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Quality Audit for renewal ISO 9001
2

Quality Audit for renewal ISO 9001

Quality Audit for renewal ISO 9001

(OP)
Hello everyone,

I have recently joined a company as quality manager. We have to perfrom a renewal of our quality certification ISO 9001. This is my first time to face an audit. I was studying some books by ASQ and following some courses to prepare for the audit. The company also has a consultant to help out in the audit. The consultant has around 40 years of experience of this. He has asked me to prepare the documents like customer request, offer by the company, signed contract, approved designs and purchase orders of materials for 5 or 6 big orders.

But this has got me confused, I was expecting that the auditor will be going in to our quality procedures and processes and approach of implmenting them, risk analysis, matrices, quality objectives etc. How is this list of documents enough to pass a renewal audit? The consultnat is not so much willing to explain to me, he just says trust me this is all we need. Is this a normal procedure?

RE: Quality Audit for renewal ISO 9001

Your approach of reviewing the underlying procedures and demonstrating that they are followed makes sense.

RE: Quality Audit for renewal ISO 9001

The QC manual is only one and does not depend on what the client asks for or if it is for 5 or 6 large jobs.

Regards

RE: Quality Audit for renewal ISO 9001

Much depends on the auditor.

A former company of mine used Q****r here in Ontario and it was a joke. The 'auditor' was a kid in his 20s and who probably never had a previous job in industry, sat down with a single person for a few hours, spoke to no one else, and as far as I know did not look at any document past the QA manual (which, to be honest, you can find on the interweb).

YMMV

"Everyone is entitled to their own opinions, but they are not entitled to their own facts."

RE: Quality Audit for renewal ISO 9001

My experience was (in 2 companies) that the QA department prepares all the documents 10 days before the audit, then everything continues with the same errors.

Regards

RE: Quality Audit for renewal ISO 9001

2
In a nutshell, ISO audits you on being able to consistently doing what you say you're going to do - and have documented proof that you did so. The purpose behind the consultant asking you to have the "in process" documentation prepared is that the external auditor is going to take you through quite a few of the steps for a specific order (or 6). If there is a discrepancy somewhere, then the digging goes a bit deeper into the actual procedures and "checks and balances". You WILL get asked for documented evidence of meeting the customer specification, for example. Was that by calculation? Show the calculations and personnel qualifications for making design decisions. Was it by factory acceptance testing? Show the tests performed, the testing procedures, and the personnel qualifications. Was it some other method? Show the paperwork to prove you did it - correctly. How do you control design documentation? Where does it reside? Does everyone involved know where to go to get the latest revision? CAN they go and get the latest revision? Which revision did they use when manufacturing the part/assembly?

Converting energy to motion for more than half a century

RE: Quality Audit for renewal ISO 9001

I’m with Gr8blu on this one. That’s our experience as well.

Huub
- You never get what you expect, you only get what you inspect.

RE: Quality Audit for renewal ISO 9001

I also agree with Gr8blu.

Objective evidence, in the form of documents generated in the course of past contracts, is a great way to demonstrate that procedures are followed.

However to me the listed documents, customer request, offer by the company, signed contract, approved designs and purchase orders of materials, will not get the job done.

Perhaps those are just examples of a much more extensive list that the consultant gave you?

RE: Quality Audit for renewal ISO 9001

When every mon'n'pop machine shop along Industrial Drive displays a 9001 banner, what does it even mean?

"Everyone is entitled to their own opinions, but they are not entitled to their own facts."

RE: Quality Audit for renewal ISO 9001

I agree with Mint Julep on this one. Its is not like the old days when someone from Adm. Rickover's staff coming to visit. I know for some of you that comment means nothing, but it is a tidbit of history on naval nuclear quality programs so long ago.

RE: Quality Audit for renewal ISO 9001

I owe my gainful employment in the mid 90s to the esteemed Adm. Rickover!

"Everyone is entitled to their own opinions, but they are not entitled to their own facts."

RE: Quality Audit for renewal ISO 9001

Yes, and I also owe a portion of my employment to the esteemed Werner Von Braun who was just as big of a PIA as Rickover. I am just so glad I never had to deal with either of them directly. That said, the one indirect boss I really liked was Tom Kelly of Grumman. He was saddled as a young engineer to head the building of the Lunar Entry Module for the Apollo space program. I worked under him as a contractor to salvage NASA's Space Station Freedom program before it was terminated in 1991. He was a very polite man, but I swear you could smell the oil burning in the cogs of his mind at a staff meeting.

RE: Quality Audit for renewal ISO 9001

The admiral left a lasting legacy, but it was cut short by SCC and alloy nationalism. I think you know what I'm referring to!

"Everyone is entitled to their own opinions, but they are not entitled to their own facts."

RE: Quality Audit for renewal ISO 9001

(OP)
Dear all,

Thank you for a great dscussion. In the end the audit was as described by Mr. Gr8blu. The auditor cheked some of the documentation of the orders to verify if we in reality implement what is written in the procedures. He did not go too much in detail in to the procedures as he has a historic record of audtiting our company for 10 years, so he has seen all the written processes in past.

We had prepared very well for audit, but like Murphys law, during job shop visit the first vernier calliper that the inspector took for verification, was the outlier i.e the calliper that my colleague of instrumentation forgot to update the calibration certificate. All the remaining 13 callipers had the updated certificate, but he did not bother to check any further. We had to demonstrate our procedure and instrumentation register etc to satisfy the audit.

RE: Quality Audit for renewal ISO 9001

The ISS was a great program to be working on; there are engineers that spent their entire careers working on it, through at least 3 major redesigns.

Congratulations on passing the audit; one lesson learned is that KISS is the way to go. The more complicated your procedures are, the more likely you'll have failed to follow something to the letter.

TTFN (ta ta for now)
I can do absolutely anything. I'm an expert! https://www.youtube.com/watch?v=BKorP55Aqvg
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