I have it on very good authority that the third party audit we are scheduled for will be conducted in the following manner:

The quality manual and procedures are bench audited against the standard. Barring any discrepancies in the manual, the standard is then "thrown out" and the organization is audited to the manual.

I've toiled over my quality manual and its treatment is light, to the point, and readable. I've used the manual to explain treatment of requirements that is not provided elsewhere, and references to the written procedures that are needed for this company to hold itself to the standard. I have left out such things that are granted, such as "this organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 9001:2000." I feel this statement in a quality manual is completely regurgitive and by the manual's existence, self-evident.

This little bird says that it is important to capture the standard in the quality manual and that the structure should be very close to the structure of ISO 9001 itself. This is how we will be audited.

I have swayed back and forth for ages trying to reconcile these two outlooks, and I realize it is impossible.

In physics, if it is not forbidden it is compulsory. The beautiful majesty of matter is profound. More and more of this idealism and respect for ISO 9000 is falling away from me. I have written so many different quality systems under different understandings, interpretations, and viewpoints, that I am again lost as at the start.

How can I possibly proceed?

I would be less concerned with who and how your manual will be audited, and more concerned with how well your QMS works. You are not building your QM for your auditor, you are building it for you. You can regurgitate the standard all you want, and your QMS may still be a mess. The only thing I would be concerned with is that each shall in 4.2.2 is covered by your QM.

By staying with what you got. ;)

Dont listen to little birds who claim to be good authorities !

ISO9001:2000 tells you what to put in a quality manual, what anyone else tells you is pure opinion.

Dont listen to little birds who claim to be good authorities !

ISO9001:2000 tells you what to put in a quality manual, what anyone else tells you is pure opinion.

I responded a minute ago, but it never showed up. This is simple stuff. Just do what the standard says. :agree:

I am not an experienced quality professional. I have never before worked with standards or documentation. I have never seen ISO 9001:1994 or HACCP or any other such thing. My experience with external regulation is limited to talking to USDA inspectors when I was a QA at a poultry plant.

When I look at the standard, it looks like I've got

1.) some areas to cover in terms of liability and organization, things like document control and gage calibration, job travellers calling out inspection requirements, methods call out for any second operation before the part is first opped. simple things to cover, clobber, and set in motion so that I can get to

2.) stillwater deep management tools that teach us and empower us to become very very good at what we do, to observe part 1 and to move it toward the vision. to let part 1 provide us with data that we can turn into information for the betterment of our company and our product.

I don't see anything else.

This company has a customer that is requiring registration by December 15th. (they accept audit findings and a letter of recommendation, of course.) I have pushed out our audit date at least 5 times, reworking and re-engineering my treatment of the standard. The fact is now that we must pass our audit on the first try, we must be recommended for registration.

I feel completely sure that our auditor will have some questions about the structure of the manual. I was going to send it on Monday, and now I'm once again terrified and confused. I tore it half apart so far this week, again trying to reconcile the two ways to do the manual. Capture the standard and write a company document that we're going to want to use, I swear that it isn't possible. not here.

When I try to capture the standard, I end up with nothing, the standard hardly restated. When I write the quality manual to address ISO 9001:2000 as I have come to understand it, in all of its requirements and in all of its process approach, I have nothing of the standard in it.

I'm beginning to believe that a standard regurgitive QM and a usable QM are mutually exclusive. Forbidden, impossible. That which is not forbidden is compulsory. It is one or the other, and no other way.

I have the standard, I have 6 different copies of it, I don't need to restate it in my QM. I fully believe that the manual should be what it really needs to be, which is in fact the structure of the quality management system.

What is going to happen to us? Am I going to face losing a customer because of this? This is my father's business. This company is his retirement plan, this is his neck. 15 people work here, how many will after my little experiment with ISO interpretation?

What appeals are available to us if the auditor is completely old fashioned or picks the system apart because of my approach? Is this going to anger the customer if we lapse, cannot achieve recommendation before the deadline?

Is it worth going crazy over this? I'm about to write TWO manuals now, one for us and one for the auditor.

What does experience really say about these situations. What will happen if I really am presented with the worst case scenario?

Don't go crazy! In my opinion here is what you need to do. Use your quality manual the way you need it to be. If you have to, take one copy of your standard, and at every "shall" indicate where the auditor can find evidence that the shall is being met. Include that as an appendix to your quality manual.

You might want to call your auditor, and get their feel about the situation. Most every auditor I know would rather you have a document that is real than a fake regurgitation. If they want the qm to copy the standard, then get a different auditor (if possible).

The appeals process is realitively simple. Should you and the auditor not agree, the first appeal is the to auditor. It is the auditor's job to show what "shall" is not being met, and why it is not being met. Force the shall ! Have the auditor quote the shall and the evidence must be clear that the situation is nonconforming. If you get nowhere with the auditor, then the appeal goes to the registrar. From there, it goes to the RAB. Most auditors and registrars will tend to side with you, if you press it (unless you are clearly out of line). They do not want you to go to a different auditor or registrar. Remember, you are the customer , you might need to remind them of that.

