I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragragh or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

Boy, I've seen lots of different approaches to quality manuals, but I must say that I've never heard of a quality manual that small. The QS9000 manual says that you have to prepare a quality manual that ". . . covers the requirements of this international standard. The manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system." I would have a hard time believing that you can address all of this in 3 or 4 pages.

You *might* get a registrar to buy it with ISO9000 by showing everything is covered elsewhere (in tier 2's, etc.), but I seriously doubt it would fly. I would ask for a copy of a Quality Manual from the company claiming to have done this which is currently registered. I've never heard of Company Confidential Quality Manual. Share it with us.

I simply do not believe it. I want evidence.

Dawn,

I believe you are on the correct path. In agreement with Marc, placing policy (level 1) into the procedural level documents (level 2) makes it difficult for a Registrar (anyone for that matter) to do a good desk study. This may lead to problems during registration. This unstructured Quality Program method is the road less traveled, and probably for good reason. I would not recommend this method, although I have seen it work (to my amazement). Lengths for Quality Manuals will vary greatly. 3-4 pages? I'd have to see that to believe it. My original Quality Manual was 24 pages and was inclusive of some of the Managament Responsibility and the Quality System element points. If you add the organiizational charts, then 30 pages.

I may have been a bit more wordy in the Quality Manual than in our procedures, but I thought it more important to make this document an easier read as well as more visually appealing to our Customers. Generally speaking, a Customer will request the Quality Manual for your company and not the Level 2 documentation. How would you, or the General Manager in your company, feel handing out a 3-4 page Quality Manual? Is this how Senior Management wants to sell the company's commitment to Quality? Probably not. It sounds to me that you may be on the right road.

I agree with Kevin.
Our QM is 30 pages and includes references to the level 2 documentation. Customers want to see this and we give it out all the time to them and by their reactions this appears to be what they want.
I suggest that the copies that you give out to customers etc. are marked "uncontrolled copy" this prevents problems with document distribution etc, and shows that you are aware of all the ramifications of controlled documents.
All the best

Up until about 1994 you could often get thru ISO with a very abbreviated quality manual. As time has progressed interpretations and expectations have drifted. I have a quality manual for ISO9002 somewhere in my mess here which is 14 pages. It wouldn't fly now.

In ref. to the size. My Procedure Manual not including the Visio Flow Charts relating to Procedures is over 50,000 words. The Quality Manual is over 35,000 words. It covers every thing. We have to realize that mistakes will happen so we need to prevent Major non-conformance to QS requirements. So don't hide anything. My new E-Mail is bmay1913@aol.com
Bill from Ford at Sharonville, Ohio

Ask your superiors "what font size for a 3-4 page quality document?" I think they must be refering to each element in the manual should not exceed 4 pages.

Hi you all quality gurus!!!

I need a BIG favor from all of you.
Im in this quality course, and i have an assigment, that i need to look into the internet for the Quality Manual of an Automotive Factory, such as FORD.

Does anyone know where i can find this or someone has it please notify, could you send it to me, please!

Thanx YOU GUYS!

Telefonia,

I am sure someone from Ford will be able to help you out with this. Not sure if Ford Quality Manual is available on the net though.

There are a lot of QS manuals from many other companies that you can find if you search using Google. Most would be in PDF formats. Yoy can download them from the internet and study them for your assignment.

Good Luck!:bigwave:
-Atul.

Does anyone else give copies of their manual to each department with procedures and forms specific to that department? Or am I the only one taking this approach?

I thought it would be a good way to "ween" each department into a QMS that they are not used to.

Comming from a smaller organization, we have taken the approach of giving manuals to the managers (about three sets of manuals per facility- each set includes a Level 1 Policy Manual, Level 2 Procedure Manaul and Level 3 Work Instruction Manual) and posting the work instructions on the equipment. We have a master forms binder in the front office that people can use to make copies of the forms they need, or they have forms (corrective action - tags and such) located throughout the shops.

IMO a quality manual is just a re-print of the standard (QS), including customer requirements with the "shalls" and "shoulds" removed and replaced with the present tense. Include a procedure reference with each requirement and you're done.
Number of pages, double sideed, 25-50.

This is a REAL old thread, but it got me to thinking... So - Today I added a poll.

How big is YOUR Quality Management System (QMS) Manual {aka Quality Manual}?

By the way - This thread started out addressing a QS-9000 manual. For the poll, ISO 9001 or TS 16949 is the subject.

Our quality manual is around 40 pages maybe actully a few more than that - however I have many pages that were left blank intentionally to ensure that the sections lined up for easy revision and replacement. Most of our policies are one to three pages so there may be a blank page 2 or a blank page 4 depending on the policy ending on an odd numbered page. :bonk:

Our manual contains two systems QMS & EMS.
Index - 1
Scope - 2
Policy - 2
Document Master List - 2
Top level flow chart - 9

Total 16 pages

With QS it was close to 100. At the start of TS2 it was approximately 50.

Ours is currently in the 50 page range. As we upgrade from TS'99 to TS'02 (this year) we hope to cut that in half or better, basically following the format Sam outlined.

Bill

Nine pages here, covering:

QMS, ISO9001:2000
EMS, ISO14001:1996
H&S, Not certified.
We went for the most basic manual possible, making the most of ISO9001:2000, clause 4.2.2b:
The organization shall establish and maintain a quality manual that includes
b) the documented procedures established for the quality management system, or reference to them,
It works for us...

/Claes

Here is a link to a one pager

Are there any flowchart type quality manuals available for viewing? (http://elsmar.com/Forums/showthread.php?t=8140)

5 pages

Includes TS2, 9001:2000, 14001:1996.

Could be less but I have management responsibility in it.

Chris

Would it be to much to ask you to post it here?

Would it be to much to ask you to post it here?


Howard,

When I have mastered that trick I will !!

It is for a plastic injection moulding company.

I still have your e-mail add, so I will send a copy of the previous '8' page manual to you.

Chris

If I have done this correctly my last issue of manual is attached to this post. :D

It is for a Plastic Injection moulding company in the UK and is 8 pages. As stated earlier it has now become 5 pages.

Comments?

Why don't put manual and procedures together. 1+1(2 in 1)<2(a manual and procedures).

Liuyy

Why don't put manual and procedures together?
That is certainly an option, but in our case it would create a very bulky manual... If your system is not too extensive however, that may be a good idea. Fortunately the standard allows us to go either way here.

/Claes

Why don't put manual and procedures together. 1+1(2 in 1)<2(a manual and procedures).

Liuyy

Been there and done that in the past.

With the new manual the policy statements are removed, and these were the last of the 'Live' parts of the manual.

The procedures, the mandatory 7, are live and I do not/will not update the manual at every instance of an improvement or change.

I tend to find the manual is only wheeled out for audits, the procedures are totally visible and are where they need to be.

If you wish to put the procedures in the manual then please do so.

Chris

First, we developed a 10-page Quality Manual for TS2 Certification and the local CB auditor came for the document review. The auditor "shot" us down and wrote a 35 observations for not adressing each and every additional TS2 clauses and requirements. She was not happy with wafer thin and skin of the teeth quality manual.

So we have to re-write the QM and now it is a good as ISO 9001:1987 versions adopting and adapting every clauses and requirements of the TS2. So it is now some 60-pages QM.

All these while, we are suppose to go for less documentation but these auditors in Malaysia never learn. They are ol' chips of the block and still wanting their ways.

Does the IATF ever audited them and ask whether they insisted the organization to write 60-pages QM.? NO, no & no!!! Yet we still have to obligated to the local CB auditors.

Perhaps, these SIRIM auditors should be re-trained!

Silverhawk,
Did you justify your manual application and outlay.
I've assisted the development and compilations of manuals and, I have been in some heated arguements (Unfortunately) with Registrar auditors who, insisted that their particular interpretations be held as gospel. Well, there are times when, you just have to stand firm if you are convinced beyond a doubt that you are within the limits of the requirements of the ISO/TS standards.
It seems to me that you just rolled over in submission to your registrar auditor.
Wallace.

First, we developed a 10-page Quality Manual for TS2 Certification and the local CB auditor came for the document review. The auditor "shot" us down and wrote a 35 observations for not adressing each and every additional TS2 clauses and requirements.I know little to nothing about TS, but I'll assume that the requirement for the QM is similar to that of ISO9001:2000. If so, she's skating on thin ice... If she won't be reasonable, maybe a quiet word with her superiors would be in order?

Concerning the 35 observations: That is exceedingly poor practice whatever standard may be concerned. One observation would have been enough. They all covered the same alleged problem, right?

So it is now some 60-pages QM.And what a fat lot of good that'll do... :rolleyes:

Perhaps, these SIRIM auditors should be re-trained! That would seem to be appropriate...

/Claes

Hi Claves & Wallance,

It is refreshing but my management decided to go with the auditor's opionion and to address every single time of the TS2 requirement. We shall do this according to 4.2.1; 4.3; 5.2- 5.6; 6.2.2.2; - 8.2; 8.5; 8.6 each and every single requirement that spelled out in the TS2 have been addrssed in our 60-page Quality Manual.

Some of the 35 observations for QM are as follows :-

(1) 4.2.2 Inputs and outputs of each QMS process should be clearly determined.
(2) 5.4.1 Qualioty objectives established at relevant function and levels should be formally documented.
(3) 6.2.2.a Competency needed for personnel performing work affecting product quality objective should be clearly determined.
(4) 6.2.2.4 Employee motivation and empowerment processes should be clearly addressed.
(5) 7.4.1.2 Suppliers shall be thrid party registered to ISO 9001:2000 by an accredited thrid party certification body (unless otherwise specified by the customer).
(6) 8.2.2.2 Manufacturing auidt methods was not effectively establioshed.
(7) 8.2.2.3 Product audit did not cover packaging and labelling of products. Product audit method should be improved e.g traceability of records.
(8) 7.6.1 MSA methods were not clearly addressed.
(9) 7.6.3.1 Standard requirement for calibration lab. was not clearly addressed.
(10) 7.1.2 Acceptance level for attribute data sampling was not zero defects.

These are some 10 observations issued during document review of quality manual and not the on-site certification audit.

In other words, the auditors wanted us to address all the fine words of the TS2 requirements and now we have a 60-page QM which the auditors are happy and proud with not NOT us.

I have send email to the superior of auditor and have yet to hear anything from him...
:mad:

I can see why you're rather perturbed Silverhawk.
When I see this happen though, I have to ask questions regarding the genesis of your particular quality manual.
Was there a steering group involved in the development and compilation of the manual.?
Did it go through a review (PDSA) review process before being issued as a final draft?
Were the folk involved in the manual development and compilation aware of and understand the requirements of the standard in use?
I understand your angst yet, You may learn from this experience by tracing back the history of your development and compilation of the manual along with those involved, using the experience as a continual improvement benchmark.
Wallace.

I remember having some similar problems with a Registrar on an ISO 9000 certification. Your first reaction is normally that you have to do what the Registrar says or you get your certification pulled. It actually takes some work on both the registered party and the registrar to get to that point.

I was fortunate in that my quality director was a President of a Registrar company prior to joining where I worked. She agreed with my position and our corrective action response was that what we were doing was appropriate and management had decided to make no changes. The primary contact for the Registrar did call me, reviewed the position and agreed that his auditor was incorrect.

One advice that I would give is that all registrars should have an appeal process for challenging audit findings. They are also registered so they have a complaint/corrective action system that requires them to respond. You may want to contact them about how their process works since it should be documented.

Bill Pflanz

I've used the one page example posted earlier as the basis of our Quality Manual (actually a tri-fold legal sheet printed on both sides). We have a preassessment in the middle of April, I can't wait to see if our Auditor accepts it. It contains:
1. (front of "brochure") - QMS Scope - taken directly from our certificate, and the doc#, rev level and date of the manual.
2. (inner fold) - Quality Policy and Objectives (signed by Quality Manager and General Manger)
3. (back) - History of the Company
4. (inside) - Processes and their interactions (including the required procedures) and a short blurb about the exclusion (we exclude product design)

We may use it as a sales tool in the future.

This seems to cover everything that the Standard requires, and I have had it reviewed by a couple of certified Auditors with great approval from them...

Can you post your manual here for viewing Mustang?
Wallace.

Wallace,
Here it is, names removed to protect the so-called innocent...

note: unfotrunately I had to remove some of the 'pretty stuff" i.e.: Background photos of our building on the first page and the inside of the plant on the second page. They made the file too large, even zipped.

Looks great Mustang. :applause:
Wallace. ;)

Wallace,
Here it is, names removed to protect the so-called innocent...

note: unfotrunately I had to remove some of the 'pretty stuff" i.e.: Background photos of our building on the first page and the inside of the plant on the second page. They made the file too large, even zipped.


Maybe I am not getting the complete file but there were only two pages when i opened it?

Now I am feeling old. Has the ISO 9000 world changed so much that only 2 pages are needed for a quality manual? My first experience at an ISO 9000 registration was in 1990. Most of the registrations were in non-US sites. There is no way that the British Standards Institute, our registrar, would have accepted that type of quality manual. Even our customers that were requiring a quality manual would have not accepted a 2 page manual back then.

The quality manual was used as a guide for customers, employees and external auditors to provide a summary of what and how the quality management system works. I guess that is no longer the way it is done.

Bill Pflanz
An Old ISO Guy

This is from a year or two ago, as an FYI:

How do you structure your QA (QMS) Manual? A Historical Discussion (http://Elsmar.com/Forums/showthread.php?t=2713)

More Food for Thought!

Our manual have near 60 pages., but I understand Im messing the manual adding process characterization on it. Each process characterization have 2,5 pages and we have 18 process.

Any way to reduce size of process description?When ISO9001 says "reference to docs", I can interprete it as "a list of documents will be found in the documents master list" and nothing more?

Summary to date: See Attachment

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

Marc, I just saw this old reply from you in another thread. In that Manual, when you say XXXXX Map you are making reference to some flowchart?

Yes. Did flow charts years and years ago. Sometimes a company called them maps. Same basic thing.

Thanks, Wallace.

ISO GUY: It is technically two pages, but it is printed on one legal size sheet printed front (page 1) and back (page 2) and folded into three parts with page 2 being on the inside. It will look like a brochure.

The quality manual was used as a guide for customers, employees and external auditors to provide a summary of what and how the quality management system works. I guess that is no longer the way it is done.

Bill Pflanz
An Old ISO Guy


Bill, I believe that I have met the requirements you listed above. I find, in reality, most people are not interested in the nitty-gritty details of everything, and the manual provides them a roadmap on where to go to find the specific detail they are looking for. My goal is to make the manual something people will actually use for something other than to prop up a wonky table leg.

There is no way that the British Standards Institute, our registrar, would have accepted that type of quality manual. Even our customers that were requiring a quality manual would have not accepted a 2 page manual back then.

The quality manual was used as a guide for customers, employees and external auditors to provide a summary of what and how the quality management system works. I guess that is no longer the way it is done.

Bill Pflanz
An Old ISO Guy

That was one of the problems with 9K94...too much documentation!

I'd accept a 2 page manual if the necessary material was adequately covered (I'm a BSI Auditor of sorts)

The type of manual required today can serve as a guide if its format and content coincides with requirements.

p.s. Nice to see you here Bill :)

I have browsed the various posts on this topic and forgive me if I am mistaken, but has anyone so far defined the objective of a quality manual in the context of ISO/TS 16949:2002?

It seems to me that size is only an issue if that is part of the acceptance criteria. If its a document to show customers then its not a document to train employees. If its a document to train employees it might not be a document to analyse processes and improve their performance - so it seems to me that size depends upon who the stakeholders are and what requirements they expect it to fulfill. I would have thought a quality manual to bear such a title had to inform, instruct and perhaps guide people in the achievement of quality. :confused:

Thanks, Wallace.

ISO GUY: It is technically two pages, but it is printed on one legal size sheet printed front (page 1) and back (page 2) and folded into three parts with page 2 being on the inside. It will look like a brochure.


I still must be missing something, I do not see where you have addrssed any of the requirements for 9001:2000 or where to go to find this information?????

I would have thought a quality manual to bear such a title had to inform, instruct and perhaps guide people in the achievement of quality. :confused:

:agree1: When I first started in the ISO 9000 world, the quality manual was used to inform, instruct and guide people. The people could be customers, suppliers, and employees. It was used as a roadmap to describe how management had implemented their management system.

