Audit Mandays for OBL/Virtual Manufacturer

Mor628

Involved In Discussions
#1
Hi guys,

We have recently gotten our re-certification quote from the NB and they have quoted to audit us for 4 mandays. We a small company (OBL) with 10 ppl, five Class 1s devices and two Class II devices.

When we asked the NB to justify the claim, they said that the number is derived by a calculation based on the MD9 document, where OBL's are audited as a OEM (factory).

Does anyone know anything about this? Any additional information would be really helpful.

When pressed further, the NB simply said, we should look elsewhere if we are not satisfied with the mandays.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Unfortunately "OBL" is no more, and you'll be audited like a full-on manufacturer (as you've already described on another thread, your OEM - actual manufacturer - can be expected to be audited too, as your manufacturing arm; if their location is 3km away from you, they might want to go there during those "4 man days").

4 man-days (probably 2 auditors for 2 days) is a bit on the higher end for your scope, in my opinion, but I wouldn't consider it outrageous (are the "class II" devices IIa or IIb?). Consider yourself lucky being able to schedule a NB audit and communicating with an apparently responsive one. :(
 

Mor628

Involved In Discussions
#3
Dear Ronen,

Thanks for your reply. Yes, I suppose you are right. Btw, it is one auditor for 4 mandays. We have four Class Is devices, one Class IIa and one Class IIb.

Also, yes. I contacted MANY NB's and none of them were taking new customers as they are "reviewing their business plan'' or ''upgrading their certification''

I've dropped MHRA an email, so let's see what they say.
 

Edward Reesor

Trusted Information Resource
#4
At our last audit, we were informed that our next surveillance audit (introducing us to the MDSAP program in Canada) will include 2 auditors for 2 days each.

As one of my colleagues has stated a few times, "Increasing regulatory controls will be the eventual death of the small manufacturer". Already I have seen NB's and companies leaving the EU for a variety of reasons (Rev 4 and UDI requirements) and the FDA is increasing their fees dramatically.
 

locutus

Involved In Discussions
#5
Welcome to the "new world" of Notified Bodies. As Edward said, regulatory hurdles are going to be challenging for small manufacturers and companies wanting to develop innovative products. The shift may be that companies develop innovative products and before even getting on market they will try to sell their technology to bigger companies who can handle better the regulatory hurdles and costs involved.
 

Wolf.K

Involved In Discussions
#6
Yes, I think having a NB who prepares the reports without "undue delay" ;-) is a nice thing to have nowadays... We have our re-certification audit in two weeks, and still don't know if it will be according to 13485:2003/2012 or 13486:2016...
 

Randy

Super Moderator
#7
Hi guys,

We have recently gotten our re-certification quote from the NB and they have quoted to audit us for 4 mandays. We a small company (OBL) with 10 ppl, five Class 1s devices and two Class II devices.

When we asked the NB to justify the claim, they said that the number is derived by a calculation based on the MD9 document, where OBL's are audited as a OEM (factory).

Does anyone know anything about this? Any additional information would be really helpful.

When pressed further, the NB simply said, we should look elsewhere if we are not satisfied with the mandays.
According to MD-9 on page 28 4 days is correct. Increase or decease in duration can be justified in some cases. MD-9 is free on the internet, just type IAF MD-5 for the link to a copy
 

Mor628

Involved In Discussions
#8
Hi everyone, thanks for replying to the thread. I have just received a reply from MHRA, wanted to share in case anyone else has the same questions.
Note: Only applicable to UK based NB's.

Q: As the OBL, are we subjected to the same type of audit as an OEM? Even though we outsource all critical processes such as sterilization.
A: You should be subject to an audit but clearly there is no production for the NB to audit.

Q: Is the OBL audit mandays (a company of 10 staff) the same as the OEM audit mandays?
A: The NB should take into account that there is no production on site and therefore the number of man days should be less than that for the OEM.

Q: Is the IAF MD5 and MD9 reflective of a OBL company, which is not the same as auditing a manufacturing company with multiple departments and a larger workforce.
A: The guidance is normally used to work out man days but the NB should clearly reduce the time due to the fact that there is no production on site.
 

EthanLoh

Involved In Discussions
#9
I used to work for a notified bodies and our re-certification man-day for 10 employees is 2.1 man-day.

However, if you have MDD and technical files to be reviewed, there are additional cost.
- MDD + 0.25 man-day
- Technical file review: 1.5 man-day (per file)
- Since you have 5 Class 1s devices and 2 Class II devices, I would normally select 1 class Is and 1 class II for review.

Total: 2.1 (QMS)+ 0.25 (MDD) + 3.0 (TF) = 5.35 man-day (5.5 round up) If you are a good client, give you a 10% discount :D

1 man-day is about Euro 1800

Overall, I think your NB is considered "Value for money". Please treasure them.
 
Last edited:

Mor628

Involved In Discussions
#10
Hi all,

Just a quick update, I got in touch with ZLG and they agreed that the mandays were excessive. Below is the reply:

"for the audit duration time all accredited certification body in Germany use the IAF MD 09:2017 issue 3 for initial audit.
If the customer has no design, no production and only outsourced process (like PLM) the audit duration time was reduced, but not more than 20%."


They even called up the NB and got them to re-issue the quote. Took a really long time for them to respond, but glad we got some answers anyway.

If you need to get in touch with them, email [email protected]
 
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