Final ISO 9001 Audit - What questions will they ask - Help and advice needed

[ashujanu]

We are having final audit in next 12 days. In our initial audit, there were 6 NCs. I don't know what to do. None of the NCs are related to MR / HR work.

I am worried what questions they will ask. They want external origin document list since october 2008. our's is a merchant trading firm. i have made the list

A) certain BIS requirements,
B) regulations/acts/codes - related to products
C) Electronic / printed Drawings
D) CDs received from the suppliers
E) Regulatory, & Statutory Standards
F) Customer specifications documents
G) MSDS
H) Certificate of Analysis / Health Certificate / Phytosanitary Certificates / Fumigation Certificate
I) SGS / Geochem inspection reports
J) Equipment maintenance manuals (instruction manual)
K) Manufacturer's manuals (brochures)
L) Tender documents
M) Quotations received from supplier
N) Counter bids received from the customer
O) Electronic / Printed drawings received

i dont know from where i should get

A) certain BIS requirements,
B) regulations/acts/codes - related to the products
E) Regulatory, & Statutory Standards

can someone help me out with the above? and also if I have missed out some documents.. then also pls inform me.

regards

ashwini

[Colin]

Welcome to the Cove.

I am not sure what you are asking here. You ask about the questions they will ask but your list appears (to me) to be a list if documents/records - in other words, evidence.

The auditor will (should) ask lots of questions in asking you to explain how you operate your processes and ensure that conforming product/service is provided to your customers.

To demonstrate this you will need to provide evidence - hence the list you have provided.

[Jennifer Kirley]

Welcome!

If you are not sure you have properly addressed the NCs, I encourage you to ask your registrar.

It seems scary to have six NCs from a preliminary audit, but that is not a huge number.

Regarding external documents like requirements and manuals (tenders are internal process documents), the auditor will ask how you keep current with them, how you make sure they are controlled against loss, how you make them available to people who need them, and how you archive the outdated versions to ensure they are available for reference, but will not be inadvertently used for processes.

Try not to worry . If you are not sure what the auditor is asking for, just say so.

[Randy]

In Reply to Parent Post by ashwinirane

i dont know from where i should get

A) certain BIS requirements,
B) regulations/acts/codes - related to the products
E) Regulatory, & Statutory Standards

can someone help me out with the above? and also if I have missed out some documents.. then also pls inform me.

regards

ashwini

If you don't know by now it's probably too late and it also demonstrates some not so good conformance to 7.2.1

[AndyN]

I'm confused by this OP:-

They (who?) asked for a list of external documents - last October?

The initial audit? Is this a CB audit? Was it last October?

The final audit is in 12 days? Is this a corrective action closure? Or is it a partial re-audit, because you failed the first time?

What's MR/HR work? What do you mean by this?

Are you the Quality System management representative for this organization? Or are you trying to fix this on your own?

We need more information before we can help stop what sounds like a panic attack!

[ashujanu]

Hi everybody, thanks a lot for answering to my query. Now I think that I should have put my query in more proper details..

what i had meant to say is:

though i know what external documents are required, but i dont know from where i can get them say for e.g. statutory & regulatory requirements . for this what documents i should show.

the list of external documents was asked in the first audit by the auditor. initial audit means stage-1 audit, it was informed to us that after the initial / stage-1 audit, they will give us approx. 10 days to close the ncs, and then afterwards there will be main audit. they wanted to see where we stand right now for getting certification. we started working out on iso 9001 QMS in the month of august and in the month of ocotber, we prepared our final central procedure and quality manual. we have got 3 other different divisions for whom we have prepared quality plan.

see i am the management representative for the company. i have not under gone any formal training. we have got a senior coordinator who tells us all what to do.. he is okay, but has got a bad habit of yelling/ shouting loudly at everybody. i have read the iso 9001:2008 manual many times, i have understood it also, but to talk / write in technical language i am finding it difficult. same way while writing corrective action. i know what to write, but how to put it on paper using the technical language is a bit difficult. and our coordinator talks as if we all know everythng about qms. he has been doing this work since the past 11 yrs or so.. whereas we have started just now... just because i didnt know the technical language, at the time of initial . stage-1 audit, i was asked not to reply to any questions of the auditor, but just sit quietly and show him whatever documents are asked for by the auditor and our unit head and the coordinator will reply to the auditor's query. the auditor was informed that i am the mr. it was done that way and now the auditor in his audit findings have used the words "The Management Representative needs to be more versed with the requirements of the standard as well as the organization's own system documentation. "

so basically my query was as to what documents should i list as well as show to the auditors in the statemetn document of external origin

what questions will be aksed to MR in the main audit now.

i hope i could answer all your questions.

bye and thanks again for your reply.

regards

[meongroup]

You are clearly in a situation devised by someone else to prevent them being caught out!

Suggest you do the following.

1. stop worrying
2. gather all the documents you believe you need, and maybe some you think might be useful
3. when the auditor comes explain that you are not clear what the previous auditor was after, but you are here to do the best you can
4. if you fail to understand what is wanted, say so. It cant get worse.
5. if the auditor is dissatified by anything you provide or fail to provide, tell him you are handing this aspect over to your collegue who will explain what you dont understand.

Remember just one thing. The auditor is a supplier, not a customer, and stop panicking!

[Randy]

Below is the only guaranteed question, all others will be based upon how the one preceding it was answered.

"Good morning, how are ya'll doing?"