For us, the quality manual had its roots in the quality audits that were done by our customers and pre-dated the ISO 9000 efforts. The customer auditors wanted to have a document that defined how quality was managed. Complaint and corrective action systems, quality metrics, specifications etc. were described in the manual. Interestingly, ISO 9000 caused us to write more policies and procedures since not much else was documented.

Bill Pflanz
An older and trying to get wiser ISO guy

Hi Bill
Before ISO people did things because they worked - after ISO, people do things because ISO or ISO auditors tell them to. But the requirement in ISO 9001 for a quality manual is not there for auditors, its there surely as a vehicle to carry the specification of the system (At least that is what ISO 9000 clause 3.7.4 says) So its similar to a System Spec for a Guided Missile System that defines the system characteristics and refers to all lower level specs and drawings, handbooks, user guides etc - enough to build, test, install, operate and maintain the system. Why can't quality manuals be like this - full of useful information. In addition there is a glossy brochure of the Missile System that is for potential customers.

If we are obsessed with size one solution is to create an Exposition (Call it a quality manual if you want) but all this does is provide a response to IS 9001, TS 16949 etc. It is of no use except to auditors and purchasers seeking assurance of certification. Now is that what the Manager in Post 1 wanted or did he want a document that was useful to the people he employed?

But before we go and participate in the poll on this thread, perhaps each of us has a different perception of the objectives the QM is supposed to achieve making the poll results invalid- its like comparing apples and pears

Now I am feeling old. Has the ISO 9000 world changed so much that only 2 pages are needed for a quality manual? My first experience at an ISO 9000 registration was in 1990. Most of the registrations were in non-US sites. There is no way that the British Standards Institute, our registrar, would have accepted that type of quality manual. Even our customers that were requiring a quality manual would have not accepted a 2 page manual back then.

The quality manual was used as a guide for customers, employees and external auditors to provide a summary of what and how the quality management system works. I guess that is no longer the way it is done.

Bill Pflanz
An Old ISO Guy

But they did. 4.2.2 of ISO 9001:2000 and 4.2 of ISO 9004:2000

But they did. 4.2.2 of ISO 9001:2000 and 4.2 of ISO 9004:2000

Sam,

Help me out here. I dusted off my old copy of the ISO 9004:1987 Guidelines. That standard defined that the primary purpose of a quality manual is:

"to provide an adequate description of the quality management system while serving as a permanent reference in the implementation and maintenance of that system".

The quality manual would then be supported by procedures and work instructions. The fun part of the standards was defining the word "adequate". Sometimes the auditor did not always agree on your definition.

Since I am not active in ISO 9000 anymore, I decided to order the new standards so I could look at them myself. Until I get it could you summarize (without violating copyright laws) what is in the standard as the requirement for a quality manual and the definition of it?

:thanx: Bill

Bill,

ISO9001:2000 requires a Quality Manual.

This manual to include:-

Scope of the QMS (and details of any exclusions)
Documented procedures, or reference to them
A description of the interaction of the processes with the QMS.

The fact that mine is for 14001 as well, is referred to a Management Systems Manual, and is the signpost to the whole system.

We communicate the Quality and Environmental 'ethic' to our staff via handbooks.

Things are less regimented today. You may like what you see in the standard. Then again....

Sam,

Help me out here. I dusted off my old copy of the ISO 9004:1987 Guidelines. That standard defined that the primary purpose of a quality manual is:

"to provide an adequate description of the quality management system while serving as a permanent reference in the implementation and maintenance of that system".

The quality manual would then be supported by procedures and work instructions. The fun part of the standards was defining the word "adequate". Sometimes the auditor did not always agree on your definition.

Since I am not active in ISO 9000 anymore, I decided to order the new standards so I could look at them myself. Until I get it could you summarize (without violating copyright laws) what is in the standard as the requirement for a quality manual and the definition of it?

:thanx: Bill

A quality manaual shall include
- The scope of the quality management system, including details of and justification for any exclusions,

No more than a paragraph

- the documented procedures established for the QMS, or reference to them,

List of procedures, no more than one page

- a description of the interaction between the processes of the QMS.

A top level flow chart of customer oriented processes,
one page,or
A tabular listing of customer oriented processes

Bill,

ISO9001:2000 requires a Quality Manual.

This manual to include:-

Scope of the QMS (and details of any exclusions)
Documented procedures, or reference to them
A description of the interaction of the processes with the QMS.

The fact that mine is for 14001 as well, is referred to a Management Systems Manual, and is the signpost to the whole system.

We communicate the Quality and Environmental 'ethic' to our staff via handbooks.

Things are less regimented today. You may like what you see in the standard. Then again....

Interestingly, it doesn't mention WHY it is required. We see no point in a separate manual (if a customer wants to know that you are certified, a copy of the certificate seems to be enough). We define the Management System as a set of flowcharted process definitions, with reference to documents in the Document Register. You can have a front page with the scope, exclusions etc, then you are straight into "how you run the business". Process Groupings, process numbering and sub-process references within the mani processes show the sequence and interaction.

Interestingly, it doesn't mention WHY it is required.

I find it interesting how quality manuals have evolved over the years. If there is someone else who has a long history with quality manuals, I would like to hear their perspective on the changes. As Peter noted, why have the quality manual at all.

Over the years, I have learned not to question workers on why they are doing something since the response is normally that is how they have always done it. When you quiz them more about the original reason you sometimes find out the original problem that was being addressed is no longer valid. As noted in my first posting, our quality manual was done to satisfy customer audits. The audits, usually conducted by the customer's purchasing group, was only a day or two and the quality manual helped to facilitate the review of the quality management system so it was conducted efficiently. As more customers wanted these visits, it was more critical to make them efficient since it was taken time away from plant operations and probably not adding customer value.

One of the benefits that was normally listed for ISO registration was the reduction in the number of customers coming in to review the quality system.
The intent was to spend less time on the audits and more face time with the customer on specific customer issues.

Bill Pflanz

It is interesting to me the many perspectives there are to how a "quality manual" is understood.

The old veterans remember (pre-ISO) the large manuals that described how each department and process met the customer's requirements. There were many customers, and each had their own unique requirements. The quality manuals were often a collection of all of the procedures and work instructions followed.

The newbies (and the vets that change with the times) tend to see less as best. Write the minimum number of pages to satisfy the standard. Then describe your processes (procedures) using flowcharts. The new "process oriented" ISO related standards allow for, and accomodate this methodology because it does not require a clause by clause audit.

However, The "looser" or "thinner" you get, the more likely the fine points (requirements) in the standard will drop out of the system whem revisions are made. There may be no comprehensive "fire wall".

Two things must be considered when creating a QMS. 1) It must cover every element of every customer standard, including the ISO related ones. Otherwise, you are not in compliance - even if you don't get caught. 2) Users (that is, all employees) must have available ONLY WHAT THEY NEED to get their job done right (i.e. flowchart, work instruction, checklist, etc.); they do not need to know (or even have finger tip access to) all of the customer's requirements.

It is for those two reasons that I have tried to implement our QMS as follows: I have a 35 page Quality Manual that covers all the customer requirements, explaining in detail how, as a matter of policy or principle, we meet those requirements. To support it are the basic flowcharts, instructions, and documents the workforce USES daily (we have only 13 flowcharts and 7 work instructions). If any documentation is not used, it is useless. When changes are made, they are checked against the fire-wall (Quality Manual) to ensure nothing is left out or dropped.

To illustrate: the Quality Manual is like a home insurance policy - it contains all the details, but is generally only used for reference when needed (like when you have a fire). Procedures (e.g. flowcharts) are like your personal instructions for checking and changing the batteries on the smoke alarm, making sure the sump pump is working, or changing furnace filters.

So, to make a short story long, It seems best to have the bulk of the detail in the seldom referred to Quality Manual, and ONLY ENOUGH procedures to help employees get the job done right. As an aside, the more skilled and competent the employees, the fewer instructions are needed.

IMHO, Pre-ISO and up until recently, the Quality Manual was used as a Marketing/Sales tool. It was generic enough to be able to give to customer so that they see you do in fact have a Quality System (At least on paper). It really was the back bone of the system. The procedures and related work instructions really formed the meat of the real system.

We are TS16949 registered, my manual is 6 pages long. COP's are an appendix to the manual that is 6 pages long. Our regristrar loved it. Our customers like it. Our sales office uses it as a "selling" device.

Our sales office uses it as a "selling" device.Great. I think that's the way it should be used.

/Claes

I still must be missing something, I do not see where you have addrssed any of the requirements for 9001:2000 or where to go to find this information?????

Note: I am referring to ISO/TS 16949, but I believe these are the same requirements as in 9001:2000...

4.2.2 Quality Manual
a. Scope - right column on page 1 (front flap when folded), Exclusions - bottome line on page 2 (inside page when folded)
b. documented procedures - referenced on page 2 (not clear on the example I posted, but they are listed as boxes just like the processes)
c. Interaction of processes - incomplete on the example I showed, but it will be similar to what is on page 2

I also cover one of 4.2.1 General Documentation Requirements
a. Quality Policy and Objectives - left column on page 1 (inside flap when folded)

I have included a brief history of the company (center column on page 1, back when folded), therefore making the document a little more personal, as well as a tool for sales

Does that clear up the confusion?

:lmao: Just to let everyone know, our Registrar Auditor was here last week to do a preassessment audit. He was talking about how one of his clients "managed" to get his Quality Manual down to 7 pages.... then I showed him my brochure (attached in an earlier post). He liked it! He reviewed it, and stated that it meets all of the requirements of the Standard. So, that means I squeezed a quality manual onto a two-sided sheet of legal paper. 4 pages, if you count the three columns on one side separately, and one of those is a history of our company, which isn't a requirement.

Mustang...that's awsome! :applause: Great job and vision.
Who was the Registrar that approved it?

Thanks! Thanks to whoever (I think it was Cari) posted the original example. I just wish I could have posted the complete document, with the photos and everything...

Our Registrar company is QMI.

Not I. I can't remember who either. :confused:

I've finally found the link. It was in this thread:

http://elsmar.com/Forums/showthread.php?t=8140

So, my thanks should have gone out to Laura M. :thanx:

...So, my thanks should have gone out to Laura M. :thanx:

Well that's not surprising at all - she rocks!

Also see: How BIG is Your Quality Manual? Now that I have your attention, Big = # of Pages (http://Elsmar.com/Forums/showthread.php?t=6908)

Our corporate European headquarters dont have a paper manual. Only an electronic version in the form of a powerpoint document which is stuffed with hyperlinks to other pages and documents.

In answer to the original question, I suggest you give your boss what he wants by taking the first four pages of the manual and chuck the rest in the bin.





Just a slightly flippant answer.

Elsewhere in the Cove I have posted a 40 page reguritation of the TS2 standard with our scope, quality policy, and reference to the Quality Assurance Procedures. The regurigitation serves as the "description of the interaction between the processes of the quality management system".

Also, a 13 page manual that starts with scope, QP and a list of QAPs, plus an 11"x17" flow chart that looks like the Process Approach in section 0.2 of 9k2k. The flow chart is supposed to be the interaction of the QAPs.

Here's my take: The regurgitation is simple to do, it's only 20 sheets, double-sided, and it's bullet-proof against whatever thing drags itself through your door and calls itself an auditor. It makes their job easier.

I really like the concept of the single-digit-pages manual and it should be able to pass a registration audit. However, not all auditors are as reasonable and logical as Randy, so you must be prepared to thoroughly explain your manual, the interactions AND defend your position against the other kind. I kind of like the challenge presented; your management may want to avoid unnecessary complications.

...AND defend your position...
Key quote. No doubt about it.

QUOTE by Icy Mountain ...AND defend your position...
Key quote. No doubt about it.Amen! Often, as suggested by Icy Mountain, many choose to save their energy for other battles and "regurgitate" a typical QManual that makes life easy for an outside auditor. I do not blame anyone for taking the easy path on this issue of making life easy for an auditor. It is easy enough to put the intelligent stuff like flow charts ONLY in the Procedures and Work Instructions, while leaving the QManual the "same old same old."

My earlier posted manual is now 4 pages and has been accepted by our chosen registrar for TS2. This was during a gap (chasm in places) analysis

He was delighted to find I (we) had spent the time to consider what was useful and what the manual was for.

Perhaps I am lucky ?

He was delighted to find I (we) had spent the time to consider what was useful and what the manual was for.

Perhaps I am lucky ?Good for you. :agree1: You seem to have found an auditor who uses his grey matter. Besides, he should be glad that you're considering the use and usefulness of the thing instead of just going through the motions.

/Claes

I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragragh or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

The reality is, it depends on the organization......your organization.

There are advantages to larger and smaller manuals. A smaller one can refer to a different procedure for almost every requirement, which has the benefit of being able to change one part without a full-blown QM change. A small organization may find the larger version useful, as there are less procedures to keep track of, which makes it simpler.

Finding the happy middle ground is the trick.

Hershal

First Page of Manual shall contain Scope of QMS, Defination and Abbrivations
Second Page shall have Quality Policy
Third Page would be dedicated to Process & Process Interaction Chart/Map
& Fourth would be of Reference of your Quality System Procdures Or else Fourth would be Flow Charts of Five Processes.(Do you remember Control of Documents, Control of Records, CA and PA, Control of Non Conforming Products).

Manoj

Neither Quality nor Environmental policies are in the manual.

They are on the works noticeboards where they can be seen at all times.

I could make it 3 pages if I removed the personnel structure!!

Four pages?! It might be possible if you use the smallest font imaginable & 11x17 sheets of paper...

Four pages?! It might be possible if you use the smallest font imaginable & 11x17 sheets of paper...Hello Lori, and welcome to the Cove:bigwave:

Actually, you don't have to go to such extremes. Our Manual is all of seven pages, covering not only Quality, but also Environment & H&S as well as policies.

ISO9001:2000, clause 4.2.2b allows you to refer to the documented procedures rather than including them in the manual. That leaves scope and interaction of processes...

Disclaimer: That kind of slim manual suits our needs, but does not necessarily suit others... For instance, many small companies choose to include all documented procedures in the manual and have nothing more. Both extremes are perfectly acceptable as far as the requirements in the standard are concened.

It is your manual. :read:

/Claes

Four pages?! It might be possible if you use the smallest font imaginable & 11x17 sheets of paper...

I did it on one two-sided 8.5"x14" (legal size) sheet folded like a brochure, 10-pt text...
Here are the details:

TS-16949 Requirements and location in our manual:
4.2.2 Quality Manual
a. Scope - right column on page 1 (front flap when folded), Exclusions - bottome line on page 2 (inside page when folded)
b. documented procedures - referenced on page 2
c. Interaction of processes - page 2 (master overview flowchart of all processes and required procedures)

I also cover one of 4.2.1 General Documentation Requirements
a. Quality Policy and Objectives - left column on page 1 (inside flap when folded)

I have also included a brief history of the company (center column on page 1, back when folded), therefore making the document a little more personal, as well as a tool for sales

We have been recommended for TS16949 certification, so it has passed muster...

Our manual is an electronic manual. Basically, we have a main (home) page that has links to all policies, procedures, forms, flow charts etc. If I were to print it all out, it would be nearly 100 pages.
I like the idea of a brochure format though.
Thanks for the replies - I'm enlightened.
:thanx:

Our manual is an electronic manual. Basically, we have a main (home) page that has links to all policies, procedures, forms, flow charts etc. If I were to print it all out, it would be nearly 100 pages.
I like the idea of a brochure format though.
Thanks for the replies - I'm enlightened.
:thanx:

What I described was our "Quality Manual" as required by ISO/TS... I also have the master process flow as an electronic image on our intranet, and all someone has to do is click on the box that represents the process and the individual process map opens. Then I have a master document index on the intranet that contains all forms and work instructions, which is searchable (by number, type or title) and linked to the document itself. Mine would be well over 100 pages if everything were printed out (and old management used to require it....). The nice thing is, the requirement has few necessary items, so the actual "manual" can be done simply and efficiently. There is nothing that states everything else needs to be included. That is simply a business choice a company would make if it works for them. I have structured our system to not need all of that detail in printed format, just the basic stuff. It's useful that way (the brochure) when customers ask for a copy, which they sometimes do. We did at one point include everything, but it caused "information overload", where there was so much stuff, no one would look for what they needed in it.

If you have any questions about what I've done, please let me know.

What I described was our "Quality Manual" as required by ISO/TS... I also have the master process flow as an electronic image on our intranet, and all someone has to do is click on the box that represents the process and the individual process map opens. Then I have a master document index on the intranet that contains all forms and work instructions, which is searchable (by number, type or title) and linked to the document itself. Mine would be well over 100 pages if everything were printed out (and old management used to require it....). The nice thing is, the requirement has few necessary items, so the actual "manual" can be done simply and efficiently. There is nothing that states everything else needs to be included. That is simply a business choice a company would make if it works for them. I have structured our system to not need all of that detail in printed format, just the basic stuff. It's useful that way (the brochure) when customers ask for a copy, which they sometimes do. We did at one point include everything, but it caused "information overload", where there was so much stuff, no one would look for what they needed in it.

If you have any questions about what I've done, please let me know.All this makes perfect sense under the current interpretations of ISO9k2k - which emphasizes "customer-centric" and adaptability to conditions.

Here is a direct quote from the opening paragraph of ISO9001:2000. The bold face blue print emphasis is mine.

Introduction

0.1 General


The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.

Now it seems that some Registrar Auditors need to be reminded of this...

I just got back from ISO/TS16949 Class at AIAG.

Our manual will be 1 page. :eek:

Go ahead ask me how. :biglaugh:

I'll bite....

How?

Under 4.2.2 There are only 3 requirements for the 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 exclusions. (exclusions would be product design, or maybe service.)

* b) the documented procedures established for the quality management system, or reference to them, and (Process map, with supporting processes-if you would like a sample let me know)

* c) description of the interactions between the processes of the quality management system. (That would be your supporting processes- It does not say to to define each interaction.)

Think outside the box (This is nothing like QS - Do not read more into it then what is there. If you have a matrix that is well self explanatory it can also be your procedure.)


Our quality manual will be a poster hung several places in the plant. The big book idea for us is over! Will be doing matrix, turtle diagrams and posters for the whole requirments.

If anyone gets a chance to take the QS to TS transition class with AIAG it was well worth it!!!!!!

So it's a poster. That works. Mine is one two-sided sheet, but I have a little extra fluff in for sales' use. I used a bulletin board in the plant to display the turtles and their interactions, so we are on the same track, I think. Good work!

I'm going to be a contrarian here and suggest that the boss is on the right track. I just helped a company through ISO 123485 and with the support of the external auditors went for a very abbreviated QM. The current thinking with new ISO 9000 especially is that the QM is a staement of principles and objectives and a summary of the business and what it does, with reference to where the detail of the system can be found. That can be as genereic as a statement to the effect of the suystem is controlled by Procdures and WIs (as identified in a separate index) maintained by the Quality Manager.

Thjis way you get a positive document, which is essentially a corporate CV, with no concerns about confidentiality and if you make it look good is an effective bit of marketing literature.

Arthur

I've audited a company that supplied a 6 page Q manual (and 2 of those were cover pages). Within the 4 remaining pages were the hyperlinks to all the detail. Only problem was that the Q-manual could only be reviewed on-site and was entirely electronic. It was a good Q-system. Familiarity and implementation was excellent.

Section 4.2.1 NOTE 3 states: "The documentation can be in any form or type of medium", so they are technically in compliance. That sure leaves it pretty wide open if someone wanted to be creative.... How about a Quality Manual set to music? Or a mural? Or carved onto the sides of a cube? Hmmm... now my "frustrated Artist" side is working...

Ours is electronic, I only put together the paper Brochure because so many customers (and our auditor) wanted a copy (not to mention, it satisfied the frustrated artist for a bit). Internally we access everything through a master process map on the Intranet (click on the box, and the process opens).

If theirs is totally electronic, what do they do if someone requests a copy?

Why not e-mail the QM if it is all electronic and someone wants a copy? This would beat the time it takes to mail a hardcopy -- even by Fed Ex!

Or burn it on CD?

Or copy to a floppy?

Why not e-mail the QM if it is all electronic and someone wants a copy? This would beat the time it takes to mail a hardcopy -- even by Fed Ex!

Or burn it on CD?

Or copy to a floppy?Certainly!
A needed dose of common sense, Mike!

The possible problems with that would be you may need to email all of the linked documents as well. If there are lots, it would overload most email systems.

I need to work some bugs out of my printable version to make it emailable. I have lots of graphics in it, so it is a 2 meg .pdf file... 5 meg in Visio.

The possible problems with that would be you may need to email all of the linked documents as well. If there are lots, it would overload most email systems.

I need to work some bugs out of my printable version to make it emailable. I have lots of graphics in it, so it is a 2 meg .pdf file... 5 meg in Visio.In my opinion, you are mixing apples and oranges - the linked documents would most likely be from the next lower levels of documents (Procedures, Work Instructions, etc.) which are not normally delivered with most Quality Manuals, but are only included by reference.

If you have "interactive" graphics - such as clicking on a box in a flow chart brings up details of that segment of the process, then you are talking about having the entire QMS on line. (not a bad idea, incidentally) The entire QMS is not necessarily laid out for everyone who has a copy of the Quality Manual, so everyone would not necessarily have access permission to every link in the top level document (I can envision some Work Instructions being trade secrets.)

Therefore, Mike S's idea of CD or even DVD begins to make sense for those who need a copy of the entire QMS - certainly much easier and inexpensive to create a CD or DVD (you could even have animation) than print hard copies of hundreds of color graphics. In extreme cases, where revisions and additions to components of the QMS are frequent, the entire thing could be put up in a virtual private network on the internet, password protected. As always, individual work stations which need up-to-date copies of Work Instructions, etc. could have those delivered separately in whatever medium (electronic, paper, video) is most convenient for worker at the station to use.

Just my two cents as I wake up from a much-needed nap.

Why not e-mail the QM if it is all electronic and someone wants a copy? This would beat the time it takes to mail a hardcopy -- even by Fed Ex!

Or burn it on CD?

Or copy to a floppy?

Mike, :agree1:

Our travelling sales reps carry all of our specs, data sheets, QM and necessary forms on a CD. We categorise them by colour. They may have a red CD and the next time one of the docs changes we issue them a new CD (Blue for example). They know to destroy the RED one or return it to me for disposal.

What I described was our "Quality Manual" as required by ISO/TS... I also have the master process flow as an electronic image on our intranet, and all someone has to do is click on the box that represents the process and the individual process map opens. Then I have a master document index on the intranet that contains all forms and work instructions, which is searchable (by number, type or title) and linked to the document itself. Mine would be well over 100 pages if everything were printed out (and old management used to require it....). The nice thing is, the requirement has few necessary items, so the actual "manual" can be done simply and efficiently. There is nothing that states everything else needs to be included. That is simply a business choice a company would make if it works for them. I have structured our system to not need all of that detail in printed format, just the basic stuff. It's useful that way (the brochure) when customers ask for a copy, which they sometimes do. We did at one point include everything, but it caused "information overload", where there was so much stuff, no one would look for what they needed in it.

If you have any questions about what I've done, please let me know.

Hello sir :) ,

I am very glad to see you in this posting. I have some query regarding the ISO. As per ISO i started working on Procedures, i will work on all ISO related topics, but i am not getting the implement part.

Let me clear you, there are certain things have to incorporate as per ISO requirements. But i am confused how to incorporate those things in my company. As per ISO it is very essentail to maintain records, but there is only department maintaining records, remaining departments not yet started. I already informed them about the ISO requirements, but they are showing resistance.

Please tell me how to train my people about ISO requirements.

Thanks & Regards
Yugender. K
ISO Quality Department
IIC Systems Pvt. Ltd.

Four-page quality manual is very possible. The My companies actual quality manual has 5 pages with cover page and revision page. Because we are AS9100 Registered we had to also list our operational procedures in it and then added a cross-reference list because we elected to maintain the old 20-element format.

Manual breaks down to the following:

Page One: Cover Page.

Page Two:
 Scope
 Quality Policy
 Corporate Profile
 General (description and interrelationship of QMS)

Page Three:

 Contains the QMS Model with our process titles inserted (Figure 1 of AS9100B). Sub list of processes, ether by title or in flow chart form and QMS exclusions

Page Four

Bullet point definitions of four primary processes: management, resources, product realization and metrics and improvement.

Page Five

 Revision Page.

Page 6 to 10

 Index of our operational procedures and work instructions


Page 11 to 14

 Operational procedures cross-reference to AS9100B and other imposed QMS requirements.


One question asked is why we maintained the old 20-element format and our answer is quite simple:

 Employees are familiar with format
 Customers sill imposes and audit to the older standards
 We manufacture to differing business sectors that have imposed ISO, TL, TS and AS QMS requirements (all in deferring formats)

We just had a TS 16949 surveillance audit. Our auditors said that best practice is 4 pages for a TS 16949 Quality Manual.

What bothers me is that this discussion is based upon number of pages. Do we care about functionality and purpose or the number of pages that an external auditor is suggesting?

I care about functionality which is affected by number of pages for sure. People generally not read long documents (or postings :-) ).

I think we need to discuss effectiveness and efficiency and not number of pages.

By the way, looking at the requirements in TS 16949, a quality manual can be 4 pages. All you need is a scope and exclusions statement, a reference to documented procedures, and a description of the interaction between processes. This is... all you need if it effectively and efficiently meets your busness requirements.

Regards, Dirk

Here is the published guideline regarding documentation for ISO 9001:2000.

Regards, Dirk

Just counted and mine is and even 40 pages including TOC and cover. That includes enbeded graphics and one form. It's divided into a Forward and 4 chapters, with some white on the last page of each chapter.

Hi,

We also had similar requirement from our head. Our manual has around 45 pages.

However after lot of discussion and once we convinced him that it is not possible to fit in all necessary contents in 4 pages. Then he told us the purpose which was that all employees should be able to carry it and should act as quick QMS reference for them.

We decided to publish one small qulity handbook (Quick reference book). The handbook that will contain some quick references for all employees. (paper size A4). The contents were quality policy, Organisation of QMS and some details about applicability of processes to various teams. etc....

Definitely that cannot be termed as quality manual. But we need to look into the purpose of having 4 page manual and can decide what we can do.

Regards,

"We decided to publish one small qulity handbook (Quick reference book). The handbook that will contain some quick references for all employees. (paper size A4). The contents were quality policy, Organisation of QMS and some details about applicability of processes to various teams. etc....

Definitely that cannot be termed as quality manual. But we need to look into the purpose of having 4 page manual and can decide what we can do."

Sure it can! All you need to add is the Scope of your QMS, and you are all set! All that is required for a QM is:
1. The scope of the QMS including exclusions.
2. The documented procedures, or reference to them.
3. A description of the interaction of processes.

Technically, you could fit all the requirements on one page. #2 & #3 can be covered in a master process flow, which includes references to procedures, and the scope is typed across the bottom.

The manual itself does not need to include the details of every process and procedure. Some companies choose to include them, but it is not required. In our system, the processes and procedures exist as independent documents, which makes keeping track of updates much easier. I don't have to update the manual revision level (and reprint and redistribute it) every time someone tweaks a process.

Hope this helps!

Definitely that cannot be termed as quality manual. Oh, yes it can... I agree with Mustang. The "or reference to them" part in particular, is the key...

/Claes

Hi All,

This thread has slowed down a bit in recent times. Does anyone else wnat to share their Quality manual? You can delete the reference to your company and we can all comment and make suggestions. I think we are all striving for the same thing when it comes to QMs. Make it readable whilst ensuring that it meets the company's needs and those of the standard. It is a bit of a balancing act but the cove is the place to find the help. Don't be shy...let it all hang out.

I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragragh or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

The quality manual is not a document for the auditors. It is a document that shows the policy of an organization relating to quality and quality management systems. Presently my company has a manual that is only 16 pages long but that does not say anything. I will be revising it to be more meaningful. It should be presentable to the customers and they should get an insght of the working of an organization.

Dear Amjadrana,

The Quality Manual is a document for the auditors!
The document you described is Quality Policy and it is a part of Quality Manual.

Deamonn

Dear Amjadrana,

The Quality Manual is a document for the auditors!
The document you described is Quality Policy and it is a part of Quality Manual.

Deamonn
No, no, no, no and no.

Quality manuals should not be developed with auditors in mind. The primary users and readers of an organization's quality manual should be the employees, customers and suppliers.

The purpose of establishing a quality management system is to help a company improve its systems effectively. The management system can be verified and audited by a third party but it's sole purpose is to improve the internal working of an organization. Quality manual is an important part of the quality management system. Instead of having a quality manual that does not help an organization, it is better not to have any quality manual at all. The auditors would also like to see an effective quality manual that works for an organization.

The quality manual should describe the company, its working, policy, important objectives and what is does to improve the quality of its products and services. It should be a document that can be presented to other interested parties like vendors, customers.

Registrars and auditors interpret QMS differently. That is my opinion and I hope that I will be able to contribute to this forum.

No, no, no, no and no.

Quality manuals should not be developed with auditors in mind. The primary users and readers of an organization's quality manual should be the employees, customers and suppliers.

What documents are developed with auditors in mind?

What documents are developed with auditors in mind?
In my opinion, NO DOCUMENTS are created with auditors in mind. If the document doesn't fit your business model, it should not be created. If your business model does NOT include the "required documents" to meet a Standard, you should be questioning WHY you are trying to shoehorn your operation to fit a Standard.

Practically speaking, if you want to do business with customers which require your organization to be registered to a specific Standard, all documents required to meet that Standard are really "customer requirements" and NOT "auditor requirements."

It's a tough dilemma. Many supplier organizations are victims of "customer extortion." Only the supplier can decide whether to submit to the extortion or do business elsewhere.

What documents are developed with auditors in mind?

According to some covers, the only documents that are really important for the external auditors are the checks your accounts payable dept. write to cover their invoices....http://elsmar.com/Forums/images/smilies/lmao.gif

Sorry, but I could not resist.

On a serious note, Good external auditors understand that whatever system the organization developed to complywith a Standard, such as ISO 9001:2000, has to work for them (the organization) They are the ones deploying and "living" the system, day in, day out.
So, external auditors have to assess if the system developed by the organization satisfies the applicable stanadrd(s), but the organization MUST NOT develop any document with the auditor in mind, but the actual USERS of the document/process.
Good auditors adapt, learn and assess a multitude of management systems. Bad auditors are inflexible and "demand" things to "please" them, rather than assess effectiveness of the system at hand.

I just had an auditor tell a client that they "had" to have a statement in their quality manual regarding infrastructure and work environment. This org is small, and had documentation in both weekly minutes and an annual meeting of what their next plans are for the facility. The auditor refused to accept that. The president says - let's take a walk, I'll show you what we do to maintain the facility and machinery. The auditor said, "the only allowable exclusions are in Section 7. By not addressing it in words, you have treated it like an exclusion. There are no elements that you can't address without written words. Do me a favor, just paraphrase the standard and for infrastructure and work environment where is says 'you shall' write 'we do.' While you're at it, reorganize your manual, and number it to meet the standard."

He absolutely would not accept that the facility addressed work environment and infrastructure. He did not say - 'how do you feel this requirement has been addressed?' When they tried to get him to discuss it, he got very defensive, and said, 'you can't throw meeting notes at me to show me a requirement is met.' When they said we believe that physically we have addressed the intent of this ISO element - his response was that it was a matter of opinion. The frustrating part is its easier to 'conform' to his 'opinion' than appeal. Any comments?

Single comment: Bummer!

Single question: Appeal to whom? auditor's manager? registrar's top management? In my opinion, simple phone call and email might get you resolution you need; if not, you may be persuaded to "suck it up" this time, but vow to change registrars for next time.

My opinion is that if you can show how it is addressed and provide evidence of meeting the "Shall" that should satisfy the audit requirement. This is what we were taught in the RAB accredited Lead Auditor course for ISO9001/TS16949. After all, anyone can state in the QM, but that does not porvide objective evidence the requirement has been satisfied.

I just had an auditor tell a client that they "had" to have a statement in their quality manual regarding infrastructure and work environment.
I disagree with the auditor statement. Remember, the auditor can not dream/create their own requirements. When it comes to the MINIMUM content of a quality manual, ISO 9001:2000 requires:
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 exclusions (see 1.2),
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.



