One the one side, we have those persons that say "If the Quality Manual says basically what the ISO says, Management has not demonstrated that they have a good understanding of what a QMS is, nor have they taken ownership of their QMS." In fact, I have heard many use the word "lazy".

On the other hand, I have seen remarks where professional QMS personnel have said that they have had a 5 page Quality Manual, and their external certification auditor said is was "The best interpretation of the intent of ISO9001:2000 that he had seen."

Then we have the requirements of ISO 10013, if we haven't forgotten that norm.

So lets do it everyone...

Let us decide once and for all the purpose and content of an excellent Quality Manual.

The best quality manual is one that reflects the way business is performed at the company. One of my customers wanted their procedures rolled up in one quality manual and they were happy to have a quality manual of about 35 pages and no procedures.

The best quality manual is one that reflects the way business is performed at the company. One of my customers wanted their procedures rolled up in one quality manual and they were happy to have a quality manual of about 35 pages and no procedures.Over the past 20 years, I have looked at literally hundreds of Quality Manuals from both ISO registered organizations and non-registered ones. The Manuals were from customers and suppliers and some "wannabes" in the prospective customer and supplier camps.

In the past six months, I've looked at the various samples of "minimalist" manuals posted here in the Cove.

In my opinion, some organizations are small and tight enough that it makes sense for them to include the few Procedures in the Quality Manual, mixing 1st and 2nd level documents.

Most organizations have too many Procedures to include in a hard copy manual or folks would get a hernia trying to lift it.

Those organizations seeking to attain or retain ISO registration have to produce a manual which serves their internal purposes, but which can be readily understood by a 3rd party auditor.

Many organizations consider "discretion the better part of valor" and create manuals where the 3rd party auditor can find everything in his sleep. This is the school of thought which says if you make an auditor think, he'll find some way to punish you.

Alternately, some folks have embraced the "process" concept of quality and think and depict their systems in flow charts.

The stuff in outmoded pages like endless lists of revisions (to correct typos and name new 3rd vps by name) is absolutely silly and unnecessary. Nobody except a small cadre of "authors" need to know the revision history of a document (to assure they don't invent the same wheel twice.) The document (if it is controlled) should only be available in its latest revision, making the revision history unnecessary. If it isn't controlled, why bother?

Also on my list of time wasters and tree killers are long overblown "mission statements" that sound like they were crafted by beauty pageant contestants: "We will make the world a better place with no war, hunger, hatred, disease, while striving to become the premier, world-class manufacturer of left-handed monkey wrenches."

Ultimately, the only good Quality manual is one that is understood and followed by the organization. In the past, too many "big honking ISO Quality manuals" had their best use as doorstops and ballast for the trunk of your car in icy weather. They were so expensive to print, no one ever gave copies to the employees because: "It's in the Quality Manager's locked office. If you need to refer to it, just call him up at home on Super Bowl weekend, he'll be glad to drive through ice and snow to let you into his office to read it. Of course, you will have to read it in his office while he watches, because those manuals are "controlled" and can't be let out of the office."

Heck, I can envision a one paragraph Quality Manual:
"We try to please our customers by making perfect widgets at a profit so we can stay in business. If the widgets aren't perfect, we'll try to find out how to do the job better and still make a profit. Everybody in our organization agrees to help do this. Ultimately, everything in our organization is the responsibility of the CEO and the Board of Directors, who will delegate authority to others to get the job done."

The worst trap we can put in our path is to close out eyes to something new by saying, "We always did it this way. Everybody else always does it this way."

If we followed that philosophy, we'd all still be dodging saber tooth tigers! (They wouldn't have gone extinct because humans wouldn't have hunted them to extinction with improved weapons.)

Wes,
Well said :applause:

Edited by SSwanson

The most excellent Quality/Systems manual for ISO purposes is a regurgitation of the standard with your company name substituted everywhere it says "the organization". It makes no sense to design a manual and then "shape" it to adhere to the standard. The ISO manual has one sole purpose in my mind, pass the audit with no questions and put it back in the file.

The most excellent Quality/Systems manual for non-ISO purposes is a non-existent one. Of the dozens of manuals I have read over the years, I have never seen one that was actually used by a company to make their products or services better. Overwhelmingly, they sit on a shelf or an e-file and nobody reads them unless they are being audited by a customer. Flowery mission statements and descriptions of how a company is dedicated to customer satisfaction are a hypocritical approach. Wes's one paragraph approach gets my vote.

I would be much more impressed by a company that said what they actually do, rather than what they think the customer wants to hear.

Here is what my perfect quality manual would look like:

" ."

Sorry, after 15 years in Quality I fail to see the usefulness of the rhetoric in that level of document.



Carl-

My simple opinion is the Level 1 Quality Manual does not have to be perfect to the third party auditor - it has to be good for business to the organization that uses it. If a company uses it for what it is intended for - establishing the policies for the organization (not just ISO / TS / QS / AS). Useful manuals that giude the organization into lower level documents and that can guide customer / third party to understand the system and follow the system.

Simply put it has to be good for business and make sense for the business.

As asked previsously - why go through the motions of re-writing the standards with your company name on it - make it useful. :frust:

Tom,

I hear what you are saying, but you could do a pretty good job of guiding a thid party through the system with a rudimentary flowchart. I really can't conceive of any question a customer or auditor would ask that I would choose the Quality manual as my source for an answer. I would go directly to a procedure level document to describe the processes. Even with the ISO 2000 rev. in 4.2.2 C requiring a description of the "interaction" of the processes, most manuals I have seen just give a sequence of processes and a breif definition of each. Of what use is that to the business?

If you have a manual that makes your product higher quality or increases your profits, I say go with it, but I have not seen one that would adversely affect Quality if it were thrown in the trash.

Carl-

Edited by SSwanson

Carl - I would agree with what you said. I would think that your approach would save time and money while at the same time be felxible enough for everyone to work with (understand).

I see where the standards are written they tend to point to a quality manual that covers specific issues. I would agree that these could be addressed visually (with some descriptive text in the flowchart) and it could be a far more meaningful and easier to read (follow) document.

You have given me much to think about. I would be very open to an approach like that. I am currently trying to intergrate more visuals (like flowcharts and digital pictures) into my procedures and work instructions.

I also have been working on our processes and our process maps. The logical thinking would be to apply these concepts to the Level 1 (like you have stated). Great point. :applause:

Tom,

Your points are well taken also.

Realistically, your approach is more applied because customers expect that you will maintain one. That being the case, it should be of benefit to the company as you suggest. You probably have one of the better manuals out there, most are not written with the attention you seem to give.

Carl-

SSwanson,

I certainly do not mean to imply that a Quality management system is not useful and necessary to most businesses. The Quality manual is not a very useful document in my opinion because the people that refer to it (Customer Quality managers, Third party auditors, etc.) are already familiar with how a system works and the level it is written at is vague rhetoric.

All of the questions you have suggested can be answered through the procedure level documentation.

I agree, I also take exception to those who are responsible for the design, documentation, implementation, and maintenance of the QMS on the one hand, and shirk their responsibilities on the other. I would not pay such a person, I would fire them.

It has been my experience that Quality manuals have little or no affect on a system, but as I said previously, if you have found a way to make them of great use, more power to ya!

Documentation and evidence of compliance do need to be provided, but there may be a better vehicle to accomplish this.

Carl-

To answer the question, we first have to ask why we want a QM? Is it just because the "Standard" says so?

In my opinion, the best QM would be one that is useful to the organization. The QM should outline the direction of the QMS, and give it some backbone. Looking at the requirements, it seems that was the intent of ISO.

Just one man's opinion, but for me, stating the direction of a company QMS is useless.

The fact that the company has a QMS is important.

A document that sits on the shelf and outlines the QMS as a "snapshot" in that moment of time really is wasted effort.

I have never had anyone pull out the manual and say "Hey guys, our QMS is varying from our stated manual here." Even if they did, the chances are they would just change the manual to reflect the "new" direction.

What job/purpose does it actually serve?

It is basically a document developed by upper management and the QA group to satisfy the standard or a customer, and if they don't already know the direction of the QMS, the company has WAY bigger problems than a manual is going to fix.

I have written several, used none.

Carl-

Don't hold back Wes, tell us how you really feel. :lol:

So I guess that I will be the one that thinks quality manuals and supporting documentation are necessary and can be of real value to a company.
I think that it is an art and a science to produce a document (text or flow charts) that accurately and simply documents the company's policies, objectives and processes.

I have found that most of the people in our profession are woefully inadequate when it comes to this task. In visiting countless other organizations, I have labored through many quality manuals, procedures and work instructions that could have been better written by monkeys. Why would anyone want to go to these useless tomes of verbage if they couldn't get anything out of them? What's the problem here? Did anyone ever hear of planning? Laying out your system before you start to write.

In my own career I have written entire quality systems that have been embraced by the user community soley because they provided value to them in their daily activities. When the documentation was competed it wasn't launched in a paper format. I provided online systems that were intuitive and easy to use, hyperlinked and indexed. I provided plenty of graphics, flowchart and tables.

The success of these systems was measured (subjectively) by observing the system being used and by feedback from happy users.

So IMHO, if you aren't getting anything out of your manuals and procedures then look into your management support or your own ability to put together a simple and meaningful set of documents.

Gerry,

Sounds like you have a good formula.

I did notice in your last line that you extend the subject to include procedures. I consider this a whole different animal. Procedures, in my mind, are much more detailed and useful.

Your system of hyperlinked graphics,flow charts etc. sounds interesting, however you still do not address what, specifically they are used for.

If someone asks how we perform a specific function, I can reference a procedure and give them a pretty good idea of the sequence of events, interactions etc.

If someone asks how to run a specific piece of equipment or needs a training guide, I can give them a work instruction.

But the Quality manual? It isn't a matter of how well it is written, the whole idea of it, especially in the ISO context doesn't provide any meaningful use that could not be provided in a better format.

Carl-

Gerry... Well said.

Our QM is a brochure, and the process interactions are laid out in the center. The majority of our employees found it useful because it gave them the "big picture". It helps them see that they are part of a complete system, rather than existing independently within their own process. Also, it helped them understand who gives them their information, and who is downstream.

In my opinion, if your manual serves no purpose, you just wasted an awful lot of time. Also, if it is simply a regurgitation of the standard, you have committed copyright infringement, among other things...

Note: I am not against large manuals, if they are useful to the company they are for. The name of the game is "what works for your company"... operative word is WORKS.