How do you structure the QA Manual for ISO 2000

Dudu,
You need to download a copy of ISO 10013, it will help explain quality manual developement. You can get it at http://www.ik.bme.hu - Link was: /~mohacsi/sqm/documents/10013.html

DuDu,

The easiest way I have found (I have done this 4 times) is to copy sections 1 through 8.5 of the standard, VERBATIM, then use the edit/replace function to replace all references to "the organization" with your company name. You will not be able to cut and paste from the electronic version of the standard, so someone will need to manually type the manual. After you are done this go through each section and wordsmith to fit your organization. Be careful when deleting anything. This makes it virtually impossible for a registrar to give a nonconformance for the manual not fitting the standard. Let's face it, the only reason you are writing the manual in the first place is to pass your audit and possibly send to a customer. It serves no real purpose, so make it easy on yourself. The last manual I wrote took a total of 4 hours for someone to type and about another 4 of my editing.

Good luck,

Carl-

-> copy sections 1 through 8.5 of the standard, VERBATIM,

For most companies this is fine. Many smaller companies bring their 'main' procedures into the manual its self (such as the 'required' 6). But the theory is correct. Don't over do your quality manual into a 2 month project.

Is it really that simple to make a manual like this? If that's all it takes I think I will write a new one for 9K2K. Then use a matrix to our present procedures etc.? And fill in the gaps? Am I just making it too hard?

I'll betcha that's been said here in at least 50 different threads from time to time.

Yes - it's that simple. ISO9K gives - what - 3 things you have to have. As far as your procedures, it says "...or reference to..."

Are there copyright considerations needed?

Regards
Jim

I guess they could get nasty, but since there are probably thousands of companies which have written their manuals this way, I doubt the ISO folks would take a chance at pissing off a whole lot of companies by bringing an action against one. I'll tell you what, there would be an interesting (to say the least) debate if they (the ISO folks) actually did take a company to court over copyright violations in the company's quality manual.

Just want to thank Carl and Marc for the ideas on making the QM for 9K2K. You were right on the money, took me about 4 hours to complete it. Already had it typed into Word, so that made it easy to copy and paste until I was satisfied with it. I think it will fly!

Russ...with his eyes wide open

Russ,

Good for you!

Just make sure that it doesn't "just fly", but that it is a functional document that has buy-in from all involved.

ASD...

AL-
No need to worry about that. Now that I have it roughed in I am going back over it and making sure we are doing just that. The Gap Analysis helps here, and fits right in with the matrix to the procedures. I guess now the biggest job I have is extracting the few procedures that have been included in the QM that didn't need to be there. I need them, but in the procedure section not in the QM.

Russ...starting to see the light!

Could you come back to me on this one, as it all seems to good to be true. Just to check my understanding, how would you rewrite for example section 7.5.2 Identification and Traceability.

The organization shall identify, where appropiate, the product by suitable means throughout production and service operations.

The organisation shall identify the status of the product with respect to measurement and monitoring requirements.

The organization shall control and record the unique identification of the prodctt where traceability is a requirement.


Just interested to see a real life example. Could you add an example of a reference to a process.

Regards


------------------
Andy B

This is from an audit a month ago. This does not relieve you from having to be ready to explain everything.... In this case they probably should have referenced their design process map in 7.5.2. Oops!

*****************

7.5 Production and service provision

7.5.1 Control of production and service provision
As applicable, the organization plans and carries out production and service provisions under controlled conditions. Controlled conditions include:

a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement activities, and
f) the implementation of product release, delivery and post-delivery activities.

Supporting Documentation:
Production Control Map
Process Control Map
Delivery Map
Equipment Maintenance Map
Nonconformance Control Map
Quality Control Map
Product Identification Map
Product Handling and Storage Map
Technical Service Map

7.5.2 Validation of processes for production and service provision
The organization validates any processes for production and service provisions where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. As applicable, the organization establishes arrangements for these processes including:

a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

7.5.3 Identification and traceability
Where appropriate, the organization identifies the product by suitable means throughout product realization. The organization identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization controls and records the unique identification of the product (4.2.4).

Supporting Documentation:
Quality Control Map
Delivery Map

[This message has been edited by Marc Smith (edited 01 August 2001).]

Do you really need Supporting Documentation: after each section when you point to a procedure matrix that connects everything? Where should I reference this matrix? I have it referenced in 4.2.2 now, should I reference it in all sections?