A minimalist approach to a quality manual could be satisfied in a couple of pages. I am not inferring that this should be the approach to take, but, back to the case in question, ask (POLITELY) your auditor where is the requirement that the manual must include what he wants?

Man....I hope I am doing this right....I have been following along in Elsmar cove for some time now....excellent resource for all types of info and I would like to contribute...but have never done this before....hope this gets out there :( .

My opinion is the same as other peoples....that if you can show how it is addressed (documented) and provide objective evidence....in what ever form that may be.... of meeting the "Shall" that should satisfy the audit requirement.

Sounds like your auditor was having a REAL bad day!

Oh we asked all right. He went to the standard an read out loud to us Section 4.1 with emphasis on "....establish, DOCUMENT, implement...." and SEction 4.2.1 "documents needed by the organization....."
Then he read Section 6.2 (in its entirety), out loud, indicating it was a non-excludable requirement. We indicated that we didn't exclude it, it was accomodated my discussing in our management meeting what we did to maintain these 2 items.

He was an old style 1994 auditor - spent more time pouring through procedures than asking questions. Unfortunately I had calmed many of this organizations fears of ISO, and an auditor with this attitude made them comment "this is what we were afraid of." As it turns out one of the unique ways we addressed the standard in their quality manual was by putting a matrix in the appendix of their manual listing the ISO requirements and the internal documents that addressed it. For Infrastructure and Work Environment we referenced the Management Meeting minutes. That's when he said "you can't throw minutes in front of me to prove you meet a requirement. That's not acceptable."

What can an org do when they know they are right, but the more they question the auditor he was displaying extreme aggrivation and raising his voice to the point of the org worrying if they are going to get recommended for registration or not.

What can an org do when they know they are right, but the more they question the auditor he was displaying extreme aggrivation and raising his voice to the point of the org worrying if they are going to get recommended for registration or not.
Not only you can, but you SHOULD escalate this to the Registrar. This is NOT the kind of relationship you want to develop. If you look at the official ISO Interpretations, the documents developed by the ISO advisory group on good audit practices and the ISO 9000:2000 support documents they all support your position.
To give in now, without a fight, just because it is easier to "fix it than fight it, would send the wrong message to the organization, imho.
We know that we have to be selective about the fights we fight, but this one should not take more than a phone call. Obviously, it seems to me that auditor re-assignement is in order for you. Good luck.

The auditor said, "the only allowable exclusions are in Section 7. By not addressing it in words, you have treated it like an exclusion. There are no elements that you can't address without written words. Do me a favor, just paraphrase the standard and for infrastructure and work environment where is says 'you shall' write 'we do.' While you're at it, reorganize your manual, and number it to meet the standard." Which proves that he has no idea what he is talking about. That man is definitely unfit for auditing duty. I would put my foot down in this case, because you cannot let the auditor run the place, you already have staff to do that. Particularly not when he is w-r-o-n-g. Besides, who knows what he'll come up with next?

/Claes

If it was my company, I absolutely would. Being the consultant, I can't really take this on without their consent. Wish there was a way. They were so concerned about getting registered. I'm just working on them to push for a different auditor at this point.

[QUOTE=Laura M]I just had an auditor tell a client that they "had" to have a statement in their quality manual regarding infrastructure and work environment.

The president says - let's take a walk, I'll show you what we do to maintain the facility and machinery.

The auditor said, ".... Do me a favor, just paraphrase the standard and for infrastructure and work environment where is says 'you shall' write 'we do.' While you'r at it, reorganize your manual, and number it to meet the standard."

Keep the President - lose the auditor!

Not many Presidents are operating at that level of understanding.

Sadly, too many auditors are at his level.

You know, there is an ad-hoc group of people working under the auspices of the TC-176 developing material to assist adequate auditing techniques. The material is available at http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/138403/3541460/customview.html?func=ll&objId=3541460&objAction=browse&sort=name.

One of the documents developed is titled: "How to add value during the audit process" and it is available at http://isotc.iso.org/livelink/livelink/3553372/APG-HowtoAddValue.doc?func=doc.Fetch&nodeid=3553372 .

One of the litmus tests in order to check if a finding is adding value to the organization, is the question:
"...Will the solution proposed by the organization in response to negative findings be useful? . . ."
I am curious if you were to ask this auditor how much better the organization in question would be, after they revise the manual to include what he wants, what his response would be....

?????
Is it the auditors job to find out if the "finding" is adding value to the organization ?

It depends. Some of us do.

Others think that they belong to a special kind of supplier category and don't have to be concerned about adding value to their customer's business.

?????
Is it the auditors job to find out if the "finding" is adding value to the organization ?

One of the things I was taught was to explain the "impact" of the nonconformance to the auditee. This accomplishes two things. First, it shows the auditee that the auditor is not just trying to find things. Secondly, it assists the auditee in determining appropriate resources to apply to the corrective action. If all an auditor is interested in crossed “t”s or dotted “i”s, then showing the impact is quite difficult.

Also, most nonconformances discovered are already known by the auditee. They were just hoping they would not get caught. Explaining the impact might also get the auditees to start thinking along the same line. They might actually begin to fix things when they discover them, and not wait for the audit.

I agree with you Dave

But we get into this discussion about "the scope" and the difference between consulting and auditing


It’s the auditors job to audit per 19011 and that’s it. This whole concept of “value-added auditing” sounds like marketing ploy.


"Others think that they belong to a special kind of supplier category and don't have to be concerned about adding value to their customer's business."

????? please elaborate...

How can so much drivel be generated by so many people whilst taking away so much value from what common sense has to offer....but then, if common sense prevailed there wouldn't be any of this nonsense and none of you would have 'Quality' jobs, I wonder if there is a connection.....?

Please can you moderate your tone
There is no need to be offensive.
Please respect other peoples attitude as you wish them to respect yours.

Mr. Fast One,

Please keep in mind that there is a wide variety of folks visiting this forum, from "newbies" just starting out (or thrown into a "quality" position) to extremely knowledgeable and experienced people with as much or more credibility than yourself. Most of the veterans from this site kindly assist the newer ones in such a way that they maintain their dignity.

If there is something specific that you feel is "drivel", please expalin what that is, and your better alternative. In thay way each of us will benefit from your knowledge.

You seem to have a lot of disdain for Quality practitioners, yet your profile says you are a Quality Manager yourself. Hmmm? At least you were honest in the "introductions" thread where you stated that something that sets you apart from the rest is being "self-obsessed" and "arrogant".

Common sense tells us that professionals have more success when they avoid berating their peers. I don't want to argue, just please, keep your comments respectful. Thanks.

Mr. Fast One,

Please keep in mind that there is a wide variety of folks visiting this forum, from "newbies" just starting out (or thrown into a "quality" position) to extremely knowledgeable and experienced people with as much or more credibility than yourself. Most of the veterans from this site kindly assist the newer ones in such a way that they maintain their dignity.

If there is something specific that you feel is "drivel", please expalin what that is, and your better alternative. In thay way each of us will benefit from your knowledge.

You seem to have a lot of disdain for Quality practitioners, yet your profile says you are a Quality Manager yourself. Hmmm? At least you were honest in the "introductions" thread where you stated that something that sets you apart from the rest is being "self-obsessed" and "arrogant".

Common sense tells us that professionals have more success when they avoid berating their peers. I don't want to argue, just please, keep your comments respectful. Thanks.

It's not "Mr", it's "The".......

....but then, if common sense prevailed there wouldn't be any of this nonsense and none of you would have 'Quality' jobs, I wonder if there is a connection.....?

Of course this is just the assumption that the lack of common sense is the only cause of process variation. Sometimes "exact knowledge", or certain experience is what is necessary to solve quality issues. Even if everyone used "common sense", I think my job would still be quite secure. :thanx:

No, it is not the correct way. Quality Manual is a kind of directive from the Top Management about the way the company has to function. This is, however, subject to the dictats of the ISO 9001:2000 Standards. Therefore, such brevity won't help the working of the organisation adopting it.

:confused:

No, it is not the correct way. Quality Manual is a kind of directive from the Top Management about the way the company has to function. This is, however, subject to the dictats of the ISO 9001:2000 Standards. Therefore, such brevity won't help the working of the organisation adopting it. Very good point! You make two distinctions that most folks don't see. One is the "why" of the Quality Manual. As you say it "is a kind of directive from Top Management about the way the company has to function." The Quality Manual sets the direction of the organization and its QMS. There is also the "what" of the Quality Manual. The standard has specific requirements. I can write a one-page quality manual that meets the technical specifications of the standard, but it could very well be functionally useless. On the other hand I could write a Quality Manual that is just what the organization needs, but still might not meet the standard.

Of course this is just the assumption that the lack of common sense is the only cause of process variation. Sometimes "exact knowledge", or certain experience is what is necessary to solve quality issues. Even if everyone used "common sense", I think my job would still be quite secure. :thanx:

No assumptions, just facts that must be considered within the design and design actions taken to stop them happening. Unfortunately with this 'theory' goes the unwritten 'Quality' rule that this type of work is not primary to the design but is secondary, hence 'Quality practioners' who must perform these activities, so giving no positive value to the customer, therefore, yes, your job is secure....

No assumptions, just facts that must be considered within the design and design actions taken to stop them happening. Unfortunately with this 'theory' goes the unwritten 'Quality' rule that this type of work is not primary to the design but is secondary, hence 'Quality practioners' who must perform these activities, so giving no positive value to the customer, therefore, yes, your job is secure....

Interesting..... There is no way you can design all of the variation out of a process. The FMEA process can identify some of the potential issues, but even then, I doubt many final RPNs will come out a "1". So, it is inevitable that nonconforming product will be created. When we add in the human influence (process operators/management) into the process....

In a perfect world (academia), it would be possible to eliminate the need for quality departments and functions. However, I’ve been around long enough to know we will never get close to that perfect world. There are too many sources of variation available. Now, not being specifically “trained” in quality, I do not know what the “unwritten Quality rule” is. I do know that while “quality” functions are not value added, neither is payroll, and janitorial services. But if people don’t get paid, the toilets don’t flush, and the customers leave because of quality issues, all value added functions cease.

I think Fast just wants to pick a fight out of boredom.

Hey Mike & db, Fast One sounds a bit like another member from across the big pond. Can you say Nosmo King????

Brilliant minds do think alike!!! Or is that birdbrains of a feather or something?

Refer back to 4.2.2 it list the three requirements that the quality manual must include to meet the standard. You may consider flow charts. Although with that being said our manual is 22 pages. Your quality manual is probably the first document that a new customer would requst to review. In reality it shows good business ethics and committment up front. Good Luck

Refer back to 4.2.2 it list the three requirements that the quality manual must include to meet the standard. You may consider flow charts. Although with that being said our manual is 22 pages. Your quality manual is probably the first document that a new customer would requst to review. In reality it shows good business ethics and committment up front. Good Luck

As a potential customer of Avery Weigh-Tronix (http://www.wtxweb.com/) I reviewed their quality manual as part of my supplier approval process today. They have an ISO 9001:2000 QMS, and their manual is one of the very best I've seen.

Click on this link to view their *** DEAD LINK REMOVED *** 'On Line Master Version'.

"shows good business ethics and commitment up front." :applause: 11 Page Quality Manual

I was particularly impressed with how sparingly the matrix on page 11 was presented. Yes. The manual in this instance does not need to repeat all the language of the Standard and certainly makes itself well-understood without bogging down in details about procedures. Most especially, it does not contain a lot of self-serving language about a "mission to solve all the problems in the known universe."

Thanks for bringing it to our attention!

When I met with Quality Goddess on Wednesday, she stunned me by citing the EXACT number of "shalls" in ISO9001:2000. Do you know the number? I certainly didn't.

When I met with Quality Goddess on Wednesday, she stunned me by citing the EXACT number of "shalls" in ISO9001:2000. Do you know the number? I certainly didn't.

Having been pulled from among the rank and file of my organizations QA pool three years ago to write our documented ISO9001:2000 QMS, I counted all the ' shalls ' knowing that would be a good place to begin manual construction. IMO the ' shalls ' are the skeletal structure to any manual that must demonstrate compliance/conformance.

Admittedly, until your recent challenge the actual count of ' shalls ' was a trivia question for which I had misplaced the answer.

However after review on the Standard, I believe there are exactly 136 ' shall ' statements within the ISO9001:2000 Standard, not counting the 1 in the standards ' forward ' and the 1 in the pdf disclaimer if you have the electronic version.

As a potential customer of Avery Weigh-Tronix (http://www.wtxweb.com/) I reviewed their quality manual as part of my supplier approval process today. They have an ISO 9001:2000 QMS, and their manual is one of the very best I've seen.

I guess I'll throw some Lighter fluid on the already lit BBQ (it is Spring and I do so love that Whoomp sound!)

I don't like systems that follow the numbering and section structure of ISO. They cause me intense pain, similar to the burns caused from spraying lighter fluid on the BBQ.

For sure they have something that meets the requirements of ISO, but I wonder if it is integrated into day to day use.

I suspect that people call it the "ISO system". And I have a bad feeling that they'll get around to that "quality stuff" after they get their "real job" done.

Well, perhaps it works well for them...and at the end of the day that's all that matters.

My goal in life has been to bury ISO so deep in the real business system that no one knows it exists. Stealth quality, BMS not QMS.

Our manual has a process map and calls out our procedures...3 pages...the ISO requirements are hidden in an x-ref that no one but me and the registrar ever sees.

I just got tired of people doing things because "ISO" or "Quality" said so...and I stopped it.

We got people to define their business process as they actually did it. Then I did an ISO gap analysis. In most cases we had to add very few things.

Out to the deck with my lighter can I go!

I guess I'll throw some Lighter fluid on the already lit BBQ (it is Spring and I do so love that Whoomp sound!)

I don't like systems that follow the numbering and section structure of ISO. They cause me intense pain, similar to the burns caused from spraying lighter fluid on the BBQ.

For sure they have something that meets the requirements of ISO, but I wonder if it is integrated into day to day use.

I suspect that people call it the "ISO system". And I have a bad feeling that they'll get around to that "quality stuff" after they get their "real job" done.

Well, perhaps it works well for them...and at the end of the day that's all that matters.

My goal in life has been to bury ISO so deep in the real business system that no one knows it exists. Stealth quality, BMS not QMS.

Our manual has a process map and calls out our procedures...3 pages...the ISO requirements are hidden in an x-ref that no one but me and the registrar ever sees.

I just got tired of people doing things because "ISO" or "Quality" said so...and I stopped it.

We got people to define their business process as they actually did it. Then I did an ISO gap analysis. In most cases we had to add very few things.

Out to the deck with my lighter can I go!


Caster, is the BBQ ready yet? Your post is greatly appreciated.

I'm in the Aircraft Maintenance (service) industry...deeply entrenched in regulatory compliance...our ISO9001:2000 QMS (did I just here a whoomp sound) is just over one year old. Top Executive Management decided to get certification because a BIG customer required it.

I know...I know, the prophets of doom have already whispered in my ear, the failure rate statistics of organizations who's primary reason for seeking registration is because the customer said so.

If you were a fly on the wall observing from within our organization, it wouldn't take you long to conclude that implementation of a QMS (Whoomp sound) is a giant leap. I am as sincere about 'total' quality' as the rest of my company has always been well focused on total 'airworthiness' matters.

Gap analysis showed need for much improvement (how do you eat an elephant?), when ISO9001:2000 went on line. I do what I can, and vow to do more once I get my resume polished up a bit. Until then, on a daily basis I put much enthusiasm and energy into our quality management system (Whoomp...whoomp...whoomp). Somebody please call the fire department. :frust:

I just got tired of people doing things because "ISO" or "Quality" said so...and I stopped it.

We got people to define their business process as they actually did it. Then I did an ISO gap analysis. In most cases we had to add very few things.Brilliant... I really like that.:agree1: Now go easy on that lighter fluid... I think i can see the fireballs from over here...:mg:

/Claes

I don't like systems that follow the numbering and section structure of ISO. They cause me intense pain, similar to the burns caused from spraying lighter fluid on the BBQ.

For sure they have something that meets the requirements of ISO, but I wonder if it is integrated into day to day use.

I feel the same way. My manual is written to our service requiments and not in ISO format. It's organized better, flows better, and is more user friendly.

