As I have made no bones about, I see a Quality Manual (which I prefer to call a Systems Manual) as a regurgitation of the standard with some 'company specific comments' and references to the fulfilling company procedures.

I have seen many write about 'making the quality manual yours' and such. I'm not sure I've seen such a manual in many years. Thus - the reason for the Poll.

Comments in replies are welcomed, but please take a minute and 'Vote' in the poll, too. Thanks!

EDIT ADD: Just to clarify things, when I started this thread it was 2001 - It was at the end of the days when auditors said "Show me where you address this in your quality manual and procedures." In the 'good old days' you would earn yourself a writeup if something was not addressed within the manual even if you did not do that (by exclusion or whatever).

It is now 2004 so many things have changed, one of which is quality manual content expectations. Thus, my initial comment above is no longer is 'true'.

Marc - for our 9002;1994 version "Q manual" - 1st draft we began by using our own numbering system... Our outside consultant - advized against this - because it would "tend to confuse external auditors" and they don't like to L :eek::eek: K around" for what they want to see ...

It really made no difference to us what the numbers were - and after 3 years - probably the ISO rep and lead auditor are the only ones that can list them or toss out a number in a conversation and understand what they were talking about anyway - without looking at an index.

It was the section and procedure titles that we felt important..
Every section that we intended to "make our own" in the 'Q Policy tier 1 manual.. was challenged by our external regestrar folks anyway...

Each change was made as they requested with the 'Improvement comment" - Manual can be clarified by aligning section to - (word for word) standards language.

We found that the effort/opportunity to "taylor" documentation to our actions was left for tier 2 "procedures manual"

Aack - Marc, I hate ones that are a regurgitation of the standard. The first one I wrote was in company language, although I did give it 20 sections. I used paragraph forms, addressing all the requirements inserting procedure references as necessary. I do not know if it still exists that way. I think much of the regurigitated statements should be covered in procedures. I also dislike 'canned' ones - maybe because that's how they look.


They definately make auditing easier for the auditor, but whose manual is it - the auditor or the company? I also think the new standard helps the company write "their manual" - defining their processes, and again references to procedures as appropriate.

Regurgitations are easier, but I just don't like 'em.

I agree with Marc most tier 1 QMs are a spit back of the standard subing your company name and adding the reference to the tier 2 System procedures. 4.1 and 4.2 is where you add a little detail. I think the new standard reconized this and most companies will reduce the Number of pages in the QM. Save a tree and disk space

I have such a regurgitated manual for ISO 9K2K and I did run into my registrar wanting some detail for 4.2.2 c which I am working on satisfying with a flow chart. However he flatly refused to entertain the thought of incorporating our QS requirements in with the new QM. I have to cover both ISO 9K2K & QS9000 but I see no way to do it without a double QM. ANy suggestions while I wait on clarification from my registrar?:eek:

A double set of manuals is silly, IMHO. I cannot guess why the registrar would 'flatly refuse' a single manual.

I agree, double manuals just don't make sense. While I am a firm believer that we should listen to our registrars and use their knowledge to drive improvement within our systems, I just cannot find a way to justify what they are telling you? Where is the added value in maintaining two sets of books? ...in some circles that would be considered illegal;) oops, my sarcasm is running high today :)

There comes a time (or several) in every quality manager's career when he must stand up to the registrar and say "that's just not right!" This may be one of those times for you. What is the worst thing that can happen? If they won't work with you, find someone who will. Not a perfect solution, but you are the customer in this case, and it is their job to satisfy your needs.

Have a good one!

Our QM is not an actual document, but an Intranet Site.

There is no actual numbering, but it is structured around the work that we do, our products. The intranet site provides the L1 documentation, with a cross reference section showing the mapping to IsO9K:2K, as well as background information on our functions. It is designed so that the user can drill down, getting more and more information as required, until they reach the flowchart of the specific procedure (there are also quick links to get you straight to the flow chart).

The intranet site also provides a one stop shop for quick access to the Documents database, the CAR database, and the IA system, as well as all the operational databases and systems.

Yes it is more work for the auditors, and for me convincing them that everything is covered, but it makes much more sence to the people who actually have to use it day to day.

Here is what I did with my quality manual:

1) first I copied the entire standard from clause 1 through 8.
2) then I inserted references to our existing tier 2 procedures and inserted our company name in all the right places.
3) even though it is not required, I created a flow chart that displayed our business (engineering services) processes from getting contracts in the front to delivering products at the end. Within each block of the PMT (process mapping tree) I placed a referrence number to the 9001:2000 standard and the corresponding tier 2 procedure(s). When completed, the PMT shows how my company does business through 7 core processes ... not how the standard is layed out. (I can look at a copy of the standard if I want to see that.)
4) Then I cut and pasted and rearranged the entire quality manual to realign each section with my PMT instead of the standard clauses. The section numbers in the manual now match those 7 core processes shown in the PMT. I did leave a reference number in each section that points to the appropriate clause of the standard for those inquisitive employees and auditors.
5) Last I created a cross-reference matrix just for the external auditors to use to find their way around.

What I am left with is a quality manual that clearly is aligned with the daily business processes performed by the employees ... not aligned with the ISO standard in a clause by clause sequence.

I wanted to make our QMS transparent to the employees as they performed their daily tasks so in some sence they could follow the QMS without a whole lot of trouble. Aligning the manual with the standard only makes it easy on the auditor, not those who use the system on a day in and day out basis. My manual meets the stated requirements of 4.2.2 ... so I'm not worried about any surveillance audits.

If the standard is truely all about process, customer satisfaction and improvement then getting the employees to "buy-in" and embrace the QMS as part of their daily routine is my overall objective ... not making it easy on an auditor who only uses our QMS twice a year.

I writing a quality manual for a consulting company...they are very small and only consult to the food industry..(fresh produce consulting to be exact) and I was curious if anyone has written a Quality Manual for a strickly consulting only business....I am trying to keep this as simple as possible....This would probably entale eliminating all of section seven?...or maybe just keeping the 7.5.1, 7.5.2 Service provision items...no production provision....I could probably get this whole manual into several pages and the make the OPS just a couple all inclusive documents...?

Marc..I know you are a consultant....are you ISO registered...? if so did you keep it as simple as possible?

Any help would be greatly appreciated....
As always this site seems to keep providing great insight into some cloudy areas!!!

Thanks
Chris S.
Wisconsin:D :D

Another manual I am working on took a 5 step form rather than the so called eight...since their is really only 5 meaty sections of the manaul...Product Real, Resource Mgmt., Mgmt Responsibility, Meaurement, Quality systems.... I may be wrong...but I keep very similiar to the standard sans the 1st three sections being consolidated into the Introduction part of the Manual.

As always...enjoy the sight and its information.:D :D :D

Chris. S

Marc,

In my recent last full time employed position (now working on Client contracts under my own Company) as a Quality Manager within a large Global ICT Company we had a Country-Wide 'Company-Wide' ISO 9001 (1994) Registration (All services all support functions --Admin, Finance, HR etc within the single Country).

The Business Management System was Intranet Web-based.

There was NO Quality manual as such!
The Intranet- published- BMS comprised of a Navigation menu system to Policies/Processes/Procedures/proformas/ref info/supplier lists/performance stats.

When asked by Customers for a copy of Quality Manual we explained we did not have one/asked what they wanted to gain from it and either invited them to view the BMS or supplied the odd policy they were interested in hard copy.


-- I suppose you could say the whole intranet web site was the Quality Manual, containing all the policies processes and procedures as opposed to a Quality Manual containing Policies and referencing to the Processes and Procedures.

Long ago the day when one had a BSI 'Stamped as approved' hard copy Quality Manual.

Best Regards

Brian H

Wonder if other forum Members adopt same 'NO Quality Manual approach (makes life easier) with their Web-based BMS's----- do I see another poll emerging on this one?

As a matter of fact, I have seen the same thing. The policy statement, followed by a flow chart (Level 2) followed by links to referenced instructions. Worked well for the particular company because they were fairly hi-tech, building complex machines, - so everyone was computer literate.

I have a client that went to a server system, and as I re-do for Y2k, I'm thinking of integrating the documents more.

My last 2000 implementation client did something like that. They started out with a 'skeleton'. I forget what all they had, but all functional areas and it was like a tree. Everything was an active link. Even at the system flow chart level - the listing of associated forms and related procedures, etc. were right on the flow chart and they, as well, were active links to the forms. Some forms were pdf files and some were links to a database interface (front end). They technically did have a 'quality systems manual', and it was online as well in pdf with references as active links. They did a real nice job.

That's the future for most companies. I'm working on an 'upgrade' - a client I helped back in '97 in their implementation. They had 14 employees then and 1 computer. They now only have 13 employees but have 14 computers. They're moving everything 'online'. So - even small companies are doing this.

When I worked with Motorola everything was intranet-internet -- available world-wide. But they did have a 'quality systems manual' as well. Online, but they had one. Well, there were many, actually - facility level, sector level, etc.

So.... Thinking back, I believe every one of them did have an actual manual.

I agree with Marc. Most QM's I have seen are cookie cutters of the standard themself. 9000:2000 attempts to make things a little more indepth. Currently, I'm locked in a struggle with our 3rd party auditor. He believes that the QM should be an integral part of your 2000 system, that outlines your processes, etc. I agree it does it to a point, but level 2's get you into the "nitty-gritty" of how things are done, who's responsible, etc.

What the 'new' standard does is confuses issues which were formerly well categorized and made this confusing document wherein there are more back and forth references than you can shake a stick at. And don't start me on the topic of 'subjective'.

The more I get into this the more I dislike it. It almost reminds me of moving from written tests to oral exams in college. There's a whole lot more explaining to do than before and a whole lot more 'interpretation'.

This great emphasis on a quality manual is down right silly. Who are these consultants and auditors who want to tell you where and how to define your systems?

I also dislike the Customer Satisfaction and Continuous Improvement BS. You can't mandate these things in part because they're naturally occurring anyway. How else do companies stay in business? Not to mention Customer Satisfaction, like Continuous Improvement, is relative.

Marc,

In the words of Sharon Stone:

YES. YES. YES.


Or Billy Crystal:

"Don't get me started on that!"

This is part of the reason the FDA and many 'regulated' medical device organizations are walking away from ISO 9001:2000 and getting ready to get registered to ISO 13485:200x. Not only are Customer Satisfaction and Continual Improvement ridiculously subjective, they're no-one elses' business. As Marc suggests, if a company fails in either area they're toast anyway.

Another reason for going down the ISO 13485 path is that ISO 9001 is expected to continue veering off in this unfortunate direction whereas ISO 13485 is expected to stay on course.

Alf

Please, Alf - start a new thread on ISO 13485 (we've gotten a bit off topic here me thinks) and tell us a bit about it. I know nothing about it. Maybe I should buy it and find out what I'm missing out on here.

Sorry, Marc.

I wasn't trying to de-rail this discussion - just adding something that I thought was connected.

My apologies. I'll see if I can figure out how threads are started and do that in the FDA slot (actually, I think I recall one there somewhere already).

Alf

Going off topic is not a big thing around here as you know (it's one of my personal specialities...) - I really AM interested in ISO 13485 and thought a dedicated thread would be a good idea. I may be wrong - it may be relevant to this thread. Nothing to be sorry about. I apologise if was 'stern' sounding.

BTW - to start a New Topic (Thread) just go the the appropriate forum and click the Start New Topic button.

Oops! The thread ISO 13485 is discussed in is History and Current Status of ISO 13485 (http://Elsmar.com/Forums/showthread.php?t=3259) Sorry for my ignorance.

People,

As a 3rd party auditor please stop giving me the regurgitation of the manual.

I konw you dont meam\n it.

One of my favorite manual contain 60 linked flowchart - that's it.

Another is a 600 person project managment group whose total manual is about 30 pages. The rest of the system resides in a system called formware. These are forms that require certain valid inputs before a process can end or begin. All the deliverables from a process are defined. The whole system conains not one word of ISO speak

Originally posted by John The Auditor

One of my favorite manual contain 60 linked flowchart - that's it.I don't think that the issue is that simple, but I agree with you. The problem generally lies in that companies that have been in existence for a while already have procedures in place. In addition, my ISO 900x experiences - dating back over 10 years - is that many auditors will be going through the documentation and say "Well, what about line item x? Specifically where does it say that in your supporting procedure?" To me it was, early on, enough auditor bull - give the auditor something simple enough that everything is there and directly points the auditor to the appropriate documentation. And don't miss even 1 line item. I have since prepared my clients for, and expect (sorry :( ) a really stupid or pricky auditor. If we 'get a good one' - all the better. If we get a 'picky' one we're prepared.

I can't remember if it was in a thread here or in the ISO ListServe *** DEAD LINK REMOVED *** but there was a good discussion on whether you even need a quality manual. There was some good back and forth. I personally 'require' clients to have a quality manual because they are so simple to do and they serve as a directory - pointers if you will - to fulfillment of the requirements.

It also may be that you know what you're doing. The 'Call for Auditors' has brought every known type of soul out of the woodwork and into auditing. Just as it has in consulting, I will add, being a consultant. Everyone seems to have taken early retirement and is now an auditor or consultant. I have run into some of the stupidest auditors that the world has ever seen. Many (most?) simply do not accept the 'outline' idea.

A quality manual is so easy to do - and for most 'starters' ties everything together that I've never seen it as an issue. I'm in the middle of my third and 4th update to the 2000 version and have a simple, fill in the blanks manual. Take old manual, bring the pointers over. Check old manual for additions (they all have modifications to some degree specific to the company) and bring them over. A morning's job if you stick to it.

Do I agree with you? Yes. But I bet that to the largest % of auditors that would be like waving a red flag in front a bull. In part I say this because I went through something similar (auditor ignorance) with flow charts in 1995. The auditors came in and it took close to an hour of negotiations before the auditors would conceed that flow charts are, in fact, procedures. It was the first company that I did all the level IIs in flow charts. The auditors had never seen such a thing! Though converted and dated in1996, if you take a look at these old flow charts (http://Elsmar.com/pdf_files/flowcharts/) you can see some the originals. They have been posted there (here?) - free - for almost 6 years now to give people ideas about how to approach simplifying documentation.

This last June I finished up with a client who had everything on the intranet in chart fashion. It was really neat. Started with a top level 'company' flow chart - sorta like a tree and all the sub-processes were branches. Everythig was interlinked. No - no Mickeysoft bull and bugs - just a cheapie program (which is really, really nice, called SmartDraw). Systems flow charts were so linked that - click on a 'referenced Form' and it would open right up. I originally argued against it and its complexity, but they over ruled me and did it - and did one heck of a job. I still think they over did it, but it really is nice.

Again - I agree with you, but reality aften smacks us in the face when we're not prepared. I just wish I could remember where that thread on whether or not you need a quality manual is. If I run into it I'll come back to this thread and post the link.

> The whole system conains not one word of ISO speak

The only 'Iso Speak' is in the quality manual its self. Limiting it to that space can do wonders.

> Another is a 600 person project managment group whose
> total manual is about 30 pages.

If you're referring to the quality manual, the 'form' I use is about 21 pages, 10 point Ariel, includes the 'Figure 1 diagram, complete index, references, etc. I don't think that's too long.

As a 3rd party auditor please stop giving me the regurgitation of the manual. I konw you dont mean it.John- a truley refreshing comment -
If I knew that YOU were going to audit our system - I would gladly "revert" to the style of our origional efforts back in 96.
(It was a "combination of" charts & COMPANY wording - on how we were intending to satisfy the standards language.)

I was told at the time that It was "not sufficient" and could not be effective because it "strayed" from the standards language itself. Our Auditors comment - I must see the standards reflected in your manual word for word - <u>mirror image</u>. (we even argued over minor wording differences - and vs and/or)

Well needless to say - I was at the time unanimous in my opinion - at that point even our local consultant was questioning my efforts although he understood what we had done - his position was we had "left ourselves open" to too many questions and arguments.

My management folks took a very strong line on this & cleaned up the issue thru the only channel they could control (that would be ME) ) -- told me to do "whatever was needed" to get through the registration - no need to stick to your guns at this point & have it be a cause for expensive 2nd or 3rd audits to obtain the registration - RIGHT?

Frankly - I can't POSITIVLEY - say our big gun mgr's "mean it" - but I can tell you "I mean it" and remind them "the standards require this-and/or that" every chance I get..

Question: what is the definition of “rolled our own”?

This is a long standing discussion, but I think an important one. I must admit that many of the Quality Manuals I review are reiterations of the ISO Standard. Some are purely canned products and for me, this says a lot about the organization using it.

Second Question: what does this group think the ‘masterpiece’ effort would look like?

Regards,

Kevin

> I was told at the time that It was "not sufficient" and
> could not be effective because it "strayed" from the
> standards language itself. Our Auditors comment - I must
> see the standards reflected in your manual word for word -
> mirror image. (we even argued over minor wording
> differences - and vs and/or)

This is precisely why I require a manual and why I wrote what I did. I do learn from experience (well, sometimes I do and sometimes I don't - but this time I did) that it's not worth a pissing match over words - which is what audits sink to quite often. Verbal battles and interpretative BS.

> Question: what is the definition of "rolled our own"?
>
> This is a long standing discussion, but I think an
> important one. I must admit that many of the Quality
> Manuals I review are reiterations of the ISO Standard.
> Some are purely canned products and for me, this says a
> lot about the organization using it.

In my military manufacturing days - and again when I entered automotive - there were requirements for a quality manual and/or a product quality plan. Somewhere in the contract there would be one. This was before ISO 9001 was popular - well, in the case of my Mil experience before ISO was released. Customer quality manual and/or quality plan contents were usually dictated more by bullet points (minimum contents index). So - you could sorta write your own. You addressed issues like how you deal with nonconforming product - but you wrote it and auditors were not looking for verbiage as the ISO auditors often do. Their interest was that a system existed, was documented and followed. You can see this to some degree in ISO 9000:2000 where they list the concepts. Since we all have ISO 9000:2000 handy (don't we? :confused: ) take a look at Annex A Figure A.9 - Concepts relating to conformity. There are some concepts auditors would look for. But they didn't pick your ass hairs over verbiage like the ISO auditors so often do. This is where I first understood the term Meeting the Intent.

One thing to remember is prior to about 1990 not many companies even had such a thing as a quality manual per se.

To me, Roll You Own is where you describe your system as it exists and that certain fundamental concepts exist within the system (such as segregation of nonconforming product as an element of your nonconformance system) without resorting to ensuring every single word in a 'standard' is - somewhere - repeated.

> Second Question: what does this group think the
> 'masterpiece' effort would look like?

I prefer the 'Roll Your Own' for every system except the quality manual. And it will look like - what you do (specific to your company). The 'quality manual' has evolved into - well, a standard within its self.<hr>I should point out that even though I talk about a 'canned' manual which I use for implementations and upgrades, I expect certain tailoring in each company. That is to say, there is the standard - word for word - and you have your references. You always have to take a look at the company and at the manual and at the procedures as a whole. Typically there are some 'notes' or other additions or clarifications added here and there.