Russ

Well, ISO 9001:2000 states:

4.2.2 Quality Manual
Also see: 4.2.1b

The company shall establish and maintain a quality manual that includes

a) The scope of the quality management system, including details of and justification for any exclusions (see 1.2),

The scope is very important. This scope defined here will be matched against the scope of your registration. Do note that should you plan an exclusion from section 7 you will have to give a documented explanation (reason) rather than a verbal explanation.

b) The documented procedures established for the quality management system, or reference to them, and

Technically by saying "…or reference to them…" this almost allows you to have an index of your procedures with a scope statement. In the strictest sense of the words here - you explicitly have to have reference to your procedures. To comply you simply make a matrix, if you have one, part of the quality manual.

c) A description of the interaction between the processes of the quality management system.

Line item ‘c’ can best be illustrated through Flow Charts. This is discussed in more detail in 4.1 herein. Key word: Interaction. The above is just how one client did it. They also had a matrix, but the linkage was desired within the manual. Technically yes - the above is redundant since they also had a matrix. If there was no matrix I'd be worrying.

[This message has been edited by Marc Smith (edited 01 August 2001).]

I am still hesitating a little before taking this route. A verbatim copy of the ISO 9000 standard does not tell an auditor how the company is complying with the standard. My guess is that this will have to be added in some way, in which case you end up writing a complete Quality Manual, and inevitably doubling up on the content that exists in the Processes and Work Instructions.

I also note various comments strongly promoting that all staff are well trained on the contents of the Manual. As i see a Quality Manual as not providing ANY value add (I am not talking about the Processes etc that CAN add value to a companies operation) i was desperately trying to avoid this potentially demotivating training erxercise.

I have always followed the concept that company employees should know very well their own processes, but do not need to be overburdened with ISO 9000 details, it should be enough if just one person in the company is translating the needs of ISO 9000 into the company processes.

Thanks for input so far



------------------
Andy B

-> I am still hesitating a little before taking this route.
-> A verbatim copy of the ISO 9000 standard does not tell an
-> auditor how the company is complying with the standard.

Nope - it's not. Your procedures do that.

-> My guess is that this will have to be added in some way,

Nope - not really, see the following...

-> it should be enough if just one person in the company is
-> translating the needs of ISO 9000 into the company
-> processes.

That's the idea. That person explains to the auditor how everything fits together. If you want to fluff up a quality manual and sink days or weeks working on it or something - be my guest. I'm just pointing out the baseline.

-> My guess is that this will have to be added in some way,
-> in which case you end up writing a complete Quality
-> Manual, and inevitably doubling up on the content that
-> exists in the Processes and Work Instructions.

As I said, your procedures provide the detail (to me when I say procedure I 'mean' flow chart(s), of course!) You're over complicating this. Now you're bringing in work instructions!

-> I also note various comments strongly promoting that all
-> staff are well trained on the contents of the Manual.

Only parts that apply to them. But what does apply to them they must know - including understanding what the words mean. Just as they have to know and understand local (departmental) procedures which affect them. The same as the fact that they have to know and understand the corporate sexual harassment policy.

As far as ISO 'training' for everyone, I do beileve an ISO awareness training 'presentation' is a good idea early in implementation. Just the basics. After that, new hires should get the awareness presentation during orientation. 15 to 30 minutes of the basics.

Andy, it sounds to me like you're seriously over-complicating things.

-> As i see a Quality Manual as not providing ANY value

Which is precisely why you want to keep the 'quality' manual simple. It's just a skeleton to hang things on.

-> I have always followed the concept that company employees
-> should know very well their own processes, but do not
-> need to be overburdened with ISO 9000 details

Exactly right. If it doesn't affect them, it's none of their business.

OK Marc, point taken.

Just as a matter of interest, do you ever get involved yourself in writing the Quality manuals? Do you strictly avoid this, or does it depend on the capability of the company?

Regards

------------------
Andy B

[This message has been edited by Andy Bassett (edited 03 August 2001).]

I try to pressure the company to do it. They almost always do. It's really pretty simple. One key is to not try to write your quality manual and then write procedures to fit it. Start with a matrix and document mapping with consideration to your gap analysis results. Have the main body of the manual (the ISO text) set up and ready. As your matrix fills out, you go to the appropriate section of your manual and insert the appropriate reference. Again, I admit this is redundant because technically you have the matrix.