HOWEVER, in order to make it through our annual audits, I had to develop what turned out to be a three-column, 19-page, cross reference grid to reference where to go in my 22-page Quality Manual to find our ISO elements. And, quite frankly, I'm getting a little tired of maintaining those two documents, so I am probably going to bite the bullet and re-do the QM into ISO order later this year. Should be LOTS of fun! :bonk:

Umm, I gotta ask. Do you need the cross reference to make it through the audit, or has the auditor asked for it?

HOWEVER, in order to make it through our annual audits, I had to develop what turned out to be a three-column, 19-page, cross reference grid to reference where to go in my 22-page Quality Manual to find our ISO elements.:bonk:

Yikes!! :mg:

I feel the same way. My manual is written to our service requiments and not in ISO format. It's organized better, flows better, and is more user friendly.

HOWEVER, in order to make it through our annual audits, I had to develop what turned out to be a three-column, 19-page, cross reference grid to reference where to go in my 22-page Quality Manual to find our ISO elements. And, quite frankly, I'm getting a little tired of maintaining those two documents, so I am probably going to bite the bullet and re-do the QM into ISO order later this year. Should be LOTS of fun! :bonk:

...And I was considering the idea of throwing my ISO QM (by clause) formatted documents into Caster's BBQ Pit. That fireball would have been a sight to see. Actually, I am researching ways to make my ISO QS more user friendly and meaningful. Without my consent or input, my company retained a consultant to build my manuals. My marching orders were to assist him. :bonk: Well, the consultant convinced the hierarchy in my company that he'd guaranee we'd pass document review.

Well, the consultant opened a can of ISO9000 and just added water. We passed document reveiw with several minors and observations, and received certification on first surveillance assessment.

At this point in time our QM conforms to the ISO9001:2000 standard but IMO does not add a lot of value to our company's business goals at the moment. I'm sure that our QM will go through a major overhaul prior to ISO renewal.

Well, the consultant convinced the hierarchy in my company that he'd guaranee we'd pass document review.

Well, the consultant opened a can of ISO9000 and just added water. We passed document reveiw with several minors and observations, and received certification on first surveillance assessment.



:yuk: These types of consultants need to be stopped!!!! Worse yet - some of these consultants were created by the auditors that like it that way!!!!!

I'm just wondering if y'all oughtta just use charcoal and lighter fluid for the BBQ and hold-on to the QM's. In my experience, the QM is the document that has the least to do with adding value or helping achieve business goals. It sets minimums that you must do, and shows how you'll meet the ISO requirements, but there is nothing stopping you from exceeding these minimums through changes in your "level 2" and "level 3" documents that are closer to the process. I'd think that unless you were making really major changes and/or your QM was written very "tightly" you would not need to change the QM to make major changes elsewhere.

Am I missing the mark somehow?

HOWEVER, in order to make it through our annual audits, I had to develop what turned out to be a three-column, 19-page, cross reference grid to reference where to go in my 22-page Quality Manual to find our ISO elements.What? Why? Did the auditor pressure you into doing that? I see no such requirement in ISO 9001. Our manual is now dow to seven pages, thanks to heavy use of ISO 9001:2000, clause 4.2.2 b: the documented procedures established for the quality management system, or reference to them, andand we have no such list. And, quite frankly, I'm getting a little tired of maintaining those two documents,I don't blaim you. Let me ask you this: Does that crosslist add any value to anyone, except possibly the external auditor? You may want to get rid of the list instead of rewriting a manual that is organized better, flows better, and is more user friendly than a manual following the ISO order...

Neither ISO 9001 nor your QMS are meant to make the auditors life easier. They are both meant to benefit the users.

/Claes

I believe that quality manual should be concise & to the point. It should not replace the SOPs.
It could be from 8 pages to XYZ depends on the size of the organization & complexity of the activities.

wilsonmm: Let me add the weight (if there is any) of my opinion that my colleagues are right to be appalled that your system seems to be a slave to some auditor rather than a useful and efficient system for you and your organization. If you have the power within the organization, you should discuss this at length with the bosses and determine whether you folks need a long, stern talk with the Registrar management before switching to a different Registrar.

Muleskinner: The consultant who gave you "instant documentation" did exactly what he was paid to do. The management obviously only wanted a "quick and dirty" to appease the customer. (Think of your situation as like Dilbert's - big honkin' manual used as a doorstop - and ignore it while you go about the business of helping your organization stay on track of Quality and adherence to FAA regulation.)

Muleskinner: The consultant who gave you "instant documentation" did exactly what he was paid to do. The management obviously only wanted a "quick and dirty" to appease the customer. (Think of your situation as like Dilbert's - big honkin' manual used as a doorstop - and ignore it while you go about the business of helping your organization stay on track of Quality and adherence to FAA regulation.)

Wes, Thanks! You nailed it. I'm back on track now.

wilsonmm: Let me add the weight (if there is any) of my opinion that my colleagues are right to be appalled that your system seems to be a slave to some auditor rather than a useful and efficient system for you and your organization.


I'm still waiting for Wilsonmm to weight in as to whether the auditor 'required' it to get through the audit, or if he/she needs it. It sounded like 'auditor', but that's not exactly stated as yet. If Wilsonmm needs it, then maybe eventually it can go away as knowledge of the standard increases.

Just to put things in perspective:
While QM of an aerospace company, I HAD to create a similar matrix showing how to correlate sections of my QM with FAA regulations for the FAA inspector who hung mistletoe on his coattail for all of the shops (and FAA coordinators) under his purview.

I had to use Chapstick after each of his visits from so much kissing up. Sometimes, just sometimes, you can be right and still get whipped.

Just to put things in perspective:
While QM of an aerospace company, I HAD to create a similar matrix showing how to correlate sections of my QM with FAA regulations for the FAA inspector who hung mistletoe on his coattail for all of the shops (and FAA coordinators) under his purview.

I had to use Chapstick after each of his visits from so much kissing up. Sometimes, just sometimes, you can be right and still get whipped.


Someone who has been there
Thanks for putting things in perspective.

What? Why? Did the auditor pressure you into doing that? I see no such requirement in ISO 9001. Our manual is now dow to seven pages, thanks to heavy use of ISO 9001:2000, clause 4.2.2 b: and we have no such list. I don't blaim you. Let me ask you this: Does that crosslist add any value to anyone, except possibly the external auditor? You may want to get rid of the list instead of rewriting a manual that is organized better, flows better, and is more user friendly than a manual following the ISO order...

Neither ISO 9001 nor your QMS are meant to make the auditors life easier. They are both meant to benefit the users.

/Claes

Even though our Quality Manual is "only" 22 pages, we have over 1,100 procedures company wide that comprise the total QMS. Many of the ISO required references are found in other documents (e.g. training requirements in the Training Manual, Logistics in the Supply Manual, etc.)

The auditor did NOT require me to create the reference grid. However, he did "suggest" I come up with something to help me locate references more quickly. Our operation is in Florida spread out in about 80 locations in four counties, the auditors are based in Maryland, and they're usually here for only two days to audit half or more of all ISO elements. Time is precious!

The auditor did NOT require me to create the reference grid. However, he did "suggest" I come up with something to help me locate references more quickly. Our operation is in Florida spread out in about 80 locations in four counties, the auditors are based in Maryland, and they're usually here for only two days to audit half or more of all ISO elements. Time is precious!Ah. So you do have use for the list after all... Still, I understand what a chore it must be to keep it updated. But there may be other ways to keep track of references. As an example I bury that information in the document properties (word documents) of our written procedures. A search will then find them if need be.

/Claes

Where is the value in rehashing each element of ISO or QS 9000 in a Quality Manual that no one will read? We are an ISO company so requirements are set in section 4.2.2 which states

Establish a quality manual to describe the quality system, and to document or reference operational procedures. Identify and justify in the Quality manual any exclusions of ISO 9001 requirements.

To meet these requirements we state our Quality Policy and objectives, establish the four tiers of documents required and their purpose (Manual, Procedures, work instructions & records), display a key process map showing how these procedures work together. We also state or inclusions and have an organizational chart.

I feel our biggest problem is the number of procedures (16). I have read that their are only six procedures required to document your quality system (Internal Audits, Corrective Actions, Preventive Actions, Management Responsibility, Nonconforming Product and Documents Control) but I have never seen a QMS set up like that.

I feel our biggest problem is the number of procedures (16). I have read that their are only six procedures required to document your quality system Why is that a problem? It may be that only a small number of documented procedures are directly required, but you are alse required to have documents needed by the organization to ensure the effective planning, operation and control of its processes... (4.2.1d).

/Claes

Compliance. The more you write the harder it is to maintain compliance. Procedures should drill down to who does what. Our Work instructions detail individual how to's. My companies problem is that ISO became a fix all. Everytime a problem occured over the last 15 years some new procedure or work instruction change was made. The distinction between the two were lost and the company ended up with an unmanageable document monster.

For the last two years I have been beating that monster down to a pit bull. We started by creating a 10 page QM. Next we put together a process map detailing how the processes of ISO would cohesively work together. Next we assigned processes owners who could rewrite and revise their documents to simplify. The process owners were also responsibile for training. Next we took out anything that related to associations to specific references this required multiple document changes each time we made one small change and was a consistent audit finding.

We still have some procedures that are more work instructions but I'll get them soon.

My companies problem is that ISO became a fix all. Everytime a problem occured over the last 15 years some new procedure or work instruction change was made. The distinction between the two were lost and the company ended up with an unmanageable document monster.So you are aiming for a lean system? I can relate to that, since we had similar problems. Good luck on your quest :agree:

/Claes

Where is the value in rehashing each element of ISO or QS 9000 in a Quality Manual that no one will read? We are an ISO company so requirements are set in section 4.2.2 which states

Establish a quality manual to describe the quality system, and to document or reference operational procedures. Identify and justify in the Quality manual any exclusions of ISO 9001 requirements.

To meet these requirements we state our Quality Policy and objectives, establish the four tiers of documents required and their purpose (Manual, Procedures, work instructions & records), display a key process map showing how these procedures work together. We also state or inclusions and have an organizational chart.

I feel our biggest problem is the number of procedures (16). I have read that their are only six procedures required to document your quality system (Internal Audits, Corrective Actions, Preventive Actions, Management Responsibility, Nonconforming Product and Documents Control) but I have [never seen a QMS set up like that.]

Perhaps you have never seen a QMS set up like that because it does not make sense. Would that serve much value to runnng your company, other than meeting ISO.

Everyone reads 4.2.c, but 4.2.d is just as important.

Please make the documented system make sense to help you run your business. It should say the thngs you would say if you set up a system without ISO. What kind of forms, instructions and procedures would you write then? For ISO, you should write the same thing. Except, if you committed to meet the ISO requirements, then it would seem those should be in your system too. Otherwise, how do employees know that you agreed to meet those?

I have drawn up draft quality manuals for clients and have had them successfully registered to both ISO 9001:2000 and ISO/TS 16949. I'm amazed that you can write that you do this stuff for customers and registrars. What other manuals get written for everyone else but management? No wonder ISO is in decline! We have to get real about this stuff and stop doing it for the wrong people and the wrong reasons. Do it for the folks who count - your own management team. Sure it's hard to get them to buy in - change is always tough! If it hurts, it's probably the right thing to do!
BTW I attach one of my drafts (just for kicking around) - just as an idea, I know it's not perfect but it sure beats 30 pages!
Andy

I have drawn up draft quality manuals for clients and have had them successfully registered to both ISO 9001:2000 and ISO/TS 16949. I'm amazed that you can write that you do this stuff for customers and registrars. What other manuals get written for everyone else but management? No wonder ISO is in decline! We have to get real about this stuff and stop doing it for the wrong people and the wrong reasons. Do it for the folks who count - your own management team. Sure it's hard to get them to buy in - change is always tough! If it hurts, it's probably the right thing to do!
BTW I attach one of my drafts (just for kicking around) - just as an idea, I know it's not perfect but it sure beats 30 pages!
Andy

Andy, I'm a bit confused. I agree you should write the system for the company and the managers, but your policy manual does not define any policies? It has a nice map and all, but where do you address what you do? It only links to the minimum procedures, and none of the documents 4.2.d calls for.

Would you care to clarify? Thanks.

because I didn't see any need for 'policies'. Where is the need for 'policies'. The draft has a place for a Quality Policy, so which ones are you refering to?
Are you, for example talking about the need to define a policy for each of the requirements of ISO 9001? If so, what benefit to the organization are they? If the TAG's who wrote the standard wanted a policy for each requirement, wouldn't they have defined it in the requirement?
What other documents are you refering to, from 4.2d? This should all be taken care of in lower level (process and sub-process, work instruction types) of documentation, not in the quality manual.
Andy

because I didn't see any need for 'policies'. Where is the need for 'policies'. The draft has a place for a Quality Policy, so which ones are you refering to?
Are you, for example talking about the need to define a policy for each of the requirements of ISO 9001? If so, what benefit to the organization are they? If the TAG's who wrote the standard wanted a policy for each requirement, wouldn't they have defined it in the requirement?
What other documents are you refering to, from 4.2d? This should all be taken care of in lower level (process and sub-process, work instruction types) of documentation, not in the quality manual.
Andy


It seems unclear what the purpose of what the "manual" is there for. The manual is just there to address the requirement to have a manual, but what does it do? By the way, I agree the other documents can be "lower level" though I don't know if TS particularly addresses the old multi level pyramid of documents. I think it regrds them as documents, which is fine.

But, what is the purpose of the manual? It doesn't address very much. There may need to be more in define the interlinks between processes as well. Recent witness auditors have required more detail than that, I am told. ...my two cents...

to descibe the quality management system of the organinzation, inlcuding its scope, etc, the objectives by which its performance is to be measured, detail something about the organization, management 'structure' and so forth. I have yet to see any manual fashioned around the ISO (or similar) requirements to be of any value. These types of manual are normally created by a single person to meet the needs of some outsider, as you say, "Recent witness auditors have required more detail than that, I am told." There we go again! Who are we writing this for? If some external auditor wants more detail, push back is my advice!
Andy

to descibe the quality management system of the organinzation, inlcuding its scope, etc, the objectives by which its performance is to be measured, detail something about the organization, management 'structure' and so forth. I have yet to see any manual fashioned around the ISO (or similar) requirements to be of any value. These types of manual are normally created by a single person to meet the needs of some outsider, as you say, "Recent witness auditors have required more detail than that, I am told." There we go again! Who are we writing this for? If some external auditor wants more detail, push back is my advice!
Andy



I do agree with you in principle, but I may disagree in execution. I think the approach is a little bit thin. Even a lot thin. But, we can disagree on that. I certainly agree that it should be for the company, but I don't leave out the fact it has to be audited as well.

buying into the idea of a smaller, thinner manual. I've got a number of clients who've not got a 'conventional 30 pager'! It's just the way it's introduced to the auditor!
Andy

:argue:

Well, let's see. A title page, table of contents, definitions, and that leaves about one page to describe the management system. Hmm. Maybe your managers need to read the requirements for developing a manual.

Good Luck to you. Obviously they are lacking the commitment to the program, and need to rethink if certification is an option.

dmp

My 4 pager has no problem with meeting 9001, TS and 14001:2004.

I say if you want a huge manual do it.

We put our efforts into the operating side of things, and I for one am not going to re-issue the manual for the ongoing system maintenace that is always required.

Well Good Luck to you with your manual.

Well, let's see. A title page, table of contents, definitions, and that leaves about one page to describe the management system. Hmm. Maybe your managers need to read the requirements for developing a manual.

Good Luck to you. Obviously they are lacking the commitment to the program, and need to rethink if certification is an option.

dmp

Okay, I argue. Forget the cover page and table of contents. With a one page QM, you need neither. The same goes for the definitions. None of the above are required. Looking at the requirements in 4.2.2, a single page QM is possible. But as hjilling asked: "...what is the purpose of the manual? " If the manual is for internal use only, then a one pager may be adequate. If the manual is going to customers and external customers, you will probably need to add a lot. Remember to look at who is using the manual, and for what. If you need more than four pages, either your system must be really complex, you have a lot of non-required information to provide to the outside, or you have a lot of fluff that is probably not requried.

DB - right on. I was just about to reply the same - well stated.

Have been following this thread for awhile and finally decided to add my :2cents: .

After several years of refinement, I have a quality manual template that is only 9 pages and satisfies both ISO 9001:2000 and AS 9100 B requirements for a quality manual.