As a 3rd party auditor I can only make one comment to those of you who are tired of auditors who demand manuals that mimic the standard word for word, who reject procedures because they are not in the right format, etc.

FIRE THEM !!!!!!!!

You pay them a lot of money and if you are not getting value treat them like any other poor supplier - GET A NEW ONE!!!


Until people start to to take control of their ISO registrations and demand that narrow minded auditors are no longer welcome the problems will continue.

Another hint - find auditors who have a lot of busines experience - especially those that have had excellent sales careers - they know what customers want.

Avoid the person who has spent an eternity as an inside resource in quality - they can write a procedure that looks great - no one wnats to uses it though.

Remember accountability to a customer for a quality issue is not the same as accountability to your company for the customer and the revenue generated

The easy answer is Fire Them!

You reach a point where you can't keep calling the registrar and telling them to "...send another auditor because this one wants us to ....". Or finding another registrar. It's an expensive, time consuming process. Hopefully a company will choose a 'good' registrar to begin with. But that in its self is not always the case.

Unfortunately - nearly all the auditors I have ever dealt with want to 'see the words'. For something so cheap and quick to do as a 'quality' manual (which I prefer clients call their 'systems' manual, it's simply not worth even going through the possibility of spending the time with a 'difficult' auditor. Anyone who wants to take a chance of getting an auditor such as you is welcome to take the chance. To me the odds are just not worth it and it's not a big deal.

> Until people start to to take control of their ISO
> registrations and demand that narrow minded auditors are
> no longer welcome the problems will continue.

I don't see it as a 'control' issue considering probably 80% (a guess) of the auditors out there don't think like you. It's line by line - by the book for them. My only true concern is an auditor's ability to see the requirements in light of the type, size, etc. of company they are auditing. For example, in an insurance company - what is nonconforming product and how do you deal with it? What does a corrective action system look like in an insurance company? It's these issues (like the auditor who did a writeup for use of whiteout citing legibility of quality records in the old 4.16 and one other clause I forget off hand) in a situation where whiteout wasn't a risk factor and the 'record' was not a defined quality record (which he decided should be - and demanded that "...next audit it will be one of your quality records..."). These are things which bring thoughts of changing registrars.

Me? I say sweat the big stuff. Don't worry about an issue of providing a quality manual which word for word repeats the standard.

Having worked for a registrar, I felt ashamed of myself for "taking the easy way out" and being "unimaginative" in creating a manual that follows the standard's numbering system, and being almost anal in making sure that I used all the key buzz words in each section. I did take a bit of literary license in saying some things but for the most part I just wanted to make sure that all the right words were there and couldn't be argued with.

At least this way, I feel somewhat confident that our manual will pass scrutiny and is one less thing for me to worry about.

It feels great knowing that the majority has done the same thing!

:confused: But now I have a question: Someone mentioned to me somewhere that I should consider having an appendix of approved procedures ( or attachment, or something) with the manual, as opposed to referring to the procedures within the sections. This was to allow me to add/ subtract, etc. the procedures without doing a revision of the manual.

The Organization Chart is something else that is supposed to be an attachment for the same reason.

My question is : are these pages rev'd individually then? Do I put some sort of rev level on them?

And in the page numbering of the manual (both on the page and as referenced in the Table of contents), are these attachment (or is it "appendix" ? ) pages listed consecutively or do they have a different numbering scheme? The org chart is inserted around page 8.

I have other things like a figure of the documentation pyramid, and a table of responsibilities for the QMS.

Any help is appreciated!:bigwave:

Put 5 quality managers in charge of 5 identical companies and you'll get 5 diverse views on what should be in the manual.

As one of the "made my own recipe" manual people, I'd ask this:

If we forgot about compliance with ISO 9001 and asked ourselves what should we have in the primary 'mother' document for our company (assuming a fully integrated system), what would we include.
Also, before being able to answer that, we need to determine what it is that we are attempting to gain from having this document.

Based on Marc's poll, and not wanting to start a bun fight, I'd say less than 10% of quality managers would be in a position to answer these questions. Aternatively (saving my rear end here), others probably can answer, but went for the safety net in terms of the appearance/structure of the manual.

So, how does your company benefit from the manual, and what did you put in it to meet these needs? (And therefore, why did you put the other stuff in it?)

For Lucinda's question, I'd say if you're expecting to update stuff that's in the manual more regularly than yearly, then just refer to it and make it a separate document (and make that manual smaller!).

Oh but Bloke, I have to have reference to my procedures in the QM.

And, as you say, the QM should provide information on my company that we feel should be communicated to whomever has an interest in the QM (like a potential client or outside registrar) So that is why the org chart is there. As an "attachment", I thought that it did make it somewhat of a separate document that was nonetheless connected to the QM. Doesn't it?

Lucinda, yes, reference it, as I said:

Originally posted by David Mullins
just refer to it and make it a separate document

My companies Quality Policy has to be in the manual, right? I reference it, and other policies, and other level 2 docs (system level procedures, if you like).

Org chart, suit yourself. Mine states position titles, not names, so I've left it in the manual because it is important, and something which was previously unknown across the organisation (can you believe). The names get aligned to the position in a system procedure called "level of authority schedule", which is a matrix of positions/people and responsibility categories, with the intersecting box describing the level of authority.

Forget the registrar. You've got a manual to provide the starting point/launching pad/GO space on the monopoly board for your staff to follow and understand the system. Second purpose is as a marketing tool - provided in tenders etc. So don't make it long and complex.

> But now I have a question: Someone mentioned to me
> somewhere that I should consider having an appendix of
> approved procedures ( or attachment, or something) with
> the manual, as opposed to referring to the procedures
> within the sections. This was to allow me to add/
> subtract, etc. the procedures without doing a revision of
> the manual.

That's the 'Master List'. They're nice in some cases. See Doc_Matrix.pdf in the pdf_files directory as an example. But I put references in every section - the relevant document(s) - within the quality manual.

> The Organization Chart is something else that is supposed
> to be an attachment for the same reason.

Keep org chart separate. Doesn't even have to be a part of the manual physically. Org charts are often frequently updated.

> My question is : are these pages rev'd individually then?
> Do I put some sort of rev level on them?

Rev and control like any other document. There are so many systems it's - well, up to you. With smaller clients, I encourage them to use date with a revision history on disk (past versions - not a listing of exact changes).

> And in the page numbering of the manual (both on the page
> and as referenced in the Table of contents), are these
> attachment (or is it "appendix" ? ) pages listed
> consecutively or do they have a different numbering
> scheme? The org chart is inserted around page 8.

When an auditor asks about the org chart we go to who ever controls it and show the auditor. Its not an appendix, or an attachment or anything but a stand-alone document.

You're over complicating things IMHO.

I have to concur with Marc. You NEED references (not attachments) in the manual to lead someone to the exact procedure that supports the process described without having to get anyone else involved! Unless you have very few documents or lengthy titles, I would surprised if (with very limited knowledge...not someone trained or already familiar with the system) someone new could take the ball and run with it...which is (IMHO) always the best learning method.

Yes, I know I have to reference the procedures. I structured the manual to address each part of the standard in order. Within each clause part, I have two sections: Policy,and Responsibilities. I used to also have a third: Procedures. So for 4.2 for instance, there is the general verbage related to our policy and practice for documentation, and then a part that describes functional responsibilities. With a third part there, procedures, I would list the applicable procedures such as control of docs, control of records..

But advice of one of my instructors was to not list the procedures after each section because we may add or remove(?) or change the name of, or whatever, the procedures and this would require a revision of the manual. He said that if I had an "appendix" of quality procedures that listed all the procedures in one place, then the "appendix" could be updated without changing the manual itself - or at least requiring a revision.

So the question is how do I number this appendix, and is it still considered a reference to procedures within the manual if it is an appendix - or would a statement under 4.2 referring to an appendix of procedures be "reference" enough.:confused:

So yes, I'm a big dummy. Completely clueless.

And I have little tables of information within the manual too,(like showing the structure of our documentation) and they are "Figure 1" or "Table 1", and I don't know if these pages are number consecutively with the manual or if they are un-numbered, or if they have their own little numbering scheme like ii and iii.:bonk:

This is what I was trying to ask. Is this any clearer?

Lu,
Lots of ways to do it.
Yes you're better off with the procedures referenced in one spot in the manual.
If you put it in an appendix with the intent of updating the appendix without revising the manual version, you'll simply need to control the appendix in addition to the manual. That is, list the appendix in you document register (or whatever you call it) as a separately controlled document, albeit an attachment to the manual.

Personally (And I'm one of the people who made up a structure to suit the company not the standard) I think you're overdoing the content of the manual. Document structure diagrams are great for awareness training, or even pasting in the doc control procedure, but not the manual. Likewise the responsibilities stuff. People won't (imo) go to the manual for responsibilities, they go to procedures or job descriptions. I'd use the structure and content of your responsibilities information as the basis for briefing management, etc, on their responsibilities - this is a course I actually run with managers and supervisors during the implementation phase.

In short, the advice you received was correct about not including things in the manual which will change on a regular basis (let's say more frequently than annually), as you'll be reproducing the manual for every revision. Keep the manual simple - That's been said soooo many times here, I don't know why people insist on re-writing 9001 as their manual.

PS - In the electronic version of my manual (accessed from a shortcut on everyones PC desktop which takes you to a basic index of the whole business sytem - without buying any software), the list of procedures (which is bookmarked (for direct hyperlinking) within the manual) is used as the master list (date of issue control stuff) and are hyperlinked to the procedures (files stored on server) for instant access. Likewise in the forms manual, job description manual, etc. The manual also contains an easy find index that matches words or phrases to procedures. So If you want to know the process for applying for leave you can look under leave, sick, annual, maternity, paternity, long-service, holidays, etc, etc. and they take you to the correct procedure or form. (I getting off the subject, but I'm trying to display the versatility of not being bound to a 40+ page manual that reverbages ISO 9001)

Hope I'm helping?????