<FONT COLOR="#FF0000">A word of serious caution here</FONT>

Many companies do insert some additional details in their quality manuals. In fact, some companies have all the relevant level 2 'procedures' in their quality manual. The folks I worked with last winter did exactly this. They inserted flow charts in the MS Word document which was their 'systems manual' (as opposed to calling it a 'quality' manual) in the 'appropriate' sections of their manual. It was still relatively short - maybe 50 pages - and just about everything was there. Departments controlled their own work instructions and such, but for all intents and purposes the main systems are defined entirely within their systems manual.

When I work with a client I often do, in fact, suggest clarification statements here and there throughout the manual.

Look at how your system is structured (including corporate, if you're in a big company - they have many documents which apply to your location {and other locations}, I would bet). Ask yourself what you need in your manual. But - don't go overboard. Don't complicate issues and <FONT COLOR="#FF0000">Don't be redundant!</FONT>

I attended a meeting yesterday of regional quality professionals and one of the ISO Registrars said the following question was raised at a session he attended in Cleveland, OH recently.

"Are we ready to accept (1) page Quality Manuals?"

Any comments???

I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion). that said, obviously it is easier to audit to, especially for doc review...but then I never was one to take the easy road.

One Page?
Why not!
What's the problem with that?

------------------

Originally posted by barb butrym:

I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion). A 'quality manual' is bunk. I totally disagree that "...its shallow and meaningless...". Please, please tell me. What do you expect of a 'quality' manual? Why is it important beyond serving as a skeleton to hang things on?

I personally look for a brief, 'by the book' manual "...with references...". The references are where the meat is.

When I see a manual which is little more than a repeat of the standard, I see a company which realizes the limited significance of a quality manual to begin with. I see a company which doesn't waste time and money on bull. I remember the arguement from years ago. It was the old "...make your quality manual special. Make it YOUR manual, not just a document you have because of an ISO requirement...." That was bunk then and it's bunk now. I've seen companies spend months and thousands of dollars on a 'manual' which should take no more than a day or two to 'tailor' and put refernces in. Now THAT is crazy, if not simply stupid.

A one page manual? Yup - I'm for it. But - as I have stated in numerous threads in these forums over the years, I stick with the 'copy of the standard' version to avoid 'missing something' which may just be a word or two. I first saw that happen in 1994 and have never let it happen again.

One page manuals? If the system is correctly structured and procedures are appropriately written to address requirements - not a problem. I'd go with a simple matrix referencing the ISO paragraph (requirement) to the appropriate company procedure.

Unfortunately, excessive, overly complex documentation is the 'norm' when companies undertake ISO. They don't know 'when to stop'. That's specifically why many of the changes from the 1994 version address documentation requirements.

One page has my vote. I propose a 7 or 8 point font.

[This message has been edited by Marc Smith (edited 22 August 2001).]

I should have said that I support the theory of a one page manual. My reality has been that by the time you kick in a matrix, a flowchart, introductory and marketing-type statements (for customers who request a copy of your QManual with tenders), then referencing policies and procedures it ends up more like 7 or 8 pages.

This excludes all the traditional standard re-written stuff. So I'd have to use about a 2 point font!



------------------

The idea of a 1 page Quality Manual is probably an exaggeration. I raise the question in this forum because I am interested in developing a FIRST TIME Quality Management System for our company that is VERY, VERY SIMPLIFIED, easily understood and maintained.

What I really want to do is start with ONLY what's required by ISO 9001:2000 and ONLY add to it as required by other statutory and regulatory agencies. I want to use charts as much as possible and keep the amount of documentation to a minimum.

Over time, as people become more "quality literate", then we can build on the basic framework without over complicating or losing sight of the core requirements.

I would be very interested in hearing from anyone that has taken, or considered this approach. (Especially the use of flowcharts to replace text procedures).

A "small" QM was discussed 3 weeks ago in http://Elsmar.com/ubb/Forum15/HTML/000303.html
and I repeat some my words: ".. it was last July in Kyoto during ISO/TC 176 meeting. It was an Open Forum and we discussed one ( among all others) suggestion “Is it a real need in documented Quality Manual”? The answer was “yes”, but the descending importance of QM became clear."
As for registrars: their real interest in QM is in OrgChart ( to prepare an Audit Plan) and in Procedures Matrix ( to define a scope of Adequacy Audit). I understand them. Many QMs look like "brothers and sisters".
As for Sales: I think that an illustrative, not tiresome Quality Comics, written in a friendly easy manner is more attractive than an ordinary QM. Does your client really want to know what do you do with "identification and traceability"?
I hope we'll see in future such pleasant QMs. They should provoke staff to read other Quality documents. ISO 9000 isn't an amusing book. Let us do it so.

