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Author Topic:   QA Manual ISO 2000
Dudu Mtshali
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posted 11 July 2001 07:28 AM           Edit/Delete Message   Reply w/Quote
How do you structure the QA Manual for ISO 2000

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Russ
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posted 11 July 2001 08:38 AM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Dudu,
You need to download a copy of ISO 10013, it will help explain quality manual developement. You can get it at www.ik.bme.hu/~mohacsi/sqm/documents/10013.html

*****************
Fixed the 'auto-link'

[This message has been edited by Marc Smith (edited 03 August 2001).]

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Carl
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posted 11 July 2001 11:30 AM           Edit/Delete Message   Reply w/Quote
DuDu,

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

Good luck,

Carl-

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Marc Smith
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posted 11 July 2001 11:42 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
-> copy sections 1 through 8.5 of the standard, VERBATIM,

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

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Russ
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posted 11 July 2001 10:12 PM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Is it really that simple to make a manual like this? If that's all it takes I think I will write a new one for 9K2K. Then use a matrix to our present procedures etc.? And fill in the gaps? Am I just making it too hard?

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Marc Smith
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posted 11 July 2001 10:23 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I'll betcha that's been said here in at least 50 different threads from time to time.

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

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Jim Biz
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posted 13 July 2001 11:12 AM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Are there copyright considerations needed?

Regards
Jim

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Marc Smith
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posted 13 July 2001 11:20 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I guess they could get nasty, but since there are probably thousands of companies which have written their manuals this way, I doubt the ISO folks would take a chance at pissing off a whole lot of companies by bringing an action against one. I'll tell you what, there would be an interesting (to say the least) debate if they (the ISO folks) actually did take a company to court over copyright violations in the company's quality manual.

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Russ
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posted 13 July 2001 02:17 PM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Just want to thank Carl and Marc for the ideas on making the QM for 9K2K. You were right on the money, took me about 4 hours to complete it. Already had it typed into Word, so that made it easy to copy and paste until I was satisfied with it. I think it will fly!

Russ...with his eyes wide open

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Al Dyer
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posted 13 July 2001 03:19 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
Russ,

Good for you!

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

ASD...

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Russ
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posted 13 July 2001 06:52 PM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
AL-
No need to worry about that. Now that I have it roughed in I am going back over it and making sure we are doing just that. The Gap Analysis helps here, and fits right in with the matrix to the procedures. I guess now the biggest job I have is extracting the few procedures that have been included in the QM that didn't need to be there. I need them, but in the procedure section not in the QM.

Russ...starting to see the light!

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Andy Bassett
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posted 01 August 2001 01:32 PM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Could you come back to me on this one, as it all seems to good to be true. Just to check my understanding, how would you rewrite for example section 7.5.2 Identification and Traceability.

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

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

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


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

Regards

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

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Marc Smith
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posted 01 August 2001 01:57 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
This is from an audit a month ago. This does not relieve you from having to be ready to explain everything.... In this case they probably should have referenced their design process map in 7.5.2. Oops!

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

7.5 Production and service provision

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

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

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

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

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

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

Supporting Documentation:
Quality Control Map
Delivery Map

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

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Russ
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posted 01 August 2001 02:35 PM     Click Here to See the Profile for Russ   Click Here to Email Russ     Edit/Delete Message   Reply w/Quote
Do you really need Supporting Documentation: after each section when you point to a procedure matrix that connects everything? Where should I reference this matrix? I have it referenced in 4.2.2 now, should I reference it in all sections?

Russ

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Marc Smith
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posted 01 August 2001 03:16 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Well, ISO 9001:2000 states:

4.2.2 Quality Manual
Also see: 4.2.1b

The company shall establish and maintain a quality manual that includes

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

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

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

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

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

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

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

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Andy Bassett
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posted 02 August 2001 05:46 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
I am still hesitating a little before taking this route. A verbatim copy of the ISO 9000 standard does not tell an auditor how the company is complying with the standard. My guess is that this will have to be added in some way, in which case you end up writing a complete Quality Manual, and inevitably doubling up on the content that exists in the Processes and Work Instructions.