Originally posted by Lucinda

But advice of one of my instructors was to not list the procedures after each section because we may add or remove(?) or change the name of, or whatever, the procedures and this would require a revision of the manual. He said that if I had an "appendix" of quality procedures that listed all the procedures in one place, then the "appendix" could be updated without changing the manual itself - or at least requiring a revision.

So the question is how do I number this appendix, and is it still considered a reference to procedures within the manual if it is an appendix - or would a statement under 4.2 referring to an appendix of procedures be "reference" enough?Ummm, yes and no. :ca: As always, depends upon the complexity of the company. But in most companies the answer is Yes. The references in the 'quality' manual are to top level systems and while the referenced documents may change internally, as long as the identification doesn't change there isn't an issue. So - typically referenced documents in a quality manual are almost always relatively stable. You're not going to have an organization chart one week and obsolete it the next week. Your level II nonconformance system document - the top level (level II) - will be there even if changes to it are made internally. Why would you want to rename a high level document like that?

The key is how far down you go in your references. You surely wouldn't reference a process instruction, as an example. If you did - yes - your 'quality' manual would be constantly under revision.

A simple way to tie everything together is in a document matrix. I guess you could make it an appendix. I don't see why you'd need to or want to. One I've had posted here for years as an example (a study in simplicity) is in the pdf files directory and as I remember it's titled Doc_Matrix.pdf. It ties everything together pretty well. It has really come in handy for my clients going through 'the upgrade'. Of course, we had, as in the example matrix I cited above, procedurs identified by disk file name or document title. So - even the ones with paper manuals - they already had 20 divisions of documents. We kept the 20 divisions as 'sections'. Because the ID of any given document was unrelated to the ISO 1994 numbering system, there was no need to change the base of their systems. I steered clients away from linking to the ISO 9K numbering scheme years ago. So all my client does is takes the blank manual (well, I'm doing the initial tailoring) and inserts the references from the old manual as they correspond in the new numbering / classification scheme. Two 'new' flow charts and - voilia - they're done. Time for the upgrade audit. This year I have gone through two and I have 2 on deck.

By the way - I just uploaded the base manual I've used with 4 clients now (remember - it's just the base. It has to be tailored) to the Members Access directory (it's been available to the premium folks - along with a lot of other stuff - for a while now). :thedeal:

Originally posted by David Mullins

PS - In the electronic version of my manual (accessed from a shortcut on everyones PC desktop which takes you to a basic index of the whole business sytem - without buying any software), the list of procedures (which is bookmarked (for direct hyperlinking) within the manual) is used as the master list (date of issue control stuff) and are hyperlinked to the procedures (files stored on server) for instant access. Likewise in the forms manual, job description manual, etc. The manual also contains an easy find index that matches words or phrases to procedures. So If you want to know the process for applying for leave you can look under leave, sick, annual, maternity, paternity, long-service, holidays, etc, etc. and they take you to the correct procedure or form. (I getting off the subject, but I'm trying to display the versatility of not being bound to a 40+ page manual that reverbages ISO 9001)Excellent way to bring everything together.

> Likewise the responsibilities stuff. People won't (imo) go
> to the manual for responsibilities, they go to procedures
> or job descriptions. I'd use the structure and content of
> your responsibilities information as the basis for
> briefing management, etc, on their responsibilities - this
> is a course I actually run with managers and supervisors
> during the implementation phase.

I do have some responsibilities defined within systems manuals for the main systems. Since the positions are high level, they rarely change in smaller companies so the issue becomes moot. The poit being, I agree that responsibilities are spread out throughout many documents / procedures/ etc.

After a little discussion with Marc, I think the size of the company plays a major role in determining the practicalities of the structure of the QMS.
Marc's base manual reminds me of the pre-1994 days when we used quality plans instead of manuals and layed out the responsibilities in the plan document.
I concede that smaller companies who go for certification are better off making compliance as transparent as possible, and thus benefit from following the Standard approach to structure.

However, I believe, to get the most out of your management system, you've got to be develop one that has a structure that is specific to the organisation, it's products, needs, customer types, etc. Benefits tend to be specifically targeted in this style of structural approach, rather than the across the board gains realised by companies implementing a proper management system for the first time.

So (in summary) I guess the size of the company and maturity of the management system both play a significant part in determing QMS structure.

My Rant of the Week:

I find David's post consistent with my 'signature' here where I clearly state: One size does NOT fit all. To me, every client, every company, is an individual.

There is no doubt that the size is a factor (only one of many). Not to mention complexity of the operation(s) and processes. The manual I shared with you was for a company of about 12 souls - total - manufacturing, office folks, and the company owner. It was 'tailored' (more than most because of the small size of the company) so that they did not have to write a bunch of procedures which they did not have before they went throuh implementation and do not need. It was akin to the 'old' Quality Plans because the company only does one thing - mix chemicals in their 3 'vats'. There was a reason for putting many of the things they do, as well as defining many responsibilities, right into the manual - no need for another document. Other than specific work instructions (individual batch mixture procedures, for example) the company only had about 8 to 10 procedures (flow charts) total. In addition, their whole 'systems manual' (10 point Arial font) was 33 pages, which included index, quality policy, etc., etc. When you only do one thing and you're that small a company, no matter how you do it it's going to look like a product specific plan - they unload tanker, pump into vat, mix, drain into drums or totes and ship. No heating, no chilling, nothing but mixing. Easier and more simple than baking a cake. Just a bigger bowl and a bigger mixer. Every day, week in, week out - for almost 50 years now that's all they have done.

Nor do they have the weight behind them (size factor), should a disagreement arise, to want to take a chance on an idiot auditor. Working with Motorola, we had a lot of leeway on many issues that involved "...showing them the words..." that this small company would have had a harder time arguing about. Heck - we had heated arguments several times over "...where the words are..." even implementing at Motorola (I will grant you that was QS-9000, not ISO 9001).

1994-95 was the turning point for me in turning to a 'copy the manual' approach. It was when auditors started the word game. Or at least 1994-95 was when I was first stung by the "...I don't see those exact words..." writeups. It was not enough to say "...We didn't write anything about identification and traceability because it's not relevant in what we do..." Nor was it enough, for example, in addressing 4.3.2 (the 1994 version) to not somewhere state list item B "...any differences between the contract or accepted order requirements and those in the tender are resolved...." The company could both explain and show where and how they did this, but the company was written up because they did not specifically state those words somewhere. I particularly remember that writeup because the company owner went ballistic saying, amongst other things, that's since they do it and can prove they do it, why are the exact words from the standard necessary? He asked where it says a company has to repeat every word the standard contains. The owner genuinely realized at that time that the document (ISO 9001:1994) and registration was not just the BS he had thought all along, but worse. Audits could end up as little more than pissing matches.
****************
The manual I reviewed from David was essentially the answer to a somewhat recent question: Can your quality manual consist of a list of references, a flow chart of your main system(s) and none of the verbiage at all from the ISO 9001 document? I must distill that to what it is - a List of Reference Documents approach which includes a column as to which clause of the standard the document satisfies. The list simply follows the numbering scheme of the standard. It is no more than a list of references - pointers to documents. In fact, if I had shared the document matrix with you from the small company whose manual I shared with you, you would see it looks much like your quality manual! You can see it, however, by downloading the 'example' matrix above. It's what that 'study in simplicity' was drawn from some years ago. And none of it has changed due to the 2000 revision. They only had to change their systems manual. Documents are already categorized, as well. Add the few extras like an org chart, basic flow of processes, quality policy, etc. and you could not say there is a difference between your quality manual and their document matrix other than that they put the 'compliance' words in their system manual rather than in supporting documentation.

I do agree with the approach where it's practical and appropriate. :agree: It's quite simple: It's a Cross-Reference Matrix. I personally feel it is the most logical approach. But I don't look at it as sgnificantly different. 'The Words' have to be somewhere and they are obviously in the supporting (referenced) documentation when you do a 'systems manual' from a list (cross-reference matrix) appproach. Where you put the words, in my opinion, isn't relevant. What is relevant is that they are someplace. Whether you take the time to write them in the 'systems manual' or in the supporting documentation, you're still taking the time to write it. This said, it will soon be known if the revised standard will change the way auditors audit. It's supposed to, but I haven't seen it succeed.

Often times it's simply a matter of an auditor not seeing the 'right' words. That's why I take the 'copy the standard' approach. It has not been a problem when an auditor says "...I see you say you do it, now show me and explain...". It HAS been a problem with an auditor saying (and this is the stuff I just love): "...I can see you are doing it and your explaination is fine - you obviously comply except you don't specifically state that you do that. Now, if you'd just add xxxxxxxx to your procedures or in your manual or somewhere we'll be in business..."

I have for years argued the 'intent' issue. Many people say "...intent, hell! If it says do it then you do it!..." Were that it was that simple. It goes further than that (in part) because issues of verbiage continue to pop up. I can hear the rumbling now from some auditors: "...Well, that's not the way I audit!..." That may be the case, but I can't be assured that every time an auditor visits a client for a registration or surveillance audit that you will be their auditor. I have to prepare my clients for 'worst case' idiot auditors. And I teach my clients to be ready to fight an auditor's interpretation if they believe it's a 'bad' interpretation. To do this it is, of course, requsite that they themselves understand the standard, what it is asking (requiring) and can relate it to their business. This is the reason I for many years argued against 'part time' quality people (consultants on contract for a day or a few days a month, really) even in small companies. I expected my clients to not need me any more after their registration audit. I believe it was discussed in a thread here where I was soundly thrashed by a bunch of folks saying "...we're too small to need a full time quality person..." That's when my 'enlightenment' came and I now explain this option to potential clients. This also came up in a thread where a consultant advertised that they would serve as management representative through the audit and 'hand the system over' after the registration audit. I freaked out because my paradigm was my responsibility as a consultant was to teach the people what they needed to know - including the standard, what the words meant and how they applied to their company.

