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
N API Q1 Audit Surveillance - Questions Oil and Gas Industry Standards and Regulations 2
A Alternative to on site audit in China EU Medical Device Regulations 2
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
B Internal audit checklist Internal Auditing 5
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
J Internal Audit Schedule IATF Internal Auditing 3
Mikey324 External calibration - Finding in our 3rd party audit General Measurement Device and Calibration Topics 58
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
J Stage 2 audit initial cert, few data points ISO 13485:2016 - Medical Device Quality Management Systems 4
S Corrections not allowed during audit ISO 13485:2016 - Medical Device Quality Management Systems 7
P Looking to outsource Internal Audit - MDSAP competent auditor needed Other Medical Device Regulations World-Wide 9
R GFE Audit - Violation? GFE Location Controls AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
I Audit is tomorrow but I refused to participate Misc. Quality Assurance and Business Systems Related Topics 16
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Re-labeler - audit the supplier EU Medical Device Regulations 2
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
A PPAP question for audit APQP and PPAP 16
D Number of people to be interviewed during an internal audit? Internal Auditing 10
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
S Quarterly Dose Audit Medical Device and FDA Regulations and Standards News 5
H When is a SOC 2 audit necessary? IEC 27001 - Information Security Management Systems (ISMS) 5
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
A IRIS audit - Discussion about Special Processes General Auditing Discussions 11
J Internal audit random sampling methodology Internal Auditing 2
D Major NC from last audit not fixed not sure how to fix General Auditing Discussions 10

Similar threads

Top Bottom