What adds up is all the supporting documentation which explains how you do what your quality manual says you do.

I bet if I increase the margins and reduce the font I could get it down to 7 or 8 pages.

The manual is the easy part as the standard tells you exactly what needs to be there. It's all that supporting documentation that is the real work because it is different for every business.

JMO

It seems unclear what the purpose of what the "manual" is there for. The manual is just there to address the requirement to have a manual, but what does it do? By the way, I agree the other documents can be "lower level" though I don't know if TS particularly addresses the old multi level pyramid of documents. I think it regrds them as documents, which is fine.

But, what is the purpose of the manual? It doesn't address very much. There may need to be more in define the interlinks between processes as well. Recent witness auditors have required more detail than that, I am told. ...my two cents...

Hjiling has asked the right question "What is the purpose of the manual?". I've seen Quality Manulas used as the main document supplementing procedures and working directly to work instructions which is an older more traditional use requiring additional pages due to content. Ive seen Quality Manuals used as sales pamplets pointing out key aspects of the system that appeal to customer. I've even seen a larger Quality Manual used literally as a door stop (DoD facility). :frust:

If you really belive managers not assigned direct quality responsibility are going to read your manual you are in for disappointment.:(

During an implementation I set up the Quality Manual as a prinicple auditing tool. I provide the traditional org chart, procedures list with a responsibility matrix, a plant map (I hate it when I lose auditors:D ) and a process flow. I provide a uncontrolled copy for auditors use.

The bottom line is determine the use of the manual if your hand cuffed to a standard then make sure it is appleid as required without waste.

from Comcast of all companies!:mg: It includes lots of things which look amazingly like 'policies' and 'procedures' and stuff like that to tell us cable customers what's what with Comcast products and services:agree1:

Maybe my model of a 4 page quality manual wasn't so far off, after all:jawdrop:

Merry Christmas everybody!:bigwave:

Andy

Have been following this thread for awhile and finally decided to add my :2cents: After several years of refinement, I have a quality manual template that is only 9 pages and satisfies both ISO 9001:2000 and AS 9100 B requirements for a quality manual.

The QA office of our business sector will always tell me to "keep it short and simple," but every time they audit us there are always 5-7 suggestions of things that should be added. My current plan is 37 pages in an old format that doesn't relate to ISO. When I redo it next year in ISO format, I'm going to shift a lot from the body of the document into appendixes, but still think it will wind up at least 40 pages long.

hello
i am a consult, i have consulted many companies, most of the quality manual are about 30-40 pages,i think it is normal level,

We just had a TS 16949 surveillance audit. Our auditors said that best practice is 4 pages for a TS 16949 Quality Manual.

What bothers me is that this discussion is based upon number of pages. Do we care about functionality and purpose or the number of pages that an external auditor is suggesting?

I care about functionality which is affected by number of pages for sure. People generally not read long documents (or postings :-) ).

I think we need to discuss effectiveness and efficiency and not number of pages.

By the way, looking at the requirements in TS 16949, a quality manual can be 4 pages. All you need is a scope and exclusions statement, a reference to documented procedures, and a description of the interaction between processes. This is... all you need if it effectively and efficiently meets your busness requirements.

Regards, Dirk

Hello,

Two years ago we went from QS to TS. Our quality manual in the QS time had 80 pages and when we got to TS, we build a pretty efficient process flow that explain it all in only 8 pages. What would made the difference is the number of and the structure of your processes.

Hang on!

Kaliko

Chiming in on this one...

Most of my clients are using a model I developed a few years ago, it's about 5 pages and it's booklet-sized (half-sheet).

It includes the scope statement/exclusions, a blurb about the company, the policy statement, the overview map, and a reference to the next level of docs. Some clients also want other things in there, photos of the product, etc., but I leave that up to them.

I did this because my experience as a consultant taught me that the quality manual was the least used document in the system; this booklet-style manual, when designed well, is an attractive and easy-to-read handbook that can also be used for marketing. Most clients put their registrar's logo on the back after they get registered, and the registrars like that.

I had one auditor/registrar tell me that it was the best design for a manual that he'd ever seen. I don't know about that, but at least it's not a waste of paper anymore -- it only has information that people need, and it's likely to be read by most of the employees.

Perhaps you would be willing to share it with us :thanks:

Most of my clients are using a model I developed a few years ago, it's about 5 pages and it's booklet-sized (half-sheet).


i would like to see a sample too, if possible :thanx:

Add me to the list of those who would love to see it – especially since I’m about to have to re-write our QAPP.

Your statement, “I did this because my experience as a consultant taught me that the quality manual was the least used document in the system; this booklet-style manual, when designed well, is an attractive and easy-to-read handbook…” caught my eye because I’m using the same approach with the least used form in our inventory, the Continuous Improvement Report (CIR).

Since our CIR forms tend to be put in a file and forgotten about, I'm designing a new one as an eye-catching pamphlet that can be put in the workplace and hopefully actually used now and then for improvement suggestions.

To those who asked for an example of the 5-page manual: I promise to post it here later, I'm on the road now and will be home later this week.

I'm happy to share, the approach has worked for me.

OK, I seem to be in the minority, but I'm with your superiors. I'd want no more than 8 - 10 pages max!! Can one? Yes. Not one of the organisations I've got certified have had ones been longer than this. Otherwise it's too wordy. But... what I'm meaning here is the 'high level policy stuff' - if one included procedures as well, it would be more pages (perhaps, oh, say another 20 for a small - med organisation).
The problem may also be that people are using the term 'Quality Manual' to mean different things. I believe the Standard uses it to mean your documented system overall - and these days, that can include intranet/hard copy, whatever. But yes, overall, I'd go with exec - less, not more.

If it was my company, I absolutely would. Being the consultant, I can't really take this on without their consent.
Laura, I empathise totally with your predicament when faced with an obstinate Auditor insisting that stuff has to be in the manual because HE says so - and yes, being the consultant, one can't take it on without their consent. I'd ask for it.
I've been in an almost identical situation on 2 occasions: both times, the auditors were frightful, but for different reasons. One was a little Hitler type, who was steeped in 1994 and when questioned (politely) on any of his pronouncements, took it as a personal offence, and got more & more aggro... and this was only the doc review (precursor to the audit itself). He ended up quite literally yelling at me and the client (MD of the small firm) and insisting that all kinds of things HAD to be in the manual because HE said they had to, and utterly refused to give any specific clause references...

I thought about it long & hard, & then rang the registrar, & spoke 'off the record' to a contact there. Her response clearly indicated that this wasn't the first time there had been a problem. I requested the client's permisison to make a written complaint - and did. But I took care to be very, very objective with the complaint, and to stick carefully to facts only - even got someone else to review the letter before it was sent. That auditor is no longer auditing (and IMO a good thing too). Turns out he'd had a lot of back problems & was in a lot of pain that day, which is some explanation, but still no excuse for his quite appalling behaviour.

The other was dreadful for a different reason - spent more time telling my clients what they should be doing differently (in his opinion) after no more than the most cursory look at their system for the first time; they were already certified. I complained about him too, to the same registrar. And believe it or not, all this happened within the same week!

But the registrar responded quite magnificently - were very concerned, and said that not enough people ever did complain. a/ people don't know they can (whereas consultants do) and b/they worry it'll affect their results.
If auditors keep being allowed to get away with this kind of B if not C grade 'service' they'll go right on doing it.

Bottom line: registrars ain't God. They provide a service, and are paid to do so. But if they have fixed little ideas about Their Version of any Standard, and aren't able, let alone willing, to really look at how different companies have implemented that Standard, then I'd look for either a different Auditor and/or a different Registrar, like one who employs better trained Auditors, with a better outlook.
Cheers
Jane

Kirill, and others,

Loved your examples of short, short manuals. Way to go.
It's actually much, much harder to make something short, than it is to make it long. (Worth reading de Bono's Simplicity on this. One has to understand something really well in order to 'simplify' it.)
Yes, we can all regurgitate the Standard & search & replace 'organization' with 'CompanyName'. But why on earth bother? It adds zippo value to anyone.

Those process maps have a lot of work & thinking behind them. 'Quality' can't be assessed in the number of pages - it's the content that's important, and most of all: does it add value to the organisation and do what it's supposed to do?

I recently moved into the quality management group for the company as the manager for our ISO program. I inherited a 46 page quality manual that simply restated the ISO 9001;2000 standard. In my estimation, maybe 10% of the employees had read the manual because it was dry reading and stated the obvious. If the read rate is that low then what good is the manual. I studied the standard and decided to write a manual that would provide exactly what paragraph 4.2.2 required. When I completed the task I had reduced the manual to 4 pages. The manual has received wide acceptance from management, our customer, and the third party auditor. In speaking with the employees I have found that a large number have read the new manual which to me is a great improvement.

I totally agree with others when they say keep it simple.

I completely disagree with this kind of “catalog” quality manuals.
The Quality Manual has to bring added value to the QMS. It must show all our policies in all the subjects related to our QMS and to the standard (if it’s for registration).
Four or five pages, what for?
It’s better to don’t have one!:mad:

The larger and complete Quality Manual, the shorter (or inexistent) written procedures we must do.
What should be simple are the procedures, not the Manual....

There is no reason to get mad about a difference of opinion.

Would you rather have a 40 - 50 page manual that 95% of the employees have not read or one that is 4 - 5 pages that 95% have read. I see more value in having a manual that is short and understandable that most people will read than having one that restates the standard and adds no value to the employees or the quality management system. The level 2 and 3 documents within the quality management system are the documents that make the company run effectively - not the quality manual itself. Strictly my opinion.

Dear J. Harrison,

I’m not getting mad.:bigwave:
It’s just my opinion as all here are as valid.
The ideal is a Quality Manual that shows what quality means for the organization in all the subjects.
I really don’t like that thing of levels in the quality documentation. In my opinion we must have very well defined, complete and consistent policies written in the Quality Manual.
That’s impossible in a 4 or 5 pages document!
And that’s no manual at all, that’s no more than promotional documents companies use to give their customers – they mean so little to the organization that I can give them to any person...

The issue of having everybody reading and specially understanding the policies written in the Quality Manual, it’s a different story...
Here we have to deal with training. And also in my opinion the QM must be the first item in training anybody into the quality field of any organization.
Lately when I go to any large transnational company for a training course about any quality subject, it’s normal that the quality manager gives me their Quality Manual so that I can be updated with their policies related to Quality. Sometimes they ask me to talk about a subject referred in their Quality Manual. In these cases we are talking of QM with more than 100 pages.

Gentlemen, if you stop a minute and look at the poll results, it might give you a clue. When it comes to a quality manual, one size does not fit all. Different organizations might have different approaches to their quality system.
The one thing I agree with both of you is that quality manuals should not be irrelevant documents. If they don't serve a purpose, something went awry. Unfortunately the brainless approach of regurgitating a standard as a quality manual still proliferates quite abundantly.

I find another, practical reason for keeping the manual short.

The quality procedures and instructions can contain a lot of commercially sensitive information. However - one very useful function for the quality manual is as a form of corporate cv (resume for the americans here ;) ).

If you take the approach of keeping it short, including some well written overview of what the company is about, its product lines, objectives and values (all of which lay the foundations for objectives and associated procedure documents in the system to meet ISO 13485) - then what you get is a document that can be published freely - and given to your customers and potential customers as a marketing tool. You can't do that if its large and includes all sorts of technical detail which you may not wish to disclose to the wider world and which would not make for exciting reading to customers.

Arthur

When it comes to a quality manual, one size does not fit all. Different organizations might have different approaches to their quality system.

Couldn't agree with you more Sidney.

No, one size does not fit all. The 2 keys questions perhaps are: does the manual suit the organisation? Does it achieve the organisation's purpose?

I'd always rather have doco that 95% of people have read than 5%, and I've found that keeping things short, clear and simple go a long, long way toward achieving that.

But what would suit, say, a 10-person consulting business couldn't and wouldn't suit a multinational, global engineering firm with hundreds or thousands of employees. Purpose and audience reigns. In the former, you could have far fewer policies, because 'top management' is infinitely closer to their personnel. In the latter, you have to represent far more things in the written form, and sometimes in quite a lot of detail. Horses for courses... it always comes back to the situation, the purpose and the audience. I'll always stay with my approach of keeping it as short as is possible (note: as is possible) but I wouldn't, for example, be comfortable with anyone approaching even a small construction project without what can be quite a wad of documentation, most of which is entirely necessary!

BUT I also think one can encompass both approaches: for example, give the overview (keeping it simple) at the high level... give more detail only as and when needed. No one wants to read 30 pages, for example, to answer a single basic question. And in these days of online documentation, hypertext, hyperlinks, help files, etc. etc. there's little excuse to require them to do so.

Final point: I wonder if everyone means the same thing by 'quality manual'? Overall, I understand the term to mean the totality of written documentation (whether that be in paper, online, electronic system, maps, flowcharts, etc). But in other emails some people appear to be meaning just the top level manual, what one might call the policy type manual. And at times, that includes some of my own, just to be confusing!!

Final point: I wonder if everyone means the same thing by 'quality manual'? I understand the term to mean the totality of written documentation (whether that be in paper, online, electronic system, maps, flowcharts, etc). But some people appear to be meaning just the top level manual, what one might call the policy type manual.

I think you hit the nail on the head. As I've read this thread, I've been thinking the long manuals probably include alot of the operating procedures, while some of us supporting the short ones, it's strictly the policy manual. The procedures are referenced but not included.

I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragragh or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

this thread was first published in Novemeber 1998. i think that's very interesting since the new ISO 9001 standards are in place.
One thing that I wanna add is that according to ISO 9001:2000. The size of the documentation depends upon the nature of your work & the competence of your personnel.

I still have my opinion:
If the Quality Manual only serves to get registration, the best you have to do, is throw it away!
The QM has to bring added value to the organization.
I’ve made Quality audits in witch I need to ask the auditee some extra information, generally procedures, because the Manual only states a little bit more that the organization’s name...
Any QMS I’ve made, before the audit the Registrar only asks for the QM!
There we can find everything about the Quality System you need to know to prepare the audit.
Of course the size of the Manual depends on the kind of company, but a small company can have a consistent and substantial QM. If it’s well done! :rolleyes:

About the know-how that can be a secret of the organization, I’ve never seen also any secret in any QM..., the place to put “secrets” are specifications or procedures.

I’ve made Quality audits in witch I need to ask the auditee some extra information, generally procedures, because the Manual only states a little bit more that the organization’s name...
Any QMS I’ve made, before the audit the Registrar only asks for the QM!
There we can find everything about the Quality System you need to know to prepare the audit.

This touches slightly on an area that, as long as this thread is becoming, hasn't really been discussed which is the impact an audit can have on the size of the quality manual. My program has been audited six times by ISO auditors. I've never had a non-conformance, but always get 3 to 5 OFIs which usually state "you could be clearer about...." And, in answering each OFI, things are added to the quality manual and it continues to grow in size.

Sure, there have been times we disagreed with the recomendation of the auditor and made no changes, but most often each OFI led to a new paragraph, chart or both, and the manual grows.

I thinks sometimes when an auditor is paid to inspect your program and you pay for his time, travel, lodging and expenses, they feel compelled to report "something" to justify the expense - - and the manual grows.

Just MY opinion.

I thinks sometimes when an auditor is paid to inspect your program and you pay for his time, travel, lodging and expenses, they feel compelled to report "something" to justify the expense - - and the manual grows.



I agree 100%!!!:applause:

I've never had a non-conformance, but always get 3 to 5 OFIs which usually state "you could be clearer about...." And, in answering each OFI, things are added to the quality manual and it continues to grow in size.

Sure, there have been times we disagreed with the recomendation of the auditor and made no changes, but most often each OFI led to a new paragraph, chart or both, and the manual grows.

It's a little hard talking in generalities... although I understand the problem. But before adding anything or increasing size, I'd still ask: does the manual suit the organisation? Does it achieve the organisation's purpose?

Perhaps it might help to to stop thinking of the quality manual as a single entity, and thus ask: does the collection of documentation that sets out/describes/whatever our implemented system suit us? Does it achieve our purpose?

Auditors are human too (other opinions to the contrary notwithstanding ;) I've met good, bad, and ordinary ones, & on a couple of memorable occasions, appalling ones. But no matter which, I personally would not add anything to the system, which includes the manual or any other document, unless I was clear about which section(s) of the Standard the auditor was referencing, and precisely what the lack of clarity was. What's the effect? What is the auditor attempting to achieve? How do they think that making this change will improve things?