I will say that when one starts talking about a 'structured' approach I want to scream. I have never had a client (this is not to say unstructured companies are not out there) that did not have basic structures in place. The little company whose manual you reviewed was well structured long before ISO. In so far as how one structures one's systems manual - I see that as a minor thing. One looks at what one has and defines what is needed. Then an approach is determined based upon what exists and what is needed. With almost every client I have had (maybe by luck?), they had systems which were if not compliant, nearly so. All they needed was to understand the standard (and how it applied to them), tidy up some loose ends and provide something to tie everything together - the 'systems manual' did that.

The same for the new 'process approach' of ISO 9001. The reorganization of the standard confuses more than clarifies. Process Approach and Structured Approach should both be in Bullshit Bingo! squares. Buzzwords. We're talking business basics 101 now. Of course, I also think the word Quality should be in one of the squares...

To end my diatribe - I want to cite two examples of how stupid some auditors are for those of you out there thinking I'm overboard on making first assumption that a client will get an idiot auditor.

Case 1:

An auditor comes in and writes a client up for something that a previous auditor (in most cases several previous auditors) went over (yes - in detail) and said was fine and met the requirements. Now we have a 'smart auditor' who really knows his/her stuff (obviously the other auditors didn't) and - all of a sudden their system is not compliant.

Case 2:

I had a client who registered back about 1997. They went along fine for several years. Of course there were the usual "...well, the other auditor was wrong..." incidents, but one day the company owner called me laughing his :ca: off. The auditor tried to cite them for ineffective internal audit system (a major finding) because for the last 2 rounds there had been no findings at all. I was in the middle because they contract their internal audits to me. So - why was he laughing? He stopped the audit and all went to the conference room. They got the registrar's representative on the telephone. The company owner explained the citation for an ineffective internal audit system based upon no findings. The owner explained that for the prior two years the registrar's auditors (visiting at 6 month intervals) came up with no findings. He explained that if the auditor was correct - that a lack of findings is evidence that the internal audit system was not effective - that it followed that since the registrar's auditors had no findings in their previous 5 visits that the registrar was obviously sending unqualified auditors and he wanted his money back all the way to, and including, the registration fees.

Of course, the 'finding' was dropped. It was decided that - gee, well, maybe no findings means that everyone is doing their jobs and doing them correctly. Personally, I wish he had kicked the auditor out the door and sued the registrar. While I won't name the registrar because of my link to clients which use them, I will say they are a major player in the registration game and have been for years.

Hope for the best, but prepare for the worst. YOU may get the Auditor from Hell!

> So (in summary) I guess the size of the company and
> maturity of the management system both play a significant
> part in determing QMS structure.

In addition to a few other factors. In summary, I agree :agree: with you 100% :thedeal:

One last thought: Enron and Mr. Lay. I wonder if Enron was registered.

I had come across the attached article and had downloaded it from the net - hope you all will find it interesting. It is related to QMS architecture.

Though the article is focussed on SO9001:1994 standards and software industry, IMHO most of it is applicable in the current context and applies to other industries as well.

These guidelines by ISO Technical Comittee clarify many of the issues that have been raised related to Flowcharting and Manual structure.

*** DEAD LINK REMOVED ***

Also see: http://www.bsi.org.uk/iso-tc176-sc2

It's the ISO TC 176 SC2 Home Page

Marc - when we wrote the manual we loosly followed the ISO / QS numbering. Since then we have revised here and there, and one of the changes I made was to align with QS numbering as close as possible in the level 1. I find this easier during audits and even internally when we do training involving the requirements.

I am currently looking to convert to TS, but am not sure if I should wait for 2002 version or go with 1999 version that I now have.

Here is a copy of a QM that I wrote for 9K2K you are welcome to download it and use it as your own (provided you make the necessary changes to fit your business). I would appreciate any feedback.

:)

--From a New Guy. Great forum. A lot of knowledge about this crazy mixed up world of COMPLIANCE.
--Of the 3 or 4 QMS manuals I've been a part of writing, I honestly can't remember too many times any format added a lot value to improvement of the organization. It's been more efficient for me to regurg the standard for 3rd party compliance.
--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.:thedeal:

Most tier 1 QM add no value that I have seen. Mostly a selling tool. The new standard helps in this area and I am glad to see that most companies converting to the 00 standard are in fact downsizing the QM.

Yes ! Isn't it interesting that the new standard is ever hinging upon actions resulting in bottom line improvments and satisfaction; As opposed to just a selling tool. There's hope for all us Quality Types, yet. It's about time !:agree:

Originally posted by noboxwine
It's been more efficient for me to regurg the standard for 3rd party compliance.

--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.andOriginally posted by noboxwine
Isn't it interesting that the new standard is ever hinging upon actions resulting in bottom line improvments and satisfaction; As opposed to just a selling toolWhilst I find the comments in slight conflict, and I'm sure they weren't intended that way, I would like to give noboxwine a job.
I'll write a Quality Manual which regurgitates the standard, and s/he can front senior management, middle management, fornt line management and the staff to explain how the primary document of the system should be ignored by them, as it's standard related crap that is inconsequential to the actual implementation and operation of the management system. No Personal Protective Equipment will be provided.

PS: It's OK to put wine in a box, that way you know which stuff not to drink.

Originally posted by noboxwine
--From a New Guy. Great forum. A lot of knowledge about this crazy mixed up world of COMPLIANCE.

--Of the 3 or 4 QMS manuals I've been a part of writing, I honestly can't remember too many times any format added a lot value to improvement of the organization. It's been more efficient for me to regurg the standard for 3rd party compliance.

--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.I agree with this post. I recognize that the standard does not require that the manual include anything more than the scope, the reference to procedures and the description of the interaction of processes. However I find it useful to include the policies in this document, and what that means is addressing the requirements of the standard; the path of least resistence here is to keep the structure and most of the words of the standard.

I've seen this provide some value in that there are many execs who wouldn't dare to read the standard but would spend the time to read and comprehend the quality manual. The manual can in a sense translate the standard for them.

Other than that, when is the manual most often used? I find that the most frequent audience is either auditors or the handful of customers who want a copy. With this in mind, the standard-centered approach makes sense. It doesn't make me completely happy, but it makes sense.

Beyond that, I realize that the policies themselves don't have near the impact that the lower-level documents do, so I prefer to spend my time making useful and usable flowcharts/process maps. These are the documents that people are actually using.

Julie

Originally posted by juliedrys
I prefer to spend my time making useful and usable flowcharts/process maps. Sounds costly on a consulting basis!

Is a "paraconsultant", like a paramedic - Someone with virtually no qualifications or experience but will take a look at it for you?

Originally posted by David Mullins
Sounds costly on a consulting basis!Indeed, it can be. It's more common for me to help them design the look and feel of the documentation and teach them how to do it. This is better for them in the long run anyway.

Sometimes we provide a technical writer (not at consulting rates) who's trained in the format. But there's always the small customer who just doesn't have the time or personnel to commit to writing documents. In any case, the content has to come from them.

On a related note, one of my customers showed me a fax they got from a company that was selling a CD of 250 "ISO Procedures and documents" for $199. Guaranteed to achieve registration! :rolleyes:

Julie

Originally posted by David Mullins
Is a "paraconsultant", like a paramedic - Someone with virtually no qualifications or experience but will take a look at it for you? :( Careful David, you may need the services of a paramedic some day. The ones I know, I would trust more than a lot of doctors.

Originally posted by SteelMaiden
Careful David, you may need the services of a paramedic some day. The ones I know, I would trust more than a lot of doctors.I was the quality manager of the first acute health ambulance service in Australia to be certified to an ISO 9000 standard, so I am confident I know (knew) the game from an Aussie viewpoint.

The definition of paramedic, causes paramedics concern!

As far as Doctors versus paramedics goes, no contest - Doctors hands down. I've seen too much first hand evidence of the results of paramedics when their skill level let the patient down (yes, that happens with doctors too, but from a statistical point of view - no contest).

[i]Originally posted by Jim Wade
Put the stuff required by clause 4.2.2 anywhere you like in your system and tell the registrar (in the interpretation document) that you don't have a Q manual but they can find scope, justification, procedures and process descriptions here, here and here. If they want to call those places collectively a Q Manual, fine.
[/B] I don't think you can get away with saying that you don't have a QM since 4.2.2 says that you shall have one and that within it you will have specific things. If you want to make the argument that these items live in disjointed pieces of documentation within the organization and therefore your QM lives here and there and there, well that just sounds ridiculous to my mind. Why make things harder than they have to be? If you have these items of documentation then why not bundle them into one place? I haven't looked up the specific definition of "manual" but I would hazard a guess that it means a compilation in one place.....

Originally posted by Jim Wade

We structure a system sensibly (with the business in mind) and then say to the auditor "we don't use the term Quality Manual, but the stuff you want to see is all there, isn't it?. Are you seriously going to run the risk of losing the business of being our supplier by insisting that we put those three bits together, when you can't explain how that will help us achieve 'quality'?"

And - to use your phrase - we "get away with it" :)

rgds Jim

Jim just curious who is your Registrar? How much do you pay to obtain your certificate??