I've got to apologize for dragging this through all of the dirt. I don't expect you or anyone to accept moral liability for advice and guidance given. I fully respect this forum and I know that its users come here to discuss this and other quality standards, and I appreciate your willingness, determination, and integrity in holding ISO 9001:2000 to itself.

When I look at the standard it is with fresh eyes. It fits together in only one way, and documents that are not necessary for the effective planning, operation, and control of its processes should not be within the quality management system ISO 9000 creates.

is it the job of the quality manual to explain our treatment of each line item of the standard?

"this is simple stuff" db, I understand that.

I can live with that. I have a gigantic responsibility to live up to here, and I've gotta know that I'm doing the right thing. What's buzz buzz buzzing in the back of my head is "do it the way they want it"

"get it over with, Erik"

"change it later"

"get registered first"

:X !!!!!!!

I just wanted to tell you that you are not alone. I to have to be registered by Dec. 15. I have not finished my first draft of the quality manual and it seems impossible. By the way, it is not a regurgitation, but something I hope we can use. What I can tell you is listen to the people on this site and pick and choose the information that you think will help you. Also, talk to your registrar, they should be able to give you some guidance without getting into consultation.

I've got to apologize for dragging this through all of the dirt.


Don't apologize. Just as Mike Smith said: "you are not alone". By binging your "dirt" here, you help others as well. Most of the folks here began by bringing their dirt here.

We also have some ex-Marines here that love to roll in the dirt! :vfunny:

ok ok.

heh, ok. exempt my second post.

db. I wasn't sure at first if I had moved into an area that could cause problems for an auditor.

Mike Smith, that's exactly what our auditor did. He gave me a feel for his take on the situation, like db said, but he's very careful to stop before giving any consultation.

I really like this guy, I've talked to him a few times. He's going to be contacting me again soon to confirm our schedule.

I'd like him to be able to give consultation after the audit, after he's seen the business and can make suggestions.

However, he did tell me that I should capture the standard, not stray from it. This pertaining to the structure of the quality manual.

I'm ready to go with this but on that point I am stuck! I cannot proceed until I know if I should request a new auditor, go with the flow, or stand up for what I believe in.

Mike Smith, what industry? I'd be willing to show you my work, on the manual or on forms/records/etc.

I've got to apologize for dragging this through all of the dirt. Don't... We have all been there or will be very soon, and the number of responses to your post in such a short time must be an indication that your concerns are valid.

As long as you cover the shalls in 4.2.2 you will be ok as far as the QM is concerned. Be sure to note what 4.2.2b tells us: the documented procedures established for the quality management system, or reference to them.

Meaning: You can choose to have the documented procedures in the manual if that fit's your needs, but you don't have to. Do you by any chance already have valid procedures in place outside the manual? If so: reference to them. Don't duplicate or regurgitate...

Should you choose to use the reference route the only thing will happen is that the 3:d party will follow your links to the rest of the QMS.

In a QMS, if it's not compulsory you do as you see fit... ;) Tailor it to your needs. And hey... Good luck.

/Claes

We also have some ex-Marines here that love to roll in the dirt! :vfunny:

Actually it's mud :vfunny:


Don't go into overkill here. If your manual is more than a few pages long start tossing the trash, plain and simple. Basically your manual is just an outline with maybe a wee bit of fluff to give folks a warm fuzzy. I never expect these things to be massive things like the Congressional Record, as many are unfortunately. Your manual should not be the cause of hernia's to those that use it. If all else fails use one of the things that some of the fine folks here have provided as a format or example.

Trust me when I say..."This ain't rocket science". I know that because I used to work with rocket scientists and this isn't what they do. ;)

There is an old acronym "K I S S" Keep It Simple Simple (I don't use that other word much)

What is going to happen to us? Am I going to face losing a customer because of this? This is my father's business. This company is his retirement plan, this is his neck. 15 people work here, how many will after my little experiment with ISO interpretation?

What kind of customer would you lose, that you are providing good products or services to, just because you didn't get registered the first time audited on an arbitrary schedule?

Your customer will not drop you if you show progress. That would be foolish of him.

Based on the assessment, you will have things to fix. You will fix them and be registered. Don't worry, it's not the end of the world. Just keep your eye on the ball!

As I see the situation, atetsade is stressing over trying to capture several levels of Quality Documents in the second level [tier?] which most folks call a Quality Manual.

I agree with the comments which call for creating an appendix which describes how the organization addresses each of the "shalls" in the ISO9K2K Standard. The shalls may be addressed by procedures, work instructions, etc., but do not have to ALL be included in the Quality Manual.

I agree even more with the comment that it is most important to have a Quality Management System which serves the purposes of the organization.

I'd also like to take up the topic of the oppressive customer who makes registration a condition of doing business. This smacks of laziness on the part of the customer who is loathe to perform a customer audit to determine whether atetsade's organization can provide adequate product or service.

I have yet to see ANY organization which immediately became a better supplier by virtue of registration. In fact, except for the hassle of defending liability lawsuits for damage to someone's reputation, I would write names of companies with whom I refuse to do business, despite the fact they have ISO9K2K registration from "name" RAB registrars.

As small as atetsade's organization is, it can't possibly be a "prime" to loom so high on a customer's radar.