Any external auditor is an outsider - meaning they give you an outsider's perspective. This can be very useful or valuable at times. And at other times, not. They are there to test the system, to 'challenge' it, if you like. It's their job.

But OFI or not, you choose what to do about it. And if I had audited an organisation, then returned for a later audit, and followed up, and the client company said, 'well, we considered your point, and this is what we did (eg, asked x managers/personnel... tried it out with 5 new employees, etc etc) and decided it was quite satisfactory/worked well as it is, so we closed it off as not required' then I (& I think any other reasonable auditor) would agree with that.

It's your quality management system, and *your* organisation. Not the auditor's. I do not think it is worthwhile to do things only because the auditor said. In fact, I think it's usually a very bad idea.

Let me add there are other places to add documentation (Procedures, Work Instructions, Records) than in the Quality Manual, which I view as simply an "overview" of the organization's Quality System. While it may be true "the Devil is in the details" - that doesn't mean the details have to be in the Quality Manual.

We are audited by a well respected british accreditor and a lead autitor suggested a 5-6 page manual. I have a copy of doc, will post latter on

We are audited by a well respected british accreditor and a lead autitor suggested a 5-6 page manual. I have a copy of doc, will post latter on

I don’t think that is a good practice the registration lead auditor suggests any method to any organization...
At least I can not do that..., and specially about the way an organization should make their fundamental quality document.
Even when I see those short Quality Manuals, that I generously call “expendable”, I only make comments to my self, even though I would like to ask the owner what’s the use of that...:)

Hi all, brilliant thread this is! Different perspective on QMS manuals:

What I've been missing in this discussion is the form of the QMS manual. I've seen the brochures which were really neat, but I haven't seen powerpoint presentations or webpages or how's about video's with voice over, etc.

The form has got a lot to do with the audience you seek with the QMS manual. Decreasing the number of pages is not the only way to make a QMS manual as lean as possible. I'm working on a powerpoint manual at the moment with lots of graphics and hyperlinks. 20 slides or so, audience are all employees + interested customers.

Anyone with more ideas on the form of the QMS manual?

Hi all, brilliant thread this is! Different perspective on QMS manuals:

What I've been missing in this discussion is the form of the QMS manual. I've seen the brochures which were really neat, but I haven't seen powerpoint presentations or webpages or how's about video's with voice over, etc.

The form has got a lot to do with the audience you seek with the QMS manual. Decreasing the number of pages is not the only way to make a QMS manual as lean as possible. I'm working on a powerpoint manual at the moment with lots of graphics and hyperlinks. 20 slides or so, audience are all employees + interested customers.

Anyone with more ideas on the form of the QMS manual?


The format can be any type of media you want to use, paper, electronic, DVD, Powerpoint, etc...as long as it is accessible to the users. In fact, I would encourage you to use your creativity.

Hi all, brilliant thread this is! Different perspective on QMS manuals:

What I've been missing in this discussion is the form of the QMS manual. I've seen the brochures which were really neat, but I haven't seen powerpoint presentations or webpages or how's about video's with voice over, etc.

The form has got a lot to do with the audience you seek with the QMS manual. Decreasing the number of pages is not the only way to make a QMS manual as lean as possible. I'm working on a powerpoint manual at the moment with lots of graphics and hyperlinks. 20 slides or so, audience are all employees + interested customers.

Anyone with more ideas on the form of the QMS manual?

This sounds unique and interesting. Perhaps you would be willing to share it here on the Cove when completed.

What I've been missing in this discussion is the form of the QMS manual. I've seen the brochures which were really neat, but I haven't seen powerpoint presentations or webpages or how's about video's with voice over, etc.

The form has got a lot to do with the audience you seek with the QMS manual. Decreasing the number of pages is not the only way to make a QMS manual as lean as possible. I'm working on a powerpoint manual at the moment with lots of graphics and hyperlinks. 20 slides or so, audience are all employees + interested customers.

Anyone with more ideas on the form of the QMS manual?

If you publish your system electronically, as it sounds as though you do, why have a "manual" at all? Publish your process definitions and document register, find some software which will let you automatically create job descriptions as a by-product of saying who does what in your processes, and you have covered all the "requirements" for a manual (which I have never understood the need for anyway...)

There is another thread about which flowcharting software people are using - I would suggest that you can benefit from going beyond "just" drawing separate flowcharts to define individual processes, and create an integrated management system to describe how the business is run. That way you can meet individual requirements from the standards almost by default.

To those who asked for an example of the 5-page manual: I promise to post it here later, I'm on the road now and will be home later this week.

I'm happy to share, the approach has worked for me.

I'd like to see the 5 page manual. If you get a chance, can you post it?

If you publish your system electronically, as it sounds as though you do, why have a "manual" at all?

Totally agree with you Peter. I consider the term 'manual' a broad one, and if necessary explain to the auditor that the manual is a virtual one, not a physical entity.

Inexperienced & not very good auditors often prefer what they're familiar with, which I consider is their problem, & reflects badly on them & their employer. A good auditor will welcome the chance to understand how THIS particular organisation has chosen to document its own system, & will be unfazed by a different media used for the doco.

The hard thing for those who haven't seen any examples like that, is that it's usually impossible to demonstrate it to you outsidethe organisation, because it's usually a collection of electronic files/html files/whatever, and not a single thing one can easily 'take away' and post somewhere like here.
The closest I can come is: look at a good help section for something on the web and then imagine what it might be like to present a 'quality manual' like that: to really give people just what they need, quickly and exactly when & where they need it. Magic when it's well designed & presented!

Totally agree with you Peter. I consider the term 'manual' a broad one, and if necessary explain to the auditor that the manual is a virtual one, not a physical entity.

Inexperienced & not very good auditors often prefer what they're familiar with, which I consider is their problem, & reflects badly on them & their employer. A good auditor will welcome the chance to understand how THIS particular organisation has chosen to document its own system, & will be unfazed by a different media used for the doco.

The hard thing for those who haven't seen any examples like that, is that it's usually impossible to demonstrate it to you outsidethe organisation, because it's usually a collection of electronic files/html files/whatever, and not a single thing one can easily 'take away' and post somewhere like here.
The closest I can come is: look at a good help section for something on the web and then imagine what it might be like to present a 'quality manual' like that: to really give people just what they need, quickly and exactly when & where they need it. Magic when it's well designed & presented!
Jane

Agreed. As a matter of interest, have you ever come across an auditor who explains WHY the standard says you must have "a manual" (rather than the standard just listing certain things that you must define)?

Totally agree with you Peter. I consider the term 'manual' a broad one, and if necessary explain to the auditor that the manual is a virtual one, not a physical entity.

Inexperienced & not very good auditors often prefer what they're familiar with, which I consider is their problem, & reflects badly on them & their employer. A good auditor will welcome the chance to understand how THIS particular organisation has chosen to document its own system, & will be unfazed by a different media used for the doco.

The hard thing for those who haven't seen any examples like that, is that it's usually impossible to demonstrate it to you outsidethe organisation, because it's usually a collection of electronic files/html files/whatever, and not a single thing one can easily 'take away' and post somewhere like here.
The closest I can come is: look at a good help section for something on the web and then imagine what it might be like to present a 'quality manual' like that: to really give people just what they need, quickly and exactly when & where they need it. Magic when it's well designed & presented!


In my opinion, a well developed electronic approach is one of the best ways to do the job efficiently and effectively. There may be a few paper pieces here and there where electronic is no accessable, but the rest can view it onscreen. Actually, I see more and more of my clients moving in that direction, and the standard specifically supports the idea it can be any form of media.

Interesting question, Peter. The answer is yes: but only the good ones. But that goes for not just explaining about why a manual is necessary, but being prepared to explain in sensible terms, often tailored to the particular organisation or its field, why any of the elements in the Standard are necessary.

And hjilling, I agree also that electronic can be a great way to go. (But again, it's the old horses for courses. Some documents don't lend themselves well to reading online - some research suggests that people read & process up to 40% slower online.)

Interesting question, Peter. The answer is yes: but only the good ones. But that goes for not just explaining about why a manual is necessary, but being prepared to explain in sensible terms, often tailored to the particular organisation or its field, why any of the elements in the Standard are necessary.
Jane

Interesting reply - and maybe not the one I expected. You see, I don't think that a "manual" SHOULD BE necessary (other than because the standard says it is)! I have no problem saying that certain things need to be defined by any organisation, but why in "a manual"?

What does it mean, anyway? ISO9000:2000 defines it as "a document specifying the quality management system of an organization" - what is listed in 4.2.2 is hardly a "specification", ie "a document stating requirements" (ISO9000). If your system is electronic, then everything is integrated and all the requirements of 4.2.2 are covered by default. If you are still using paper, why list a few bits and pieces separately - unless it suits you?

And hjilling, I agree also that electronic can be a great way to go. (But again, it's the old horses for courses. Some documents don't lend themselves well to reading online - some research suggests that people read & process up to 40% slower online.)
That is why process maps / flowcharts etc work so well online, because you can be much more concise (up to 80%?)

You see, I don't think that a "manual" SHOULD BE necessary (other than because the standard says it is)! I have no problem saying that certain things need to be defined by any organisation, but why in "a manual"?

Oh, I see, I misunderstood a little. Perhaps we're discussing the meaning of 'manual'. I take a reasonably liberal interpretation of it, and have been known to debate the issue, um, quite vigorously, with old-fashioned auditors with a very rigid and IMO now very old-fashioned view of it.

Don't see it as necessarily a single document, nor a paper book ... I take the view that it can be a virtual entity (ie, made up of a number of components) and as we have agreed, in any media.

I definitely see some value in having a documented system, rather than a purely verbal one. But I insist on the documentation being practical, useful, and also IMO it can include systems and applications. For example, one client created a (proprietary) application, originally using VisualBasic, but now migrated to the web, where they have essentially captured all their repeatable processes and procedures into the application itself, as workflow. It works very well for them - and the auditor took the very sane and enlightened view that they certainly didn't need more 'written stuff'. But without seeing it in action, it's almost impossible to believe it's as good as it is. But then, you'd be quite on side with that I imagine, given the nature of what you do.

I think ISO makes the whole notion of the 'quality manual' quite mysterious - perhaps I should vote for simplifying the notion of it in the next.


If your system is electronic, then everything is integrated and all the requirements of 4.2.2 are covered by default.
True - but only provided it's well structured & well designed. It doesn't happen by magic!

That is why process maps / flowcharts etc work so well online, because you can be much more concise (up to 80%?)
Um, sometimes. Is it possible that the nature of your business might influence your opinion somewhat?
The screen is not the page - I've yet to see any screen that could represent a flowchart as clearly and nicely as laser print on good paper... Sometimes, you just end up with not enough screen space to put things on BUT of course you can 'layer' things and jump/hyperlink beautifully.

Overall, though, I suspect we're both probably in strong agreement here. :)

True - but only provided it's well structured & well designed. It doesn't happen by magic! ... Is it possible that the nature of your business might influence your opinion somewhat?
Sorry - you're right. We find that folk can need help to (i) identify their processes, (ii) define a simple structure for their system, (iii) avoid defining things in more detail than they need.


The screen is not the page - I've yet to see any screen that could represent a flowchart as clearly and nicely as laser print on good paper... Sometimes, you just end up with not enough screen space to put things on BUT of course you can 'layer' things and jump/hyperlink beautifully.

Overall, though, I suspect we're both probably in strong agreement here.
It depends on the style you use - I've also seen examples of "awful" process maps (whether that means a map of the system showing all its processes, or a map of an individual process - I tend to use the term for the latter) where the author may have gained some understanding by drawing it, but anyone else thinks that they are looking at a spider's web...

Hi Everyone,

Hope to find all of you in the best of health and spirit.
In my relentless pursuit for quality and development,
attached pls find my humble attempt to make quality work.

Thanking you in advance for sharing your insightful comments, invaluable advice and time.

One look they certainly look too philosophical. Reason being the existing manual were simply missing the plot with so much cuts and pastes.
On top of that, Top management just wanted Certificate on the wall.
I would very much like to give everyone within the organisation and their customers another chance.

If need to, can anyone advice how do I disqualify previous CB?

I strongly belief in morale responsibility in all this.
I hope you can help me make it more practical and effective.

Cheers :thanx:

...

If need to, can anyone advice how do I disqualify previous CB?




If you need to make a change, changing CBs (registrars) is not difficult. If you find a different one you refer to use, the new one has to assume your certificate, then you notify the previous one of the change.

When you have selected the new one, they can explain the change in more detail.

I have aprox 12-15 pages in the QM's I've produced for several of my clients. They have passed muster with UL, DNV and ABS. And they have been accepted by many of the big boys in the oilfield (Shell, Schlumberger, Bp and BHP to name a few.) The Level II and III documents are more detailed. And again this comes down to the assessor. What works for one may not work for the next one from the same CB.

If you are new to this, I have to agree there may be some misunderstanding here. Are they refering to the procedures (Level II) not being any more than 4 pages. Sometimes that can be hard to accomplish depending on the complexity of the process. I have found that the biggest procedure will be the document and record control procedures. But that all depends on if you are writing procedures on every element or if you are combining things. For instance, you can have 1 procedure for 8.5 Improvement which contains continuous improvement and corrective and preventive action or you may have 1 procedure for each element of the clause. Either way is acceptable and it all depends on how much paperwork you want to keep track of.

We have all, at some point, been in your situation Dawn but we are here to help. The internet is a great resource for ISO information and I was really happy to find these wonderful people. I'm flying solo on my first implementation and I don't know what I would do without the Cove.

A four page Quality Manual may be too much! What does the International Standard require in a Quality Manual? ISO 9001:2000, 4.2.2 lists THREE requirements:
1. The Scope of the QMS (a statement usually found on the registration certificate);
2. The documented procedures or, a list; and,
3. A description of the interaction of between the processes of the QMS.

Number 1 is a sentence; number 2 is a list; and, number 3 can be a high level flow chart. Some organizations have managed to include all this on one sheet of "paper" (the procedures are hyperlinks).

If anyone would care to see examples of this, please contact me.

A four page Quality Manual may be too much! What does the International Standard require in a Quality Manual? ISO 9001:2000, 4.2.2 lists THREE requirements:
1. The Scope of the QMS (a statement usually found on the registration certificate);
2. The documented procedures or, a list; and,
3. A description of the interaction of between the processes of the QMS.

Number 1 is a sentence; number 2 is a list; and, number 3 can be a high level flow chart. Some organizations have managed to include all this on one sheet of "paper" (the procedures are hyperlinks).

If anyone would care to see examples of this, please contact me.That's interesting, but the point of a Forum is to put the examples HERE, not drive folks to your website and consulting business, no matter how highly qualified or respected you might be. Call it "courtesy among professionals."

Why don't you reconsider your post and edit it by adding a few examples for us to view HERE?

I'm in a good mood, don't take offense where none is intended.

What does the International Standard require in a Quality Manual?

I don't see how that question is even relevant, frankly, with regard to the size of the manual. Content should be determined by common sense and the needs of the business, not by the minimum requirements.

As you read through this entire thread, you will find that is the exact point - there is no specific requirement other than the three parts of Section 4.2.2

the scope of the QMS + exclusion justification
the procedures or a reference (this does NOT require a list - you can merely refer to them sayiing "we have procedures to >>>"
description of the interaction between QMS processes (lots of ways to describe!)Some folks need more words and some fewer words - the Standard only asks you to use what you need to make the system clear to the most important people reading it - the users!

Ask your superiors "what font size for a 3-4 page quality document?" I think they must be refering to each element in the manual should not exceed 4 pages.
:lol:
Yeah,that is good !
OR,maybe they mean "font size =1",in order to fit to 4 pages.

Hi Everyone,

Hope to find all of you in the best of health and spirit.
In my relentless pursuit for quality and development,
attached pls find my humble attempt to make quality work.

Thanking you in advance for sharing your insightful comments, invaluable advice and time.

One look they certainly look too philosophical. Reason being the existing manual were simply missing the plot with so much cuts and pastes.
On top of that, Top management just wanted Certificate on the wall.
I would very much like to give everyone within the organisation and their customers another chance.

If need to, can anyone advice how do I disqualify previous CB?

