NB Auditor Rotation and Audit Mandays Duration

I thought that I had read somewhere that notified body auditors were now required (not just suggested) to rotate every three years. However, I can't find that written anywhere now. Also, my notified body manager indicates that a company of my size only requires 2.5 days for recertification. However, the auditor has scheduled 4 days. They have spoken to each other and the manager defers to the auditor. However, the auditor takes very long because she chit-chats a lot and always takes an extended lunch. Why is my company required to pay for extra days when it is the auditor that can't stay focused?

Any suggestions? Thanks!

Re: NB auditor rotation and audit duration

Unless some situation exists I'd formally request a new auditor. Over the years I have been involved with a new auditor every visit, to a single auditor over a period of time. The best set-up I had was a semi-annual visit by two different auditors one who tended to be detail focused and the other big picture focused. They kept us focused on the system, but also challenged us to think about how we did things.

I'd also ask for the justification for the extra time. The time periods are specified for audit days and can be modified, but they need some reason why. An extra day and a half does seem excessive.

Re: NB auditor rotation and audit duration

I think that is a requirement for ISO/TS 16949 (automotive), but not for other standards.

Re: NB auditor rotation and audit duration

I guess I should have mentioned, we are a medical device manufacturer certified to ISO 9001, ISO 13485, CE marking and CMDCAS.

Re: NB auditor rotation and audit duration

isoalchemist said:

Unless some situation exists I'd formally request a new auditor. Over the years I have been involved with a new auditor every visit, to a single auditor over a period of time. The best set-up I had was a semi-annual visit by two different auditors one who tended to be detail focused and the other big picture focused. They kept us focused on the system, but also challenged us to think about how we did things.

I'd also ask for the justification for the extra time. The time periods are specified for audit days and can be modified, but they need some reason why. An extra day and a half does seem excessive.

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Excellent advice. You are paying them; you're well within your right to ask these things.

Re: NB auditor rotation and audit duration

BigManP said:

I guess I should have mentioned, we are a medical device manufacturer certified to ISO 9001, ISO 13485, CE marking and CMDCAS.

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Medical Device Notified Bodies are under increased scrutiny by the European Authorities and are struggling to keep up with auditor competence requirements and additional scheme requirements.

Your situation might be one of those where the auditor that you know is one of very few qualified for the job and, if you tell the Notified Body to assign your audits to another auditor, they might not have another one, close to you; so you might see auditors coming from far and away, driving your audit costs way up.

I don't condone the unprofessional behavior your auditor exhibits and she might be "prolonging" your audit so she gets paid for more audit days, in case she is a contract auditor with the NB.

The fact that the NB management is willing to defer to her the determination of audit-days necessary for the audit seems to me that they are afraid of telling her what to do and she quitting the contract job.

Some auditors that have some very desired qualifications and competence are able to commandeer their price, clients, audit-days, etc... and the NB is scared to death to rock the boat because, if they lose that auditor, they are in deep youknowwhat to service a number of clients. So, they are at the mercy of the auditor, somewhat.

Good luck.

Re: NB auditor rotation and audit duration

Thanks for all of the great feedback. I do want to give my NB a piece of my mind, but also don't want to shoot myself in the foot! I guess I will proceed cautiously and see if I can make some headway. Thanks again!

BigManP said:

I thought that I had read somewhere that notified body auditors were now required (not just suggested) to rotate every three years. However, I can't find that written anywhere now.

Any suggestions? Thanks!

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You weren't imagining things

It's on page 16 of the Notified Body's Code of Conduct (version 3.0, dated 10 October 2012). The new minimum audit durations are described there too.

I hope it worked out for you!
Karen

hi,
we're a Sales and Distribution office (all pen-pushers here) struggling with the same thing - our Aerospace team with 2 people in it got a TS audit for a whole day. I was considering bringing in Scrabble

I heard the same about TS auditors: that they're only allowed to audit the same company 3 times.

Is there anywhere in TS standard / any associated document where it says this and how they calculate how many man-days they'd need?

Much appreciated.
Lil

Hello Lil,

Yes for ISO TS your auditor will be the same for one cycle (three years), then you will have to change (although in unusual circumstances you can ask for a deviation to keep the same auditor).

In the ISO TS rules for achieving and maintaining IATF recognition - Sorry copyrighted document otherwise I would upload a copy - it explains audit day calculation; which is a sliding scale based on the number of employees in the company, whether you do product design, etc.

Your certifying body should be able to explain the man day calculation to you for your case.