Berni

Registered
#1
We are planning to open Canada Market of a company which manufactures class IIa devices.

Our problem is that our Notified Body (SGS) is not accepting new clients for MDSAP.

What can we do? Is it possible to use another NB only for this qualification?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Plase note that NBs have nothing to do with MDSAP. Notifies Bodies are notified by the competent authorities of the EU to perform assessment of the EU requirements.

MDSAP use AOs (auditing organizations), which may also have the role of NB for Europe, but they are totally different stuff. You can use any AO you deem appropriate.
 
#3
Thanks for the clarification. The point is using our NB for MDSAP should save us time/money because the audit is at the same time than ISO ones.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Interesting.
I've had my issues with SGS in the past....

But they do say that they are and AO for MDSAP so I don't know why they wouldn't do that for you as they are already your NB.


Marcelo- can a single organization be both an NB and AO for one company?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
But they do say that they are and AO for MDSAP so I don't know why they wouldn't do that for you as they are already your NB.
Lack of resources (in particular, auditors, see below).

Marcelo- can a single organization be both an NB and AO for one company?
Yes, this is very common, but the thing is, for each of these "roles", different rules apply (for example, IAF rules for ISO 13485 certification, and MDSAP rules rules for AOs. The fact that MDSAP rules are more stringent means that there are fewer resources such as auditors to MDSAP AOs).

The point is using our NB for MDSAP should save us time/money because the audit is at the same time than ISO ones.
Sure, this is also very common, as I mentioned above, I just wanted to make clear that we are talking about different things (and rules) in these cases.
 

fialor

Involved In Discussions
#6
Thanks for the clarification. The point is using our NB for MDSAP should save us time/money because the audit is at the same time than ISO ones.
Berni,
Unfortunately it does not really end up saving you much money, and you have all your eggs in one basket.

The MDSAP process is very formulaic and will generally not be less than 8 full audit days even for the smallest manufacturer.
SGS may not be taking on new clients due to lack of resources, but you can still choose other CAOs (competent auditing organisations) who you may actually prefer to work with in the long run, perhaps even choosing to move away from SGS.

I have to confess that I use SGS in one of my businesses, and I find them to be one of the most non-straightforward NBs there ever was. And I say that knowing very well that we work in a complicated environment!
 

nozzle

Starting to get Involved
#7
I've read this with great interest. SGS are our notified body and have done everything they can to put us off MDSAP, we're still waiting for a quote despite chasing for 5 months. Maybe it's time for us to go down the AO route.
 
#8
Because there is such a demand for MDSAP certifications, from my experience with trying to find an alternate AO, from what was mentioned in a MDSAP webinar that I attended, and from Canada's notice that they posted stating that they realize companies are having difficulty scheduling MDSAP audits; most AOs are not taking in new clients and instead are trying to service the customers that they currently have. This delay in scheduling MDSAP audits seems very common with all AOs - which leads to frustration for everyone. So if you were to get accepted as a new customer with another AO, unless they tell you upfront that they can schedule you on a certain date, expect a delay with them as well.
 
#9
I've read this with great interest. SGS are our notified body and have done everything they can to put us off MDSAP, we're still waiting for a quote despite chasing for 5 months. Maybe it's time for us to go down the AO route.
They told me to wait at least 3 months for quoting us.
Is a very frustrating situation and at least until mid-2019 they have no plan for solving it due to the lack of resources.
 

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