New Quality Manager Audit Preparation

Hi There,

I am a new quality manager and would like to know how to prepare for an upcoming external audit. What information do I need to have on hand to show the external auditor that I am in compliance with the standard for my department as a manager?

Thanks,

Trevor

Is this an ISO (9001?) audit? Are you the point person from your company for the entire audit?

What do your procedures say what you are supposed to do? (Rhetorical question, but start there for figuring out what they will ask for.)

yodon said:

Is this an ISO (9001?) audit? Are you the point person from your company for the entire audit?

What do your procedures say what you are supposed to do? (Rhetorical question, but start there for figuring out what they will ask for.)

Click to expand...

ISO9001/AS9100, and yes, I am the point person.

Were you not given any training on the standards or your implementation of them? (Another rhetorical question.)

Did you get an audit plan from the auditor? That'll tell you the scope of what they want to see. From there, map to your procedures and determine what evidence is needed to show them to demonstrate compliance.

Since it sounds like you haven't been through an audit before, you may want to search this site for matters on conducting yourself in an audit (e.g., only answering the questions, etc.).

1st it's a conformance audit not a compliance audit. 2 different worlds, 2 different things.......and there is a difference

You'll get an audit plan before the audit, that's a start.

You're next bet is to review previous audit reports.

Below is the minimum to expect on an annual surveillance audit from a document I have to follow (and every other 3rd party auditor has to as well)

Surveillance audit program shall include, at least:
a) internal audits and management review,
b) a review of actions taken on nonconformities identified during the previous audit,
c) treatment of complaints,
d) effectiveness of the management system with regard to achieving the certified client's objectives,
e) progress of planned activities aimed at continual improvement,
f) continuing operational control,
g) review of any changes, and
h) use of marks and/or any other reference to certification.

Welcome,
It's tempting to ask how you got the position if you have no idea what's involved in an external audit.
HAve you not experienced an external audit before? You need to be fully familiar with the relevant Standards against which you are being audited, and with your organisation's procedures and work instructions, and the records generated. You need to make sure that all relevant staff are briefed on how to conduct themselves during an external audit. You need to ensure that you have all the records required by the standards and your own procedures - are your internal audits up-to-date, management reviews held and documented, corrective actions closed etc.

You also need to refer back to the previous external audits on your current audit cycle and check that the nonconformances and observations raised have been addressed, (even if, in the case of an observation, that you've decided not to do anything yet....)

Don't be afraid to come back and ask more questions here, there's already some good advice above; the external audit, unless it's a full recertification audit, should only look across part of your operations and the scedule/program that the auditor has to provide you with in advance will give you a guide as to which areas will be audited.

Good luck !

TacitBlue said:

Hi There,

I am a new quality manager and would like to know how to prepare for an upcoming external audit. What information do I need to have on hand to show the external auditor that I am in compliance with the standard for my department as a manager?

Thanks,

Trevor

Click to expand...

OK there ya go, you've gotten some advice from people that have undergone audits by people like me and at least one person that actually is the 3rd party auditor (doing one today to tell the truth).

Right off the bat, based on your post, I detect a lack of competence on your part, opening up a really nice audit trail I'd follow like a hungry dog after dropped hamburger on a floor. The lack of competence on your part creates great potential for possible systemic failure should the opened trail be followed. Xin Loi my boy.

For an external audit, you are not going to be able to prepare paperwork in advance. The auditor is going to look for effective processes. You are the quality manager, but the maintenance manager, for example, plays an equally important role. HR as well. Training procedures must be followed. Production management, are the production processes performing as planned? If not what was done to improve? Did that actually work?

There are way, way, too many factors to prepare for in advance. If the standard requirements are implemented properly, an audit should be just another day in the office. They ask what you do and how you do it, and they sample random things to make sure. If you are trying to make sure everything is just being done "for the audit", its going to be a rough ride.

hello all,
I am trying to study for my AS9100D exam and I am looking for help. I am wondering if anyone can shed some light on how the questions will go? Is it more directed towards AS9100 or are there a lot of ISO questions as well?
thank you

KATE S said:

hello all,
I am trying to study for my AS9100D exam and I am looking for help. I am wondering if anyone can shed some light on how the questions will go? Is it more directed towards AS9100 or are there a lot of ISO questions as well?
thank you

Click to expand...

There are several threads in the AS9100 forum about the AEA test. If you search, you will find it. As far as the tests it focus on 9100 and 9101.