QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do?

[Pennington]

Sixe of Quality Manual

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

 

[Sam]

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

 

[Bill Pflanz]

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?

Bill

 

[Puzzle]

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]

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?

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

 

[Peter Fraser]

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.

 

[Bill Pflanz]

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

 

[Rob Nix]

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.

 

[The Taz!]

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.

 

[Teri - 2011]

TOTAL of 12 pages, INCLUDING appendix

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.