"The quality management system documentation shall include:"

b.) "A QUALITY MANUAL"

Also you say write this for the auditors eyes only, on numerous occasions we have had our clients ask for the Quality Manual, you say it is not important for the Managers or people that do useful work to know where it is. I disagree espically where I work, becuase that is where we document our Quality Policy.

"The quality management system documentation shall include:" b.) "A QUALITY MANUAL"

Does that mean we have to title it a "Quality Manual"?
What if we title it Level 1 document?

We're talking spirit and letter here. What is the purpose, this is like saying that 4.1.2.1 mandates the use of org charts.
I have a book with the Level 1 - Quality Manual and the Level 2 procedures in it. It is for Registrar use only and marked as such.

Our Quality Policy is posted all over the shop and documented and controled in our "Business Operations Manual".

Originally posted by Randy Stewart


Does that mean we have to title it a "Quality Manual"?
What if we title it Level 1 document?

We're talking spirit and letter here. What is the purpose, this is like saying that 4.1.2.1 mandates the use of org charts.
I have a book with the Level 1 - Quality Manual and the Level 2 procedures in it. It is for Registrar use only and marked as such.

Our Quality Policy is posted all over the shop and documented and controled in our "Business Operations Manual".

Randy, call it whatever you want I don't give a darn if you call it a Business Manual or whatever. You guys think ISO is tough try working in an industry regulated by the FDA.

As far as for the Registrars use inly what do you show your clients when they ask to see your QM or whatever cute little name you give it? Do you tell them you don't have one?

You say your QP is posted all over the shop and it is documented and controlled in you cute little Business Operations Manual. So you also have a list of where the QP is posted in your shop correct? If you don't you should simpliy for the fact that if and when it is changed how do you know where it is and where it needs to be re-placed?

These are JMHO so take it as you see fit.

ISO Guy, we don't have a quality manual, and we told our registrar, and any one who asks, that we don't.

We have an intranet site that, amongst other things, (from ISO9001/2000 - 4.2.2)
'
includes

a) the scope of the quality management system, including details of and justification for any inclusions

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

c) a description of the interaction between the processes of the quality management system

'

ohh and we try not to use the 'Q' either.


To us this makes a lot more sence than having a great wad of paper with the word Quality Manual on the front that no one in the organisation will ever see.

The intranet site however, everyone see's, and uses to access forms, records, procedures, background to procedures, databases, upcoming news, performance data etc.

Granted we are not like private industry (we are a regulatory government department) and don't need to sell our services to anyone, but I have been there also and would never use a QM as a sales brochure anyway.

Remember that this standard was written for all types of business, in every country of the world, so there are going to be a lot of different approaches. And anyway, aren't we supposed to now be auditing with regards to the effectiveness of the system. If something is working, producing the results they want and meeting the requirments of the standard, how can we tell them that it is the wrong way to do things?

This is baloney. If the intent was simply to have this information available then it would have been stated that way. Like many other requirements. But it wasn't. The writers quite clearly said it would be in a manual. Period. While there will always be some folks who want a pat on the back for being "clever" in weaseling around this simple and clearcut requirement (as well as others), I think it is hogwash. I'm also not impressed by being able to bully or fast talk a registrar into what amounts to flagrant disregard of the standard, for this or any other requirement. Buying a cert is distasteful and receiving one for a system that is obviously not compliant by threatening to take business elsewhere is just that.

There is no allowance for a company to find business sense in the standard's requirements as a test of applicability. So whether or not a company thinks it adds value is quite beside the point if you are asking for certification of compliance to the standard.

Ok, so just my opinion. And an attitude forged by working for several years to guard the validity and integrity of the certification process.

The standard says

4.2.1 General

The quality management system documentation shall include
a) ....
b) a quality manual,
c)...
.....

Note 3. The documentation can be in any form or type of medium.
(my bold)


Then it goes on to define what is required in the quality manual

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any inclusions

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

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


It clearly says the documentation can be in ANY form or TYPE OF MEDIUM.:evidence:

My Intranet site is my Quality Manual, as well as a lot more. (but it is not a dust collector!)

This is in NO WAY weaseling around the requirements of the standard.

Originally posted by James Gutherson we don't have a quality manual, and we told our registrar, and any one who asks, that we don't.I agree that it can be in any medium. You score that point. But despite having the information available in the format of your choice, you still proclaim that you do not fulfill this requirement of the standard. Your own words. You say that despite having this electronic version of everything that the QM is required to contain, you don't have a quality manual .

So either you do or you don't. If you don't , then you are not meeting the requirement.

Ok I get what you are saying, I think. Perhaps I didn't explain fully.

That is what I told our registrar, "We don't have a Quality Manual per say.", then I said that "What we have is an Intranet site that fulfils the requirements of a Quality Manual" as defined in the Standard. BTW our registrar is the largest and most respected in Australia and they have no problems with it.

We don't use the word 'Quality Manual' anywhere, except in the cross reference matrix prepared for the registrar. I know that it (the intranet site) is 'in effect' a Quality Manual, but our staff just know it as "the web site".

This is something that provideds value for us and still meets the requirements of the standard. A binder with some pages copied from the Standard and the words "the organisation" replaced by a company name is IMO of no value to the organisation, the only value is to a lazy registrar. (I'm not saying this is about your QM, but about the majority of QM's I've seen.)

While there will always be some folks who want a pat on the back for being "clever" in weaseling around this simple and clearcut requirement

I guess I would rather be a weasel that brings value to the company I work for than a lemming that blindly runs the company down because he must conform to the letter.
Don't you see how rediculous this is??? Does it really matter what it is called or where the content is stored. Isn't it more about being able to show and prove that the intent of the standard has been upheld????? I have always attempted to go into implementation with the notion that the "ISO & QS standards do not prohibit the use of reason".
Here is a perfect example of why suppliers do the "ISO dance" as Marc put it. And why a certificate or registration means only that a system was found in compliance at a particular moment in time. The registration audit becomes nothing but a snap shot in time and losses it's intent and purpose.:ko:

So whether or not a company thinks it adds value is quite beside the point if you are asking for certification of compliance to the standard.
In other words - Resistance is Futile :eek:

Originally posted by James Gutherson
That is what I told our registrar, "We don't have a Quality Manual per say.", then I said that "What we have is an Intranet site that fulfils the requirements of a Quality Manual" as defined in the Standard. BTW our registrar is the largest and most respected in Australia and they have no problems with it.

We don't use the word 'Quality Manual' anywhere, except in the cross reference matrix prepared for the registrar. I know that it (the intranet site) is 'in effect' a Quality Manual, but our staff just know it as "the web site".
_____________________________________

Here's my perspective for what it's worth...

So you DO have a quality manual. You just choose to call it something else. If that makes you happy and suits your organization's needs, wonderful. Your registrar calls it a quality manual, so you meet the standard's requirements.

A rose by any other name...

Mike S.

Originally posted by Jim Wade


So, be contrite, and create a handy book (that's what a 'manual' is).



Sorry, I am not going to create a book. Our system is intranet, and that is what you get. Most of the auditors have liked the intranet format. I have used it for ISO 9002-94, QS and now 9001-2000. I have never had a nonconformance against not having a "Quality Manual" We have one, it is electronic. If auditors want an uncontrolled paper copy of certain areas for their use in the audit, fine. But I've never been asked to print out the entire portion of the web that would comprise the level 1 documents with the exception of the initial desk audit, and even then only 2 of the three implementations. The QS certification desk audit was done by e-mailing an electronic copy that the registrar viewed using his browser.

So, even though I think that to state we "don't have a quality manual" is perhaps a fallacy, there is no requirement to have paper copies floating around. Please try to remember that we all do business differently and just beacause you do something one way it doesn't mean it is the only way.

Obviously they have the electronic equivelent "We don't have a Quality Manual per say.", then I said that "What we have is an Intranet site that fulfils the requirements of a Quality Manual" as defined in the Standard. and their registrar was satisfied that it met the intent of the standard. How that becomes fraudulent, injurious to the integrity of the certification system, or anyone trying to weasel out of something is unclear to me. But, I'm just a good ol' country girl without a lot of book learnin' beyond my Associates Degree, so I guess I could be wrong.

Or maybe there's room to change your paradigm? :agree: :truce:

A rose by any other name...
You can complain that the flower has thorns or enjoy that the thorns have the flower!!!
As with the "Quality Manual" it's all in how it is perceived.
:smokin:

as long as you recognize that it is still a rose even if you want to call it a petunia...

Whether your QM is on the network, is delivered by lazer light show, or is spelled out with Campbells alphabet soup, you've got to have one. And it's got to have the critical elements. You cannot proclaim that you don't have one, and it should (iMO) be in a consolidated location. Otherwise, all you have done is have the required information available "somewhere". Which is not (IMO) what is implied by the requirement to have a manual. I believe the intent of the manual is to have this upper level information content in one assembled place to provide an overview of the company's QMS in a easy-to-see-it-all-at-a-glance and easy-to-distribute-to-all-interested-parties format. I certainly don't think that it has to be a hardcopy.

Regardless, I think that if you look critically at what you have and you find that you have assembled what you describe as your top level documentation in a structured place, you have built yourself a QM whether you like it or not. And if those required elements are nowhere to be found within that upper level documentation, then you fail to meet the requirements of the standard.

Steel, James' post regarding the fact that he does indeed have a QM negates any of my previous comments that may have been construed as being aimed at him. Apparently what his registrar witnessed was indeed the QM.

I do find it somewhat amusing that "interpretation" applied by a registrar as to the intent of the standard is welcomed and is not a dirty word when the "interpretation" call goes the company's way..... Otherwise the shouts are " where is the shall?" :vfunny:

Truce Lucinda?:truce:

As a professional paid to ensure that our organisation meets the requirements of the Standard I know what we have in in effect a quality manual, and my registrar know that too, but it is far more valuable to us than a book regurgitating the layout and words of the standard.

I'm going to leave this now, I know you must be upset with the Stars going from Division champs to out of the playoffs, and the mighty San Jose Sharks taking their rightfull place as Pacific Division Champions.

PS. I lived in San Fran for a while and just can't help having a dig at a Texan;)

I do find it somewhat amusing that "interpretation" applied by a registrar as to the intent of the standard is welcomed and is not a dirty word when the "interpretation" call goes the company's way.....

I agree with you Lucinda, and this is exactly what makes the water murky. Believe me, I don't twist our system just to make it more difficult for the auditor. I have to sell it to the company and to management in terms they understand and can accept. I may have to "repackage" it for the auditor in order for it to make sense to them and for ease of auditing (i.e. separate book, etc.) but I don't see it as trying to weasel out of something.

I know that the external auditors have a job to do and they have requirements to follow. But when they come into a work place it is viewed as a challenge to that company. My interpretations (or misinterpretations) may result in an NC, but the auditors interpretations or misinterpretations may result in lost jobs. Since I started working in this field I have seen 4 QMs and 2 ISO/QS Coordinators fired due to audit results. I'm sure there were some other factors in there, but the releases came after a bad external audit (2 registration, 3 surveillance, 1 upgrade). So you see when you (the auditor) place your quality system template (mind set) on our quality system(s) it may mean my job!
I remember the case study in the Lead Auditor Class where the company has the news media in house etc., etc. and you have to tell the CEO he is not recommended for registration. One of the first things the trainers did in the senario was to fire the QM during the closing meeting. It is real life.
In a perfect world we would all be on the same page, same paragraph and pronounce the words the same. But until that time we must remain flexible in our interpretations and ensure the intent is met.
:truce:

QUOTE]Originally posted by Randy Stewart
But until that time we must remain flexible in our interpretations and ensure the intent is met.
:truce: [/QUOTE]

I think the difference may lie in what we consider to be the intent of this requirement. I see it as an attempt to have the information in an assembled location, and others may simply see it as a requirement to have the information. I feel if the only requirement was to have the information, then a quality manual would not have been dealt with separately under the documentation requirements.

So perhaps that introduces a new line of discussion: Why was a quality manual specified to include these items of information (under 4.2.1 and 4.2.2) rather than simply listing them along with the other required documents in 4.2.1? The procedures (4.2.1c ) - or reference to them - and the Policy (4.2.1a) are components of the Quality Manual (4.2.2). The QM does not exist without these two components - why did they list quality manual as if it is a separate and special sort of document?

Bear with me, I'm playing the pick-it-apart game to try to understand the intent.......

So while the QM can consist of the whole bucket load of procedures plus the two additions...(a network site with everything in one place), A simple directory of procedures without the two additions does not constitute a QM, right?

Which brings me back to the first question, why weren't the additional items (description of processes, scope of QMS) listed among the general documents section 4.2.1? Why even mention a "quality manual" at all??

What is the Quality Manual supposed to bring to the table?

I think that the new standard used the info from the registrars, the registered, consultants, etc. to make the standard better, as in the case of the QM (Tier 1). Everyone knows that the only areas of real info. in the majority of the 94 QMs were in 4.1 and to some extent in 4.2. Generally the rest of the QM was a waste. I applaud the change. One knows what is needed by 4.2.2, if you want more - go for it!!!

Absolutely right Lucinda.

If we can bend the rules that far what else can we get away with ?

No training perhaps ?

No management representative ?

No calibration ?

In fact nothing that is required in the standard ?

What would ISO9001 certification mean under these circumstances ?

My experience would say that the Quality Manual only brings dust to the table. Reason being is that it is only referenced during an audit.
The Quality Manual is a high level document that outlines the basis for the system - an outline. It provides targets for the overall quality function of the business. In other words a place for the auditor to start (doc audit). The normal everyday function of the business/system is governed by the process flows, procedures and work instructions. These SOPs (if you will) are derived from the targets outlined in the manual.
(This next item maybe the cause of our disagreement) QS requires us to have a "Business Plan" (4.1.4) to show where we want to company to go. IMO if these 2 documents don't mesh you will see a complete breakdown of your system. You have 2 plans or manuals that can't see eye to eye.
If we can agree on these 2 premises, we can come to the understanding that a blend is necessary. By requiring that the 2 be separated and maintaining a "pure" QM it promotes and drives the separation between MFG and QA.

OK so the Quality Manual might only be used by auditors, but as it is part of your companies desire to have ISO9001 certification because it opens up business for you, then your QM adds value to your business.

Doesnt it ?

I don't remember any of us stating that the QM didn't add value. The issue was the interpretation of what a QM was (form or function). If I read your question right, you're advocating that keeping a QM just to maintain or get a certificate is beneficial?? I can't believe that, it must be a misprint!!!!:eek: :vfunny:

What I have attempted to do here is to integrate our systems (MFG & Quality). By maintaining and using a separate book titled "Quality Manual" it negates this integration.

Majority of the items I have talked about and have had my arguements about revolves around this integration. Our manufactuing operations must embrace, believe and implement the "Quality Objectives" or those of us in the US auto industry are doomed. JAMA members have done this for years, it is such a stretigic part of their organizations it isn't even discussed - it is their culture. You will not hear a Toyota employee talk quality outside of the operation/process, because they are so intertwined they are one in the same. They don't have Quality Manuals, Business Manuals, MFG Manuals - they have 1 and it's an Operations Manual, there is no separation.

This is why I will not operate with a separate "Quality" manual. I'll have one for the auditor and it will be maintained.

It has taken me 3 years to get this far in integrating and I'm not going to change in order to maintain a certification. Our customer is now our parent company and the outside supplier requirements are no longer applicable. We do not maintain our certificate because of the business oportunities, we maintain it because we believe in the system.
:thedeal:

I know that I come to the forum to find better ways of doing things, not ways to circumvent the rules....

I have all of our quality system on the intranet, with a central access point, sort of a "one stop shopping" site. My long term goal is to be able to do management review from this site, as well as have it as a general access point. I have a "quality manual" there, as well as procedures, forms, reports, corrective action system, and all those other things that help a factory run right. The necessary information is available to any computer terminal in the company. Copies can be obtained from a printer.

ISO 9000 is a model for a quality management system. I am rather dismayed that the focus goes to the word "quality" rather than "management". Every business has a management system. Maybe it isn't documented, and maybe it doesn't work well, but it is there. I am sucessful in my heart when I make this management system work better. Quality is inherent in a properly operating business. We all know that!

I really think something is seriously wrong when a company perceives that it must have more than one "manual" to describe it's business model. I agree with what Randy Stewart is talking about, an integrated system. Why can't the quality elements be integrated into an "operations manual" or any other description of the overall management system? Or, for that matter, what is the real difference between them?

There are really two seperate issues to consider here, firstly obtaining a certificate for contractual reasons, and secondly operating an effective QMS. Each has its value, and the best companies combine these two desires. However you must appreciate that not all companies are multi-national conglomerates that have huge potential cost savings/wastes that necessitate a mature and effective QMS. Most companies are small businesses that just need the certificate to do business - this does add value to the business and is worth doing, however battling with a registrar over some arty farty QMS has little benefit to them.

Get over it guys.

I also think that hiding the term 'quality' so that it is almost non-existant does not serve the true purpose of the QMS or the business. What do we do, not comply with ISO9001, not talk about quality, have no quality manager or quality staff - just hope that people have been born perfect ? Wishful thinking guys !

The main priority of receiving certification isn't for a debate with the auditor. Nor is it to show-off how tricky or slick the system is. I don't care if the new title of the QMgr is Convicted Felon and the Qual Manual is called the Book of the Dead. Does the system operate within the parameters and guidelines of the standard and does it meet the requirements, should be the questions asked.
Maybe I'm wrong in believing that there are different ways to comply, but I don't believe that the standard was drawn up to be a cookie cutter where every companys' system would look the same.
Just because I dust off a "Quality Manual" for the auditors doesn't mean our system isn't in compliance. I have a ton of objective evidence to prove we comply.
Going over our discussion here, isn't it obvious how interpretations vary from individual to individual. I've been through the classes and been through the audits, and I still may look at issues differently (no doubt). If I'm wrong, I'm wrong but there is still enough auditor in me to say "show me".
I have really enjoyed this topic and I trust that no one involved feels I have picked on them or challenged their professional expertise. Honestly.
:agree: :truce:

they must have a certificate, will be defensive and make their own business-oriented interpretation. You are in the latter category, it would seem?
The requirement by our customer(s) isn't there anymore. We don't have to maintain the certification. GM & DC never have required us to be registered because we do prototype work for them and Ford no longer requires it because they own us now (wholly owned subsidiary).
I worked with the Dearborn T&D guys to get them ready for their ISO registration and assisted in developing the R&M requirements (TE-9000) for T&E design houses (mainly production fixtures and dies).
Currently working on the move to TS16949. I guess you can put me in that group, we are maintaining until we register to the new "standard". It's just not a must.

Does anyone give copies of this manual with supporting documents to each department? Such as specific procedures pertaining to their dept., forms pertaining to them.......etc.
I've done this because upon implementation of our "new" system, I felt it was the only way to get each dept. familiar with the procedures and also to verify the procedures match what they are actually doing (even though I asked how they did things in the beginning)

Yes. Everyone here can access our manual and all procedures - on the intranet.

/Claes

Interesting thread, I voted for the tailored approach and here is why. In my life as a QM and consultant I see two roles for what I do ...

