Auditing Organization dragging their heels on issuing our MDSAP Surveillance Audit Confirmation Letter - everyone is nervous ... are we the only ones?

#1
Does anyone have the inside scoop - are all the NBs slammed this year and just trying to grind it out? Our customers are getting antsy about placing orders ... and the NB failed to respond completely for a month, then punted to another team without providing any good response. Thoughts? Ideas? Strategies?
 
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Edward Reesor

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#2
I believe they are called AO's (Auditing Organizations) and not NB's, but we still haven't had our Correction Plans officially accepted. They were accepted by the Lead Auditor but then they were to go to the company for final approval, and haven't heard anything since. Our NC's were pretty minor and the plans were pretty simple, but that's not the point.
 
#3
Sorry - AO. They just ignored us for a month, then responded with a "hot potato" but the person to whom the other person threw the "hot potato" was copied on all correspondence already. How hard can we push? Are there consequences to "getting tough" with them. I didn't even ask for them to commit to a delivery date (assuming we're ok) for the documents - just to give us a non-binding ballpark and to confirm they were not aware of any problem that will prevent them from issuing the document in for us to submit to Canada.

The answer was, "Oh, just got this [despite being copied on all emails], we'll get back to you [unspecified date]."

Our management is getting hyper, our customers don't want to place orders - how is this sausage being made?
 

Edward Reesor

Trusted Information Resource
#5
Coincidentally, we just received our confirmation that our Corrective Action Plans have been approved. Please keep in mind that the AO's have been given a very tough task to the extent that the Health Canada has made many accommodations for companies to become certified. I would be very interested in the numbers as to how many companies withdrew from the Canadian market solely because of this mess.
 
#7
We have been having serious issues with our AO. Lack of responsiveness, inability to keep dates previously provided and provide new dates, they just can't keep resources.

On the Canadian side, we have licensed class II devices and no longer have a confirmed date for MDSAP. We have been communicating with our AO about MDSAP from day 1. I talked with Health Canada directly, they indicated they aren't going to be cancelling our licenses - even when I indicated we might need to drop MDSAP from our plan for 2019.

My overwhelming concern is our 13485 cert, the resource strain has impacted scheduling our recert to 13485:2016 and they can't tell us when they are coming.
 
#8
Glad the regulator seems to be demonstrating some willingness to be flexible. I wonder though, whether they have this discretion or authority.
 
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