the same OEM NB since they have their information on file but this NB has told us they will audit the OEM. So at this point not sure what to do.
I apologize upfront if what I'm about to write will sound like self promotion. This is not my intention. I don't even know where your organization is located so there's a good chance that I'm not relevant to you (I believe that the best is to have the consultant come on site at least once or twice for a QMS implementation).

You sound confused and lacking necessary understanding of how the relevant regulatory systems work, what the various elements mean etc. Reading online can be a great way to learn, but let me warn you that to get a good understanding this way you will have to spend many days (as in weeks and months) reading. Plus, your potential OEM is not the best source for regulatory advice. Remember, they are a stakeholder and their interests might not coincide with yours. I think you really need a good consultant by your side - someone whom you trust, because there will be situations where that person will tell you "this is in your best interest" and it will be, even though it will seem to you that there is "a better way". In regulatory affairs, sometimes the "longer" and "more expensive" way turns out to actually be the quicker and cheaper.

Specifically, it's important you understand that what you refer to as "ISO" is actually more than just ISO 13485 certification. For ISO 13485 certification you don't necessarily need a NB - any ISO 13485 certifying body (CB) would do. Mentioning a NB tells me that you're actually after an EC certificate, which is required for CE marking of devices in classes higher than plain class I. Until now you have asked about ISO 13485 certification, and my answers to you were in that context. EC certification involves additional nuances.

it's true that different NBs require different things, but I believe that in this case it looks "different" to you simply because you lack the background to understand what they are talking about. There is an OBL track for CE marking, based on an existing clearance held by the "real" manufacturer (the OEM). This track is normally quicker and easier, however it only works if the OBL hires the same NB as the OEM. In that arrangement, the OEM is being on-site audited by the NB anyway, to get their own EC certification, regardless of the OBL; so there's no need for additional auditing just because they contracted with the OBL. Whether the OBL certification involves on-site audit of the OBL is up to the NB, but I think most of them are likely to audit at some level.

I don't think it would make practical sense for you to try and become a regulatory specialist for this. Instead, I recommend that you find someone knowledgeable that you really trust (and is really committed to walking you through) and follow their advice, rather than collecting bits and pieces from various sources. I apologize if it comes across as offensive, it's not my intention and I really believe this is in your best interest.

Good luck,
Ronen.
 
L

Luisiso

#17
Can some one recommend me a good reputable Notified of body that has experience working with OBL?. For example, one that understand OBL situation, accept the OEM (real manufacturer) certification and possibly waive audition for the OEM? The current NB we are working on has not clue what is a OBl.. They want me to proof that we have 100% control over manufacturing and comply with every single procedure like we were the real manufacturer. I heard that OBl can cause confusion but not for a NB that has years of experience so I do not understand all the mixed information we are getting from them.


Secondly. can you recommend a Consultant with experience on OBL business pursuing ISO and CE ? The one I hired has not clue.. He does not even know that an agreement should exist between OBL and OEM.
 

Ronen E

Problem Solver
Staff member
Moderator
#18
Can some one recommend me a good reputable Notified of body that has experience working with OBL?. For example, one that understand OBL situation, accept the OEM (real manufacturer) certification and possibly waive audition for the OEM? The current NB we are working on has not clue what is a OBl.. They want me to proof that we have 100% control over manufacturing and comply with every single procedure like we were the real manufacturer. I heard that OBl can cause confusion but not for a NB that has years of experience so I do not understand all the mixed information we are getting from them.


Secondly. can you recommend a Consultant with experience on OBL business pursuing ISO and CE ? The one I hired has not clue.. He does not even know that an agreement should exist between OBL and OEM.
Hi,

To benefit the OBL/OEM concession path you should be engaging with the same NB as your OEM. I recommend you approach that NB and request a quote for your own EC certificate under an OBL arrangement. Refer here for details.

I'd be glad to assist you in the process, as a consultant. If you'd be willing to share your geographical location (either here or in your user profile, or in a private message) then we could tell whether that is a viable option, and if it's not perhaps I or others could refer you to someone closer.

Cheers,
Ronen.
 
Last edited:

DannyK

Trusted Information Resource
#19
Can some one recommend me a good reputable Notified of body that has experience working with OBL?. For example, one that understand OBL situation, accept the OEM (real manufacturer) certification and possibly waive audition for the OEM? The current NB we are working on has not clue what is a OBl.. They want me to proof that we have 100% control over manufacturing and comply with every single procedure like we were the real manufacturer. I heard that OBl can cause confusion but not for a NB that has years of experience so I do not understand all the mixed information we are getting from them.


Secondly. can you recommend a Consultant with experience on OBL business pursuing ISO and CE ? The one I hired has not clue.. He does not even know that an agreement should exist between OBL and OEM.
I am going through the process of getting a company an OBL. The problem that exists right now is that the requirements and interpretations are changing. It used to be that there was no requirement for an on-site audit and now there is. There is also a new requirement that the technical file has to be in STED format. Requirements may also differ between different countries.

I am a CE medical device assessor and I have the experience and information that most consultants do not have since I am being trained by the notified body about the OBL requirements.

Please send me a private message if you would like any further information.

Good luck and happy holidays!
 
L

Luisiso

#20
I really appreciate your feedback. The reason I said that different NB requires different thing is because I have read that on this forum. For example, some of them will waive the audition of the OEM and accept OEM certification and others do not. so this tell me that every NB has different requirements..
 
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