SBS - The best value in QMS software

Audit Mandays for OBL/Virtual Manufacturer

M

Mor628

#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.
 
Elsmar Forum Sponsor

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. :(
 
M

Mor628

#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.
 
L

locutus

#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

Quite 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
 
M

Mor628

#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.
 
E

EthanLoh

#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 by a moderator:
M

Mor628

#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]
 
Thread starter Similar threads Forum Replies Date
B NB Auditor Rotation and Audit Mandays Duration Registrars and Notified Bodies 12
S How many mandays are required for QMS audit? Internal Auditing 5
G Integrated Systems Audit Mandays Duration - IAF Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Audit Mandays vs. Number of Company Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Auditors On Site Duration - Audit Mandays (ISO 9001) General Auditing Discussions 3
I How many mandays should the ISO9001 registration audit be? General Auditing Discussions 6
Marc Internal Audit Mandays - Is there a set, or minimum, number? Internal Auditing 4
K IAF Audit Mandays - 70 employee design office General Auditing Discussions 1
M 14001 Registration Audit Mandays ISO 14001:2015 Specific Discussions 3
K Survey Audit Days (Mandays) - TS 16949 IATF 16949 - Automotive Quality Systems Standard 6
K Number of Required Audit Mandays - TS 16949:2002 Registrars and Notified Bodies 13
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
B Remote IATF 16949 audit preparation IATF 16949 - Automotive Quality Systems Standard 9
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
xfngrs NIOSH Audit for N95 respirators US Food and Drug Administration (FDA) 1
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
salaheddine96 Internal audit planning Internal Auditing 2
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
Ed Panek Remote Audit GOTOMEETING thoughts Coffee Break and Water Cooler Discussions 22
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 12
M Audit Criteria Training Materials Internal Auditing 1
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
S Complexity Rating - CB adding another audit day for "high complexity" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom