Pre-assessment Audit Worries for a Newbie

R

Random

#1
Hi, I'm new to this site, and the whole area of ISO 9000. I just got out of college and took a position as a Quality Manager in a small manufacturing plant, with my first task to pick up where the previous QM left off on ISO 9000 certification.

We have our Pre-assessment audit coming up pretty quickly, performed by our registrar, and was hoping to get some information on what to expect. Is the auditor going to be looking at just how we carry out our processes, will he be looking at our documentation as well, etc. We're having auditing training right before the pre-assessment, but since both myself and the plant are new to all of this, I thought it would be better to experience this first to get us an idea of what happens during an audit, and how we can go about it internally.

Having gone over the requirements and a couple different interpretations, I feel that the areas we have to work on are documentation, control of documents, and using our records to improve (instead of just filling up folders.) Any help would be appreciated, and thanks in advance.
 
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B

Bob_M

#2
Welcome.
First try to relax. (It may be difficult but it is possible).
Our (upgrade) pre-assessment was very basic. We sent a copy of our Quality Manual and 6 Required Procedures to our auditor for off-site document review. During the visit the auditor basically looked for and discussed the "process flow" and whether or not our system as a whole followed the ISO 9000:2000 Structure. Our registrar expected to see 1 minimum Management Review Meeting records and a full audit cycle to the new standard.
During the registration audit, the auditors will be looking at the details and records, and interviewing personnel.
The pre-assessment is a tool to judge how close you are to being ready, and giving you the chance to fix the major/minor problems before the registration audit.
Search the rest of this site for plenty of helpful general and specific topics.
 
#4
I agree, welcome to the Cove!!! :bigwave:

Use the pre-assessement the way it is intended. You will find that there are a few issues you didn't even think of. That's okay. Make the changes, ask us questions, and then go for the registration audit. Once that is behind you take a year of vacation. :smokin:
 
C

Craig H.

#5
Hi, Random, and welcome!

I think, looking back on our experience in our early ISO days, that it is important to not only look at what ISO 9001 is, but also what it is not.

If your company is a going concern, without an undue number of errors, then try to capture what is being done. There are 6 "shall" documentation requirements, but you will most likely need more. Don't make the mistake of going overboard, though. Just give the floor people what they need, in a format they will USE!! If you hear someone say that you need a particular item or record, don't be afraid to ask where that requirement is in the standard. As one of our members is fond of saying "Show me the 'Shall' ".

As far as what your auditor will look at, yes, he or she will likely look at both documentation and your process as a whole (and subprocesses, interaction, etc.). Starting out with a process map should help you understand these, and I suggest drawing your process map very early in the process of getting ready to go for registration.

You have come to the right place. Just use the search function, and ask when something isn't clear.

Oh, yeah, and try to relax.

Craig
 
G

Greg B

#6
Random,

I totally agree with both Bob and Craig.

Relax...They can't shoot you if it is not up to scratch. A QA system is a work in progress. It can never be 100% correct as it is continually changing....when the registrar does the audit don't worry if they pick something up (they always do) use it as a tool to improve your system.

Greg B
 
C

Craig H.

#7
Greg B said:
....when the registrar does the audit don't worry if they pick something up (they always do) use it as a tool to improve your system.

Greg B

Greg:

Indeed, unless you are an auditor (and some of those types have been known to lurk here)

:vfunny:

THAT is the whole idea of this exercise- to improve the effectiveness (competitiveness???) of the company. Not that the "dings" are welcome, but they do provide a guidepost to where we could do better, if we have a good auditor. They (dings) are going to happen. While I am proud of the 1 (read that, ONE) time our system has escaped without a nonconformance, I would be remiss in my duties as QA Manager if that continued without me wondering if we were getting our $ worth.

OK, either that, or I am (we are) perfect.

Well, I was that once, but the market (or situation, personnel, raw materials, procedures) changed.

Yeah, right.

Random, you have managed to insert yourself into a place where you can either decide to just go for the cert, or use the effort to drive positive change. Choose the higher path, learn the standard, and figure out where your present system does not conform (gap analysis). Then, make it happen. Your company (and you, I hope) will be better for it.

Craig
 
R

Random

#8
Thanks for the for the advice (especially the relaxing bit)

I sure that we'll get some non-conformances identified, but that's what I see as the good part of the pre-assessment. Get those identified, along with any areas that conform but can be done better, and get them in shape for the real assessment.

Here's hoping that everything goes smoothly.
 

gpainter

Quite Involved in Discussions
#9
Don't worry be Happy :D . Your fresh out of school and was able to find a job. Pre-assessement(Gap Analysis) is an excellent tool for you and the company. Watch, Listen, Question, Learn and take plenty of notes, but remember it is your system and not the auditors. They will more than likely find plenty of N/Cs. If you take care of all of them you will find the registration audit a lot easier. Do get some info on your registrar and auditor, get their checklist(most do still have one but are not used as much), talk to some people that use them (people here). If you have any questions just ask at the Cove. Most are happy to give their 2 cents worth, many give 3 or 4. The best thing about it is it is free and experience based.
 
R

Randy Stewart

#10
Don't sweat the small stuff and don't take it personal. Think of it as just another set of eyes looking it over, like having someone read over your term paper! :thedeal:
 
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