I skimmed the forum and don't think I'm repeating much here.

What happened to the philosophy that a Quality Manual is a 'roadmap' for the organization? I know that the first thing any registrar does (at least those that I've dealt with) is to use the Quality Manual to get a sense of how we operate and what procedures we have to cover our processes. We also refer to it fairly often internally to communicate and re-enforce the 'right' way.

And I know Quality Manuals are used as a sales tool. We've requested them from suppliers as part of the qualification process and had ours requested (especially internationally) as part of the contract-letting process.

I know we may be talking from two entirely different perspectives but I want to recognize the value of the document beyond what's required for registration.

Alf

Originally posted by ikar

A "small" QM was discussed 3 weeks ago...
In these new forums, in case you want to continue the thread, the thread is at:

http://Elsmar.com/Forums/showthread.php?t=2694

> What happened to the philosophy that a Quality Manual is a
> 'roadmap' for the organization?

Well, there are a lot of interpretations of just what a quality manual is. That is a valid interpretation. But so many different companies and so many different industries make it a moot issue. The question becomes a matter of over all content - not how you deliver it. Quality manuals were, years ago, rare and there was a quality manual 'philosophy' at the time but I don't think there is any more.

The same effect, so to speak, can be seen in procedures. I remember back in 1995-6 when I set up a company with all level 2's in flow charts. The auditors came in and freaked out. I can still remember the guy saying "...These aren't procedures!..." The auditor's paradigm was the old rigid, text format. In fact, there was recently an interesting thread in the ISO ListServe I may copy here about documentation. Question: What must a procedure contain? A header? A footer? Revision level (what if we do revision by date instead of by 'level')? Authored by? Revised by? Revision date? Distribution list? Do you have to have a hard copy with an ink signature?

All these questions I could appreciate as I broke my 'quality' teeth in military manufacturing before personal computers were on every desk. There was a very structured, expected format for procedures. Most companies had, for all intents and purposes, similar procedures (at lease those involved in military manufacturing). Back in those days every company of any size had a specific department where all they did was type, distribute, retrieve obsolete and control procedures. Personal computers have changed all that.

Documentation has evolved significantly in the last 20 years. I'm sure some will stick with a 'quality manual philosophy'. When I work with a client I'm concerned about total, overall content. What is where. Is everything present and accounted for? This is the main reason I push every client to have a cross-reference (matrix) where they track the requirements (in this case ISO) line item by line item to the document in their system which fulfills the requirement. For me it's a simple issue as, when you look closely, if you're just starting this is called a Gap Analysis. A detailed Gap Analysis I must admit - not just a 'Does the system Exist?' Gap Analysis. But this is the way I start and track an implementation. Call it a Gap Analysis. Call it a Check List. Call it what ever you want. I can say auditors love them and they make audits a snap. They reduce confusion. They ask how you comply with section X, paragraph Y, letter A you just look at the matrix and go right to where that line item is addressed within the company's doumentation system.

That said, the two ISO 9001:2000 audits I have gone through have differed from the 'old days'. There were the same issues of "...show me where you address this..." but in addition continuous improvement and such were discussed more and in length. In large part, in my opinion, it almost approached consulting - which I discussed in another thread. In my opinion most of it is more verbal gymnastics. In my opinion it does not diminish the value of a cross-reference matrix.

Back to the Quality manual issue... Look at how your over all documentation system(s) are structured and decide what is right for your company. I have had smaller companies where their level 2's were all part of their quality manual - and all were flow charts. It was right for them, their size, their company. It would not work for many companies but for this one it did.

I think the structured quality manual idea, including having an ISO 'guideline' on quality manuals, is a fine and dandy idea. I'm also happy it's a guideline and not a requirement. Do what's right for your company and your internal systems.

Philosophy..... I remember taking a course or two with a name like that whilst in college back in the early 1970's.... :cool:

You have mentioned that copy verbatim of the clauses 1 to 8.5 of the standard. If I not mistaken does it refer to ISO 10013 or any other standard

Can you please clarify.

I also would request viewers to post a model manual compliant to ISO 9000:2000 to post in this site. for different companies viz. manufacturing, software, hospital, service, textiles etc

It is not fair that the quality manual will have verbatim all clauses from 1 to 8.5. This means that it is done for the sake of compliance to ISO 9000:2000 and not in true spirit of ISO.

