Experience working with TUV SUD or Rheinland, and/or BSI

#1
Looking to share any current issues that your company may be experiencing.
delay with replies or certificates being issued?
Non-responsive? delayed audits?
Please share your experiences. Positive feedback also welcomed.
 
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Randy

Super Moderator
#2
I know it's been an on again/off again problem with one of them for a bit and it might be how you're communicating and to whom.

What standards are you referring to because that can be part of the problem?

You can do a PM if you want.
 
#3
I know it's been an on again/off again problem with one of them for a bit and it might be how you're communicating and to whom.

What standards are you referring to because that can be part of the problem?

You can do a PM if you want.
PM is not working right now. I
Most of our communications have been by email, but also by phone. Directly with the lead auditors.
ISO 13485: 2016 and MDSAP, one of our sites had their audit last July and still has not received their certificate. We are looking into other options right now and were considering BSI. We wanted to see if other companies were experiencing similar issues.
 

Randy

Super Moderator
#4
Everybody has issues regardless, some possibly more than others. I don't do 13485 or MDSAP even though I have 2 of the largest blood & tissue facilities in the country for 9001 (blood isn't a medical device)
 

yodon

Staff member
Super Moderator
#5
As @Randy says, everybody is having issues now, especially in the device world with all the swirl around MDSAP, MDR / IVDR, and even Brexit. Be persistent and talk to your account rep.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Be persistent and talk to your account rep.
I agree that there is a lot of turmoil in the conformity assessment sector, but I disagree in the insistence to keep talking to the same rep and expecting different results. The issue has to be ESCALATED. When the account rep shows to be incapable of resolving the problem in a timely manner, the registrant has to elevate his dissatisfaction.

As mentioned a number of times, just visit the website of the organization you are dealing with and I am sure you will find some statements to the effect of customer satisfaction, business excellence, bla bla bla. Keep them accountable to it. Talk to someone at the top. Demand satisfaction, or the whole case, WITH NAMES, can end up exposed at Elsmar. That tends to resolve the issue. Talking to the same lowly account rep will just keep perpetuating the run around.
 
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