1. translate ISO 9k2k, 14k, etc etc requirements into language the people I work with can understand and

2. translate the work that the organization I work for into words that the external "experts" can relate to the wording they are used to.

I prefer to do the second part in person but will (at a push)provide a cross reference of organization's processes and sections of the highest level document / intranet site to those clauses that he / she needs to tick off on the audit plan before he / she can give me the certificate.

obaraguy said:

Does anyone give copies of this manual with supporting documents to each department? Such as specific procedures pertaining to their dept., forms pertaining to them.......etc.

Not sure if this will help you or not, but all of the work instructions are named to denote the area they pertain to, i.e. LB-001 would be for the lab, SA is for sales, etc. we have an index with the work instructions entered under their corresponding areas. The forms are also listed under the area where they are filled out. If there are work instructions that are for ALL employees, they are named GN for general.

We also have created an SQL data base that controls documentation. Each document has a "route" associated with it so when changes are made everyone on the routing list is notified. I think I had stated somewhere in previous post that these notifications are tied to the employees' time cards electronically and must be read and acknowledged before the timecards are submitted. The notices clearly state that if the employee does not understand the revisions they must contact the supervisor or manager of their area. The acknowledgements are saved as records for training purposes.

obaraguy said:
Does anyone give copies of this manual with supporting documents to each department?

We dual systems since the 'shop floor' doesn't have access to the intranet..but then again, they rarely ever ask or need to refer to higher level documents. All staff (including supervisors and leadmen) can view the intranet which has Quality Policy, QA Manual, Specifications (Product, Material, Test Methods and Process), Work Instructions, and Forms. The SOPs are posted at point of use on the shop floor along with a manual containing any work instruction needed for reference in that department (and forms are in filing cabinets in dept used as well as master copy at the copier machine).

I have just rewritten our Quality Manual. Although the 1994 version was number using the standard I felt as though the 2000 was easier to use key elements and reference the standard in the paragraph. Since we are a small manufacturing chemical company I struggled with the exclusion for design but have given the draft to the upper management for review. He chuckled when he read my mission statement (I don't think that this was required, just looked good) and asked where I got it from because he didn't think we had one!!!! My interaction is basically a diagram with arrows going back and forth between each section (Management, Customer Service, Manufacturing, Logistics, Lab, Purchasing, etc.) to our main focus of the customer. Since we have decided not to hire a consultant, I have had quite the task. I started with the quality policy (added to the existing to meet the requirements) and then went to the manual. Now I am getting to the nuts and bolts of the new standard. These forums and the workgroups that I have joined have provided me with lots of information. Thanks for all who read and have responded to my questions.

Does anyone think the quality manual is really useful. Of all the documents I think are needed for a quality system, this one is one I see as absolutely being unnecessary. The document usally resides in a file cabinet (or network drive) and only comes out for customers or auditors. Am I the only one with this opinion?:thedeal:

Agree, after the desk audit most auditors never look at it only the customers request it from time to time. The 00 standard does make a move toward a more useful document.

The Quality Manual in my QMS is the single point where all of my procedures, work instructions and other quality related documents come together. It is the table of contents of my entire QMS. I created it because the standard said I had to have one ... for the registrar to give me a certificate.

Understanding this relationship bewtween workers and a quality manual, I took the context of the QM and created the same table of contents affect in a graphical format I called a Process Mapping Tree (PMT) using standard flow charting symbols. The result is a lot less text, but the exact same road mapping of all procedures and instructions within the QMS. The outcome has been great. My employees use the PMT on a daily basis to perform the necessary quality functions while the actual QM is hardly ever used. In effect, I gave the employees a simple EQUIVALENT tool they understood and use all the time. On the other hand I left the text driven, dust collecting QM for the registrar because they required it and the text driven format is what they are use to seeing. My next step is to convince the registrar that the PMT is THE quality manual and thus have one less document to update.

tarheel said:

Does anyone think the quality manual is really useful. Of all the documents I think are needed for a quality system, this one is one I see as absolutely being unnecessary. The document usally resides in a file cabinet (or network drive) and only comes out for customers or auditors. Am I the only one with this opinion?:thedeal:

I have NEVER used it for anything other than 3rd party requirements. Waste of time, space. Just as useless as 5.5.2- "shall appoint .......Management Rep". Duh...............:bonk:

I can't believe I am still doing this for a living. What a joke.

In most cases I would agree that companies make the QM very generic and it only states the shalls. But if an organization looks at ISO or QS or TS and sees that it could help them and not just go through the motions, then they can add to the shalls and build a solid quality manaual that acts like a company overview and references meaningful procedures. The policies located in the QM don't have a lot of meat but they should say something about the organization in a way that makes customers feel like the process actually means something. I get sick and tired of reading posts on this site that imply that the ISO / QS / TS / AS / etc. standards are just a joke or a front for money making. If a company is serious about the process and actually utilizes tools to improve based on the guidance from the satandards, then it obviously will help. Nothing is free in this world and as long as customer require things, suppliers will do them. The question is which companies will do them as a minimum and which companies will truely implement and try to get better. Customers what cheap services and suppliers, but they also what it done right the first time.

Companies that are required do get certified, but take it as a way to truely improve business are the ones that customers will go to, because the outputs will be better over time.:bonk:

Say what you do; do what you say and get better at it and you will have success. Get certified because you have to and don't put much stock in it and join the rest of the chapter 11 companies out there that could not stay afloat in the lean times. I am not saying that QS is the saviour of companies, but it is a good tool that can assist a company in it's quest to get better and more market share. Any company can say the are "High Quality On-Time" but prove it to your customers, or better yet to potential customers. Implementing a meaningful and useful system based on a standard should be seen as a improvement tool and technique rather than a requirement.

I will get down off my soapbox now.

MrPhish, I would be very interested to see what you have done, if you are willing to share. It sounds interesting. Send me a private message and I will give you my e-mail. Thanks.

Tarheel, I originally posted a JPG copy of my PMT on this other thread: ISO 9001:2000 - Types of Processes Other Than Product Realisation Processes (http://Elsmar.com/Forums/showthread.php?s=&postid=35679#post35679)

My post and file link are at the top of page 2. Also be sure to check out Julies sample file at the bottom of page 2.

Thanks for the input. Good job. I really like the concept

I work for a company that has many plants and 1 corporate office. Every site (including corporate) holds their own separate certificate, however corporate is listed as a "supporting function" for all sites (for design, purchasing, etc.).

We are currently beginning to transition the plants to TS, but still have QS plants. To make it even more confusing, our corporate office is registered to ISO 9000:2000 (since we, as our own entity, don't meet the requirements to be QS or TS). So, our quality manual covers: QS-9000, ISO 9000:2000 and TS 16949:2002.

I agree with the majority that the quality manual is a bunch of crap. But I have the registrar keep saying to me that especally with TS and ISO 2000, it should be a valuable document. (I think they just want document review money...)

But I do have a question. One of the requirements of ISO 2000 and TS 2002 is to have your processes and the interrelation between them defined in your QM. Has ANYONE figured out how to do this yet???? (for a company that does more than sort rocks...). A project in our company could take about a million different paths depending on the nuances of the customer. It would be next to impossible to create a flow chart with more than 5 boxes but less than 200. Our registrar hasn't rejected the manual yet (of course, I just sent it in this morning...). Anyone have any ideas? :frust:

Hi KM2red,

Dont' get to bogged down in trying to define every product path.
We broke our flow down into the major departments such as sales, purchasing, manufacturing depts, etc. Then I listed what some possible inputs and outputs would be. Our auditor said that was suffiecient to satisfy the standard. Here is a quote from their own interpretations they give their auditors. "The org. is not required to produce system maps, flow charts, lists or processes, etc. as evidence to demonstrate that the processes and their sequence and interactions were identified. Such documents may be used but are not mandatory." I think that gives you a lot of leeway, of course your registrar may have different interpretations.

:ko:

I'm beginning to think the word "interpretation" means "what ever will make me the most money". I had an instructor come through for a TS Implementation class telling everyone that the QM only had to be 5 pages long and the processes and their interactions could be defined by the flow chart in the 9000:2000 standard. (this, of course, made him VERY popular with the ISO coordinators who hired them for site training).

My registrar thinks you should list out all of your processes and their interactions. (hence: a longer documentation review and most likely (although: Please God no....) modifications needed to the manual and another doc. review).

For 9001-2000 many are using the cross reference table provided by ISO to show interrelationship. If you have a reference section in your System Procedures that will show it. Many are using the model provided in the introduction.1 We have taken the approach that the old 94 elements are now processes (sub).

gpainter,

I'm kinda dense sometimes. I don't understand what you are saying. Could you elaborate please?

This was in response to KM2RED's post. Most seem to be taking the interaction of processes to extreme! If it adds value to the system then "go for it" In the introduction section of the standard .2 process approach last paragraph shows and says it all. The chart in the same section figure 1 clearly shows the distinction between the processes of the QMS and the manufacturing processes.

gpainter said:

The chart in the same section figure 1 clearly shows the distinction between the processes of the QMS and the manufacturing processes.

I agree, but the reqirement of the standard is:

"4.2.2 c.) a description of the interaction between the processes of the quality management system."

Which I (and my registrar) interpret as how does sales interact with purchasing, etc. Our problem is, sales could interact with purchasing a million different ways or not at all. We have so many areas of engineering, and the path that one product takes (and the interaction between those processes) is not the path that another product will take.

So...I end up with:

Sales--->Design (although, not always)---->Purchasing----->Manufacturing

as a flow chart, or a flow chart that is so convoluted, it doesn't do ANYONE any good!!! :bonk:

km2red

I am sure in a few years time we will be questioning the value of this process 'map' required by the standard (if not already).