The clauses give a guidelines as to what it means. One can rephrase it to include the necessary details to comply with the clause. This will make ir more meaningful.

The reader foer example the auditor will be interested to go through the clause and put his head into it.

This will serve much better and not verbatim copying the text given in the standard

However I dont criticise those who do so. This is purely my personal views

I challange anyone to attach a copy of a quality manual which does not follow ISO 9001.

Now - you speak about 're-wording' the manual and saying that's OK. I see no difference. If you want to take the manual and 're-word' it what are you doing? You're taking the ISO text and putting in some 'personalization' - which is typical to some degree anyway.

Take a look at the 'Quality' Manual posted here:

http://Elsmar.com/pdf_files/ look for ISO9k2k_Low_Vol_Manual.pdf

It is nothing more than a regurgitation of the text and accomplishes what is necessary.

> This means that it is done for the sake of compliance to
> ISO 9000:2000 and not in true spirit of ISO.

Please define what the "...true spirit of ISO..." is and explain how this manual violates that 'spirit'.

What I want to convey is that the organisation going in for certification should do with sincerity and for the sake of complying to it. This is what I meant 'true spirit of ISO". Today even if a single page of a book is reproduced the publisher sues the author of the book for volation.

It is with this intention that I mentioned.

The motive is "not to get into unnecessary hazzles"

Forgive the uneducated question, but my background is in QS and TS......
What is the difference between ISO 9001 and 9004? I'm looking to purchase the manual through ASQ, but want to make sure I'm going to end up with the right thing. Are they actually the same standard now?

9004:2000 is the Guidelines used to comply with 9001:2000. It is actually called Guidelines for Perfomance Improvements. Go for it.
You may want to purchase 9000:2000-Fundamentals & Vocabulary. Then you have the three main ones.

I will recommend the 'combo-pack' purchase option of the following for Quality Management Systems:
Q9000-2000 Fundamentals and vocabulary
Q9001-2000 Requirements
and
Q9004-2000 Guidelines for performance improvements

The 9004 is also helpful because (IMHO) it provides a 'heads-up' to what 'possible' improvments that may be added to the 9001 Requirements on the next review/revision. At least identifies current trends for long term focus. Did I say that clearly? Hope all know what I mean.

PS: Okay, I see 'energy' went in and updated his post to include the vocabulary sections too. Hmmmm...didn't see a 'Last edited' note...must be those advanced features moderators have huh? lol ;)

E. Wall,

I noticed you were on line at the same time. I just answered quicker.

Then that is really strange....or maybe I'm coming down with something? maybe selective vision? heheehe, I would swear that your message ended with the 'Go for it' and it was only after I finished my post that I saw the second referal about the vocab book. Sorry for any confusion, was only trying to tease.

> didn't see a 'Last edited' note...

This is part of the new software 'features'. I can set a time limit during which you can edit your post before it starts adding the 'edited by x at y' tag line. I think I have it set for 10 or 15 minutes. I know a lot of times I submit a post and see spelling errors (not being smart enough to use the 'Preview Post' feature). Or I want to add something or change something. I then go in and edit it right away. But - if I wait more than 15 minutes (or whatever I set it at - I forget off hand) it will start adding the 'edited by x at y' tag line.

E.Wall,

You are correct. I had an after thought and went right back in to edit and add the last . You aren't imagining things. As Marc has said, I was under 5 minutes to do the editing. You must be one heck of an auditor. Eyes like chicken hawk. I also will do it when I notice a misspelling or obvious grammar error. Don't want to look too ridiculous. This message was edited twice and you won't see an edit note. Later.

Glad it wasn't my imaganings! :P
I most always get the edit note...if I haven't I don't realize it. But then I'm always getting interupted when at my desk...not to mention long winded :) so I guess I'm exceeding the 'grace' period.

Well I have some changes to get finished to my RCA program...sometimes I feel like I'm writing for 5th graders the way EVERYTHING needs to be spelled out...but anything open to interpretation seems to be challenged, so I'm updating the process...again!

hhehee, chicken hawk...I like that, I'll have to search through the avatars...wasnt' there a chicken-hawk on the Foghorn Leghorn cartoons?

I think when you go in and edit a post you've been 'working on' within the allotted time period, the timer resets for another 15 minutes or whatever time is set in the admin options when you submit the edited version.

Yup - Foghorn Leghorn (the rooster) is always being 'bothered' by the little chicken hawk.

But - back to Quality Manual issues!

At times two persons can convey the same issues. One cant generalise that it was copied from the other.