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

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

Thanks for input so far

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

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Marc Smith
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posted 02 August 2001 07:33 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
-> I am still hesitating a little before taking this route.
-> A verbatim copy of the ISO 9000 standard does not tell an
-> auditor how the company is complying with the standard.

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

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

Nope - not really, see the following...

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

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

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

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

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

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

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

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

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

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

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

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

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Andy Bassett
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posted 03 August 2001 04:00 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
OK Marc, point taken.

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

Regards

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

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

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Marc Smith
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posted 03 August 2001 06:13 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I try to pressure the company to do it. They almost always do. It's really pretty simple. One key is to not try to write your quality manual and then write procedures to fit it. Start with a matrix and document mapping with consideration to your gap analysis results. Have the main body of the manual (the ISO text) set up and ready. As your matrix fills out, you go to the appropriate section of your manual and insert the appropriate reference. Again, I admit this is redundant because technically you have the matrix.

A word of serious caution here

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

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

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

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HFowler
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posted 17 August 2001 04:13 PM     Click Here to See the Profile for HFowler     Edit/Delete Message   Reply w/Quote
I attended a meeting yesterday of regional quality professionals and one of the ISO Registrars said the following question was raised at a session he attended in Cleveland, OH recently.

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

Any comments??

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barb butrym
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posted 19 August 2001 12:53 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion). that said, obviously it is easier to audit to, especially for doc review...but then I never was one to take the easy road.

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David Mullins
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posted 19 August 2001 08:14 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
One Page?
Why not!
What's the problem with that?

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

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Marc Smith
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posted 22 August 2001 05:54 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by barb butrym:

I hate it, as an auditor when i see a quality manual written verbatum. its shallow and meaningless.....and obviously created just to meet the standard as quickly and painlessly as possible and shows me there may be a lack of real commitment and i must look closely elsewhere (strictly my opinion).


A 'quality manual' is bunk. I totally disagree that "...its shallow and meaningless...". Please, please tell me. What do you expect of a 'quality' manual? Why is it important beyond serving as a skeleton to hang things on?

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

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

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

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

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

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

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

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David Mullins
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posted 22 August 2001 08:32 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
I should have said that I support the theory of a one page manual. My reality has been that by the time you kick in a matrix, a flowchart, introductory and marketing-type statements (for customers who request a copy of your QManual with tenders), then referencing policies and procedures it ends up more like 7 or 8 pages.

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

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

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Alf Gulford
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posted 23 August 2001 12:58 PM     Click Here to See the Profile for Alf Gulford   Click Here to Email Alf Gulford     Edit/Delete Message   Reply w/Quote
I skimmed the forum and don't think I'm repeating much here.

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

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

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

Alf

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HFowler
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posted 23 August 2001 01:38 PM     Click Here to See the Profile for HFowler     Edit/Delete Message   Reply w/Quote
The idea of a 1 page Quality Manual is probably an exaggeration. I raise the question in this forum because I am interested in developing a FIRST TIME Quality Management System for our company that is VERY, VERY SIMPLIFIED, easily understood and maintained.

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

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

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

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ikar
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posted 23 August 2001 05:31 PM           Edit/Delete Message   Reply w/Quote
A "small" QM was discussed 3 weeks ago in https://elsmar.com/ubb/Forum15/HTML/000303.html
and I repeat some my words: ".. it was last July in Kyoto during ISO/TC 176 meeting. It was an Open Forum and we discussed one ( among all others) suggestion “Is it a real need in documented Quality Manual”? The answer was “yes”, but the descending importance of QM became clear."
As for registrars: their real interest in QM is in OrgChart ( to prepare an Audit Plan) and in Procedures Matrix ( to define a scope of Adequacy Audit). I understand them. Many QMs look like "brothers and sisters".
As for Sales: I think that an illustrative, not tiresome Quality Comics, written in a friendly easy manner is more attractive than an ordinary QM. Does your client really want to know what do you do with "identification and traceability"?
I hope we'll see in future such pleasant QMs. They should provoke staff to read other Quality documents. ISO 9000 isn't an amusing book. Let us do it so.

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