Notified Body References and Reviews - Changing ISO 13485 Registrars

C

cardiac1

#1
We are planning from moving from our current NB, and I'm looking for some reccomendations and/or references. The two top contenders I am considering are LNE-GMED and BSI. We are ISO 13485, and have both Class IIB (Tech File) and Class III (Design Dossier) products. Our current NB only reviews the files in Germany, and all of our auditors are also brought in from Germany, and the cost and delays are no longer acceptable. LNE and BSI have both promised to perform all reviews in the US in a timely manner- within 3 to 4 months, and use US based auditors to reduce travel costs.

Does anyone else have any experience with LNE or BSI? Are they responsive to customer needs?
 
Elsmar Forum Sponsor
C

Crimson

#2
Re: Notified Body Reference

I have outstanding personal experience with KEMA - and know other manufacturers who do, too. They have a local US presence on both coasts - The new head of their Medical Device practice in the US (Dr. Jeff Schakenraad) approaches his role with a real sense of partnership - a very knowledgeable and helpful guy.
 
R

Roland Cooke

#3
We would be happy to compete for this business. (I'll have to let others on Elsmar sing our praises. :) )

Please feel free to speak with me, or any member of our Houston team, to discuss, 281-873-5800.
 
W

WisdomseekerSC

#6
We recently had our registration audits for AS9100 and ISO 13485 along with upgrade registration to ISO 9001:2008 (October 2009). We were recommended for all three :D.

The registrar was BVC (Bureau Veritas). We found the ISO 9001/AS9100 auditors very thorough but the ISO 13485 auditors (the only two they have in the US - one recently hired between our pre-assessment and registration audit) proved to be less so. No non-conformances were written and the observations were "trivial" IMHO. We had major problems with the quotes, schedulers and administration. Their recent leadership changes have not been satisfactory. We have communicated our experiences with the registrar.:(

We are now looking at our options. We need a registrar that is recognized internationally (with USA representation), reasonably priced, and has competent, professional, fair auditors with superior customer support services. In other words, we want to get our money's worth and receive valued-added service from our next registrar.

So who is hiring the "cream-of-the-crop" auditors these days who have actual experience in the medical device industry not just auditor training? Is there a Consumers Report for Registrars? :lol: Please share!
 

Doug Tropf

Quite Involved in Discussions
#7
Our first NB was TUV and we had issues with their generally trivial and often questionable audit findings. We have been with BSI for the past several years and have no complaints. The BSI auditors we've had are micro-biologists.
 
R

Roland Cooke

#8
Recruiting would-be auditors is an important part of my responsibilities at SGS (US), in conjunction with the NB head office over in the UK.

Our 'technical' CV template for each auditor is now pushing 20 pages, case-by-case justification for awarding each requested technical/clinical skillcode (of which there are hundreds). Hopefully that gives you an idea of how seriously we take this stuff.

In addition to assessing a candidate's technical background, we also obviously prefer to recruit people that have strong audit experience already. That's because although the theory is trainable, and we do of course conduct qualification audits for new auditors, the real mastery of auditing simply comes with time/experience, probably a couple of years full-time. Our clients are always understanding when we are bringing a new auditor up to speed.
Of course what is hardest to interview for at the recruitment stage are people-skills, which are a vital part of an auditor's skillbase.

Finally, you have touched upon two separate but very important aspects of dealing with a Notified Body. The performance of your audit team is critical, but just as important is the performance of the back office operations, both in terms of logistics planning and certification management, and also how much support you receive when you require it.


I'm biased of course, but I think SGS scores extremely highly on all these points.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
Is there a Consumers Report for Registrars?
Good question. No, unfortunately there isn't. Years ago Quality Digest had annual surveys on customer satisfaction with their respective CB's. There is a lot of information about those surveys and theories behind it's demise here at The Cove.

Fortunately or unfortunately, there is no single way to rank registrars. One of the reasons is the fact that the expectations and objectives of the registrar customers ranges dramatically. Some organizations hire registrars and expect thorough, fair, value added assessments, while others deliberately choose the ones known to be the path of least resistance to the certificate on the wall.

I still contend that, in addition to survey customer satisfaction within the registrar client base, one should also survey the actual users of the certificates, which are, for the most part, the registrant's customers. How much confidence they have on their suppliers certificates, because, in the end, confidence on certificates is a much more important indicator of the sustainability of accredited certification, not (CB) customer satisfaction.

I also offer participation in this Forum as a small indicator of the registrar's caliber. There are, relatively speaking, only a few CB representatives posting and (really) contributing to the discussions here. Why is that? After all, this is the PREMIER discussion site for management system professionals in the world. Why are so many CB's lurking in the dark side of The Cove scavenging for sales leads? Why are they so afraid of exchanging ideas here? Are they cowards? Don't they have anything to contribute in a positive manner? One should wonder...
 
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