If edit option is available after post this is possible.

I dont think this is an issue.

Let's discuss about quality, quality, quality - it can be applicable to any type of organisation.

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please

Originally posted by venkat

I see very few post pertaining to US FDA approvals. What type of documentation one should prepare if a pharmaceutical company go in for US FDA approvals. The sequence of sgteps involved

Your views please

Well, there is an FDA related forum where you might want to start a new thread on this topic. That forums is at: http://Elsmar.com/Forums/forumdisplay.php?forumid=44

You'll have to go back at least 100 days to see any posts. The forum isn't very active.

Actually that would be Canadian pennies so I should really put 4 in for the exchange.

I was chatting with our registrar earlier in the week about changing our manual over to 9000:2000.

What he told me was (& I am not sure if anyone else has said this already)...look at our process, from start to finish & create main headings (Selling the product/service, then what is the next step, then the next step, forward to design/engineering, forward design to the shop floor, etc, etc, etc)

Each of these main headings is a procedure, and each step to that main heading is a point to be detailed in that procedure (be it in the procedure or reference to work instructions).

When these are complete compare it to the requirements of the standard. If you are missing any information from the standard plug it in where it belongs.

Anything that doesn't fit into one of the main heading for your business process gets placed under Management Responsibility (including Internal audits, Management Review meetings, etc.).

What the auditor told me was that "Yes it makes them work a little harder to find the information (but in MHO that is what they are being paid for), but it follows the way product/service flows through the company.

I hope this makes sense to everyone...if anyone would like to email me to discuss this more, please do (our email is hit & miss sometimes, but I will respond ASAP). I am figuring that this will take me about 1 - 2 weeks to complete (walking through the process, discussing ith staff & departments & writing the procedures).

I Would love to hear everyones opinion.

thanks tim

"...if it moves, train it...if it doesn't move, calibrate it...if it isn't written down, it never happened..."

If it works for you, do it that way. I see no problem with that methodology except how much time you want to put into it.

Also see this thread:

http://Elsmar.com/Forums/showthread.php?t=4866

DuDu,

The easiest way I have found (I have done this 4 times) is to copy sections 1 through 8.5 of the standard, VERBATIM, then use the edit/replace function to replace all references to "the organization" with your company name. You will not be able to cut and paste from the electronic version of the standard, so someone will need to manually type the manual. After you are done this go through each section and wordsmith to fit your organization. Be careful when deleting anything. This makes it virtually impossible for a registrar to give a nonconformance for the manual not fitting the standard. Let's face it, the only reason you are writing the manual in the first place is to pass your audit and possibly send to a customer. It serves no real purpose, so make it easy on yourself. The last manual I wrote took a total of 4 hours for someone to type and about another 4 of my editing.

Good luck,

Carl-
:eek:
This is from waaaay back ( 12th July 2001) but when I read it I had to bring it to the attention of the current audience. If everyone did as Carl has suggested above why would we need a quality manual??? Couldn't the registrar or customer change our name to fit the 'organisation' in the standard therfore relieving us of the need to write a manual (just to waste paper)??? I have had manuals that were ....almost...verbatim from the standard but nothing like Carl's description. My new manual - in development (again) will be a story of our company, products and methodology for our customers and employees. All of our new employees and customers will recieve a copy. I hope to finish the manual in the next few weeks. It will have many process and flow charts . I was going to have only charts but decided that it needed a little more explanation.

Greg B

That was just the way you had to do it back a while in large part to satisfy auditors.

Things have seriously changed, eh?

I almost had my sanctimonious hat on! I saw the thread on "Definitive discussion on QM" come up and started reading some of the drivel about turning the standard on its head and thought it was current! Thank goodness nobody on the cove is encouraging that any more.

Naw - I 'brought the thread' to the front because it shows how things have changed. BUT - At one time it WAS one of the 'Definitive' threads on quality manuals!

You can take the hat off and sit back.

Naw - I 'brought the thread' to the front because it shows how things have changed. BUT - At one time it WAS one of the 'Definitive' threads on quality manuals!
Still appears to be very valid now.

I have painful memories of massive manuals that were spread around like confetti to certification boards, customers, staff and anyone else who wanted it. Plus the procedures Work Instructions etc.

Now I have a 'signpost' into the real heart of our system.

Oh and by the way, its not a quality manual, but a Management Systems Manual.

I did this many years ago and was given a non-conformance (major) because it was not titled 'Quality'

Ahh, how the auditors change...........