I strongly belief in morale responsibility in all this.
I hope you can help me make it more practical and effective.

Cheers :thanx:

I really enjoyed your induction presentation. It was insightful and informative. It was surprising to see someone in Singapore quoting John Maxwell on Leasership. Thanks for sharing!

Doug

Hey, just thought I would try and jump in on this one. Two weeks ago we went through our phase 1 for TS. A week and a half before our top management fired our consultant, and scrapped everything that he had accomplished including our quality manual. They then moved me over from the environmental side to the quality side and told me to write a new manual and to try and get us ready for stage 1. In that week and a half we rewrote the manual, conducted a complete internal audit of the whole system and thought we were ready to go. Then we found out on the day before the audit that our quality Manager turned in his resignation. On the day of the audit we were blindsided by this manager, who told the auditor that not only were the corrective actions from the last audit not closed, he had never even written them up. This was after presenting info to me during the internal audits. It was about that time that the Auditor shut down the audit and said no to Stage 1. Since then I have convinced the management to pursue ISO9001 and then go into TS some time next year. I say all this to bring it around to this point, when the auditor looked at the manual that I had come up with, he asked one question. "Do you feel it contains everything you need?" I said yes, that we use it along with process maps, and he said then it was acceptable. Even though I am still trying to get it smaller. 5920

On the day of the audit we were blindsided by this manager

Don't you just love surprises at audit time? :mg:

I think your manual is pretty good, and I especially like the active voice being used throughout. If you want to do a little paring, I think you can safely eliminate the self-referential 4.2.2; you don't need to say that there's a quality manual in the quality manual.

On the day of the audit we were blindsided by this manager, who told the auditor that not only were the corrective actions from the last audit not closed, he had never even written them up.
Yowza - somebody's disgruntled!:mg:

I agree with Jim - your manual is fine.

Even though I am still trying to get it smaller.
Please don't make it smaller for smaller's sake - make it a usable document for the intended audience.

"The Lord's Prayer has 50 words.
The Ten Commandments have 297 words.
The Constitution of the United States of America has 4,500 words.
Our Company Quality Manual has 10,572 words."

A short & very readable article (http://www.reliableplant.com/article.asp?articleid=3223) about what this guy did about it dropped into my email inbox. I think he definitely had the right idea!

A short & very readable article (http://www.reliableplant.com/article.asp?articleid=3223) about what this guy did about it dropped into my email inbox. I think he definitely had the right idea!
Right, Jane. This guy is making a business out of what we have been writing all along - he has a very clever hook in comparing length to famous and well-known documents.

Hey, just thought I would try and jump in on this one...
<snip>
... when the auditor looked at the manual that I had come up with, he asked one question. "Do you feel it contains everything you need?" I said yes, that we use it along with process maps, and he said then it was acceptable. Even though I am still trying to get it smaller. 5920

You could make it smaller still - by replacing the last 5 pages or so with a simple reference that says something like :

REFERENCE TO DOCUMENTED PROCEDURES ESTABLISHED FOR THE QUALITY MANAGEMENT SYSTEM, QUALITY POLICY, AND QUALITY OBJECTIVES

A full and current list of all Version COntrolled Quality System Documents is contained in the <Document Register Name>.

That way you can keep your index up to date in a controlled manner, but not just have it as a list appended to the Manual. A current print of the document register ccould be supplied tot he auditor ahead of an assessment visit.

By the way this gives you a 3.5 page manual including the cover sheet ;-)

Arthur

I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragraph or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

Hi Dawn,
I am going to flaunt conventional wisdom here as stated in the other posts.
My company has been registered for about ten years and we actually develop software for compliance management systems and I have helped many companies put together and document compliance management systems.
Our manual is 14 pages long currently.
I am a real less is more gal. Our manual includes the following:
1. Quality Policy
2. Scope of Registration statement/copy of certificate
3. A listing of our primary processes, and how and where they touch at a high level.
4. Then we have a page dedicated to each business process individually. This includes the following:
[LIST]
Process Description and flow diagram
Process Responsibilities and resource requirements
Process inputs and outputs
Process validation requirements/ history
Metrics for that process
Links and Reference to Level 2 documentation for that process
The reference to level 2 documents is all I want to maintain. I personally do not want to include level 2 in my manual ( in our system when accessing the manual electronically the reference is also a link that takes you to the most current version of a specific level 2 document/s).
When we were first registered, as is my practice and recommendation I requested the document review of the manual and supporting level 2 documentation be a separate activity in advance of the on site assessment. That way I had a chance to address any changes/omissions/ additions required after the doc review before they showed up on site including assuring that they process flow and employee knowledge matched the final manual and document content.
I have never liked the doc review as part of the on site registration visit.
I simply sent them a CD with the manual and all the supporting level 2 documentation.
[LIST]
Org Chart ( no names just titles and hierarchy)
Controlled distribution list and sign off
Change and revision history
My position, rightly or wrongly, is that the QA Manual is all about painting a conceptual picture of my business as it relates to the standard and responsibilities. I strive to keep that fairly static. I reserve my energy and press for detail and strong change management around my procedures and WIs etc.

I understand, of course, that the manual may need to have more content depending on your industry and the standard involved. I just always strive to keep documents of any kind, brief, pertinent, current and accessible to the people who need the information in that document. I am big on visuals, diagrams and flowcharts and stingy with narrative.
As far as four pages go, honey that isn't a quality manual that is a haiku!
Good luck and moderation in all things!
Regards,
Mary

Hi Dawn,
I am going to flaunt conventional wisdom here as stated in the other posts.
My company has been registered for about ten years and we actually develop software for compliance management systems and I have helped many companies put together and document compliance management systems.
Our manual is 14 pages long currently.
I am a real less is more gal. Our manual includes the following:
1. Quality Policy
2. Scope of Registration statement/copy of certificate
3. A listing of our primary processes, and how and where they touch at a high level.
4. Then we have a page dedicated to each business process individually. This includes the following:
[list]
Process Description and flow diagram
Process Responsibilities and resource requirements
Process inputs and outputs
Process validation requirements/ history
Metrics for that process
Links and Reference to Level 2 documentation for that process
The reference to level 2 documents is all I want to maintain. I personally do not want to include level 2 in my manual ( in our system when accessing the manual electronically the reference is also a link that takes you to the most current version of a specific level 2 document/s).
When we were first registered, as is my practice and recommendation I requested the document review of the manual and supporting level 2 documentation be a separate activity in advance of the on site assessment. That way I had a chance to address any changes/omissions/ additions required after the doc review before they showed up on site including assuring that they process flow and employee knowledge matched the final manual and document content.
I have never liked the doc review as part of the on site registration visit.
I simply sent them a CD with the manual and all the supporting level 2 documentation.
[list]
Org Chart ( no names just titles and hierarchy)
Controlled distribution list and sign off
Change and revision history
My position, rightly or wrongly, is that the QA Manual is all about painting a conceptual picture of my business as it relates to the standard and responsibilities. I strive to keep that fairly static. I reserve my energy and press for detail and strong change management around my procedures and WIs etc.

I understand, of course, that the manual may need to have more content depending on your industry and the standard involved. I just always strive to keep documents of any kind, brief, pertinent, current and accessible to the people who need the information in that document. I am big on visuals, diagrams and flowcharts and stingy with narrative.
As far as four pages go, honey that isn't a quality manual that is a haiku!
Good luck and moderation in all things!
Regards,
Mary


Very nicely stated, Quality Gal. It distresses me that this whole thread has been on the meaningless question of "how many pages" as if that mattered. Is there a paper shortage I haven't heard about?

It's the content that matters, folks! And, Quality Gal hit the content discussion squarely in the head!:applause:

PS: Is that 2 Guinness' I owe you now?

Very nicely stated, Quality Gal. It distresses me that this whole thread has been on the meaningless question of "how many pages" as if that mattered. Is there a paper shortage I haven't heard about?

It's the content that matters, folks! And, Quality Gal hit the content discussion squarely in the head!:applause:

PS: Is that 2 Guinness' I owe you now?

Hey who is counting!

The key issue is put very well by...


My position, rightly or wrongly, is that the QA Manual is all about painting a conceptual picture of my business as it relates to the standard and responsibilities. I strive to keep that fairly static. I reserve my energy and press for detail and strong change management around my procedures and

I see the Quality Manual as a kind of corporate CV - it sets out what you are trying to be and do at a very high level - and should be fairly static - a touch stone if you like.

The detail is more appropriately placed and more easily controlled in Level 1 and 2.

Arthur

My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn


Hi Dawn,

It depends of course on your exact company structure but a colleague in a firm I used to work for managed to write a fully certifiable TS 16949 handbook that ran to six pages. It was not only certifiable but was passed at his next re-audit, so such things are possible. His trick was to really look at his core processes and design a very neat and concise flow chart, which he then only really added comments to. Of course, work instructions, control plans etc were not included in that, so the entire QMS Documentation was more than six pages, but the handbook itself was short.

When I worked for a major german electrical company, their QMS (ISO 9001:1994) documentation was split into levels and neither the divisional nor the plant handbooks were more than 20 pages for a very complex organisation.

Personally Im a big fan of conciseness, at the least the company Ive just joind has only three files of Documentation, a big step up from the seven at my last company ;-(

andy M

He was an old style 1994 auditor - spent more time pouring through procedures than asking questions. Unfortunately I had calmed many of this organizations fears of ISO, and an auditor with this attitude made them comment "this is what we were afraid of." As it turns out one of the unique ways we addressed the standard in their quality manual was by putting a matrix in the appendix of their manual listing the ISO requirements and the internal documents that addressed it. For Infrastructure and Work Environment we referenced the Management Meeting minutes. That's when he said "you can't throw minutes in front of me to prove you meet a requirement. That's not acceptable."

What can an org do when they know they are right, but the more they question the auditor he was displaying extreme aggrivation and raising his voice to the point of the org worrying if they are going to get recommended for registration or not.
I encounter this all the time.
I won't get on my "auditors ain't what they used to be soapbox" but I will say I have lodged formal challenges with both registrars and their certification body and have never had a situation where I lost competely. Most of the time I was supported and worst case I had to meet the auditor in the middle but he had to modify his position as well.
Again I lobby for seperate manual and documentation reviews from the initial on site visit. I want to correct the documentation or fight for my position independant of the stress and constraint of the on-site audit.
I also will not let them continue the audit and unload on findings only at the wash-up meeting. That is some crap. You have the right to explain yourself or ( in the case of a major finding) offer immediate actions that can reduce it to a minor.
I make it clear at the beginning of the audit and the one auditor that blew me off and did it anyway I put in writing to the registrar I never wanted him back in my facility and why. We had a different auditor the next year.
YOU ARE PAYING THEM! YOU ARE THE CUSTOMER! You are paying for a knowledgable, thorough auditor that will provide you with an honest assessment of your QSM based on the boundries and content of the relevant standards. You are not there to please them or for your company to deliver their vision of compliance.
A good auditor tries to see your reasoning and logic in content of your approach to compliance. If it fits and is prudent their opinion is just that!
I also make cure I get a resume for every auditor coming under my roof and have even conducted phone interviews before they showed up.
I have rejected some auditors and said they didn't measure up on paper.
I am a reasonable person but have little patience for people who do not know how to do their job!
Ooh did this hit a nerve for me???? Yes I think so!
Regards,
Mary

I encounter this all the time.
I won't get on my "auditors ain't what they used to be soapbox" but I will say I have lodged formal challenges with both registrars and their certification body and have never had a situation where I lost competely. Most of the time I was supported and worst case I had to meet the auditor in the middle but he had to modify his position as well.
Again I lobby for seperate manual and documentation reviews from the initial on site visit. I want to correct the documentation or fight for my position independant of the stress and constraint of the on-site audit.
I also will not let them continue the audit and unload on findings only at the wash-up meeting. That is some crap. You have the right to explain yourself or ( in the case of a major finding) offer immediate actions that can reduce it to a minor.
I make it clear at the beginning of the audit and the one auditor that blew me off and did it anyway I put in writing to the registrar I never wanted him back in my facility and why. We had a different auditor the next year.
YOU ARE PAYING THEM! YOU ARE THE CUSTOMER! You are paying for a knowledgable, thorough auditor that will provide you with an honest assessment of your QSM based on the boundries and content of the relevant standards. You are not there to please them or for your company to deliver their vision of compliance.
A good auditor tries to see your reasoning and logic in content of your approach to compliance. If it fits and is prudent their opinion is just that!
I also make cure I get a resume for every auditor coming under my roof and have even conducted phone interviews before they showed up.
I have rejected some auditors and said they didn't measure up on paper.
I am a reasonable person but have little patience for people who do not know how to do their job!
Ooh did this hit a nerve for me???? Yes I think so!
Regards,
Mary


Amen...now... get your blood pressure back down...

You are again, absolutely correct.

What can an org do when they know they are right, but the more they question the auditor he was displaying extreme aggrivation and raising his voice to the point of the org worrying if they are going to get recommended for registration or not.

Horrible situation, isn't it? I've had this happen on a few occasions.

What I do is:
1. Attempt to deal with the situation if possible - eg, by attempting to discuss their interpretation/understand what they're saying, so I can demonstrate more evidence. That means I must know the Standard(s) in question at least as well as they do
2. Be prepared to provide evidence in support of up anything I disagree with them about.
3. If they start to behave badly (eg, I think extreme aggravation and a raised voice = unacceptable behaviour), I would either:
a/ terminate the audit, ask them to leave, or
b/ agree to disagree.
Either way, my next step would be: immediately contact the organisation & their Technical Manager & notify them of the problem.

You'd need to make sure *your* blood pressure is reasonable, and stick strictly to objective facts in putting your case.

4. Give the organisation the benefit of the doubt - allow them to try to fix the situation. If they aren't able/willing... then switch to a certifier that can. (This time, taking a lot of care in selection!)

I strongly support Quality Gal's view:


YOU ARE PAYING THEM! YOU ARE THE CUSTOMER!

You are paying for a knowledgable, thorough auditor that will provide you with an honest assessment of your QSM based on the boundries and content of the relevant standards. You are not there to please them or for your company to deliver their vision of compliance.


Absolutely. It's yourcompany - not theirs! And the certifier must provide a knowledgeable, thorough and competent auditor. ISO 19011 has plenty of information about what an auditor should be, attributes, conduct of audit, etc.

A good auditor tries to see your reasoning and logic in content of your approach to compliance. If it fits and is prudent their opinion is just that!
Couldn't agree more.

I also make sure I get a resume for every auditor coming under my roof and have even conducted phone interviews before they showed up.
I have rejected some auditors and said they didn't measure up on paper.
I am a reasonable person but have little patience for people who do not know how to do their job!


Well said.:applause:

What was that about not getting on your soap box? I agree totally.

You know, there is an ad-hoc group of people working under the auspices of the TC-176 developing material to assist adequate auditing techniques. The material is available at http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/138403/3541460/customview.html?func=ll&objId=3541460&objAction=browse&sort=name.

One of the documents developed is titled: "How to add value during the audit process" and it is available at http://isotc.iso.org/livelink/livelink/3553372/APG-HowtoAddValue.doc?func=doc.Fetch&nodeid=3553372 .

One of the litmus tests in order to check if a finding is adding value to the organization, is the question:
"...Will the solution proposed by the organization in response to negative findings be useful? . . ."
I am curious if you were to ask this auditor how much better the organization in question would be, after they revise the manual to include what he wants, what his response would be....







This is very true. One of my gripes with audits (and auditors) is they both become the be all and end all of any system and are given undue priority in that system - whereas any other system prioritizes the design bit (the getting it right first time).

Plan above Check if you like.

.... and this from an auditor! :bonk:

When I joined my present company early last year, we had 26 controlled copies of the Quality Manual and Quality Procedures scattered around the plant (1 in each section) I had 4 in my shelves (Quality copy, Master copy, Auditors copy and 1 spare). This is great as everyone can look at it, but when I came to change ! section, I had to recall, edit, rebind and reissue all 26 copies. NOW I have 3 copies, 1 for the shopfloor, 1 for me and 1 for the MD

I usually put a single page manual in, have been through a few certification audits with the format, no problems so far.

you will all want a copy but i'm not posting one (yet), i will say just read the standard and create what it asks for. Forget the QS9000 days and think out of the box a little.

It can actually cover half a page of A4 but it is still "1 page"


David