Does a Quality Manual have to be in the format of ISO 9001:2000?

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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#22
I agree with everyone's comments. The bottom line is KISS.

The QA Manual is strickly a policy statement from your company whatever format your company chooses. The Quality Procedures are how your company is to carry-out the Policy (in my opinion). That simple.

Just make sure that somewhere in the QA Manual or QA Procedures the requirements (ISO9001:2000) for a procedure is addressed.

On the flip-side: I to am curious to see the 1 page Policy Statement. I can only guess that is it something like "Our company strives to meet the requirements of the ISO (ISO9001:2000) and meet or exceed our customer's expectations (maybe a little more in depth)."


Coury Ferguson
Program/Contracts Manager
 
S

S. Thompson

#23
Coury Ferguson said:
On the flip-side: I to am curious to see the 1 page Policy Statement. I can only guess that is it something like "Our company strives to meet the requirements of the ISO (ISO9001:2000) and meet or exceed our customer's expectations (maybe a little more in depth)."


Coury Ferguson
Program/Contracts Manager
It is in more depth that this Coury. It goes on to say:
'that we are committed to the quality of service we provide to meet our customers requirements'
'we have positive internal communications at all levels....... creating an understanding of businesss processes throughout the organisation'
'Quality training is provided to all staff at induction............trained in line with their job specs...........aware of company procedures'
:)
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#24
I thought it was a little more in depth.

I have written numerous manuals in my career (from companies manufacturing fasteners to companies that included 5 different facilities), but the 1 page caught my interest.


Coury Ferguson
Program/Contracts Manager
 

Jim Wynne

Staff member
Admin
#25
Wes Bucey said:
I like this. Any other comments from Cove members?
Since you asked...

I'm reminded of a quote from Blaise Pascal, in a long letter to a friend: "I would have written a shorter letter, but I didn't have time." (also sometimes attributed to Mark Twain)

And another from Truman Capote, upon being told that Jack Kerouac had completed On the Road in a matter of a few weeks: "That's not writing, that's typing."

If brevity is indeed the soul of wit, it can't be brevity for the sole sake of brevity. To make a piece of writing concise takes effort and deliberation. I agree that quality manuals should be as short as possible, but there's a difference between editing and truncation.

IMO, the "manual" in question doesn't meet what I consider to be the two foundational purposes of a quality manual. A quality manual should,
  1. establish the requirement for the existence of a quality system that meets the requirements of [your standard here], and
  2. explicitly grant responsibility and authority to the individuals (or positions) who must design, build and maintain the system and,
  3. describe the expectations of management with regard to output.
Without at least those three things, the manual serves no useful purpose.

With regard to the process interaction diagram, don't we already know that there is interaction between processes? The diagram shows this in a rather vague and noncommittal way, but doesn't say anything about how and why and when processes interact or the significance of the interactions. Couldn't the diagram in the posted document be used in almost any quality manual?

Most quality systems that fail do so because top management hasn't delegated authority to the people who have to make the system work, and hasn't adequately explained what's expected. The quality manual should be the foundational document of the system, and it should be top management's way of firmly committing itself to the existence and maintenance of the system.
 
Last edited:

Paul Simpson

Trusted Information Resource
#26
Where is the manual?

S. Thompson said:
Hi All,

This is our 1 page QM. Works for us and our external auditor follows it perfectly well.:magic:
I found a one page index but the actual manual wasn't there!

But seriously ..... there has been a lot of discussion recently about the 1 page quality manual and I have yet to see the point. I agree with JSW05 - the manual has a certain minimum requirements it must cover - not all of them are on the page - more importantly if the "manual" only serves as a link to the real documents that describe the organization's policies, organization etc. then they should be in the manual.

As to the 3rd party auditor accepting this manual - I am a little surprised but don't see this as being the definition of a good manual.
 
F

floman

#27
Quality Manual in HTML

Hi, I'm new to the forum, and glad I found you, so Hello to you all.

I've been browsing through the forum and was intrigued by the one page manual idea - although it's really 30 if you include the appendices. I've been given the task for writing our quality manual. Our company has 12 people and we make digital cameras for scientific applications. Our current plan is to be in ISO compliance, but we're not ready for certification. We already have a comprehensive quality program in place with ECOs for document control and CARs and a plethora of other procedures in place, and a CEO who is committed to quality, which is the name of our game.

I started a manual 3 years ago based on a download I got from the web, but it was just too formulaic and plainly unreadable. I wanted something that a new employee could read without falling asleep or getting the idea that our company was hidebound by rules and regulations. We already have many of the procedures documented in plain American on our server. What I was thinking of doing was creating a one page manual as a web page, and linking the documents to the page, so that when the reader clicked on the link to, say, ECOs, the relevant document would come up, and on that document there would be a direct link to all the ECOs after the process description. So he would go from manual, to process, to actual documents.

We keep original designs and documents in Word or Solidworks or other formats and consider them dynamic, and freeze revisions as pdf files - which is what the manual would link to.

So, my questions are, "Is this a reasonable approach in light of meeting the ISO 9001:2000 standard?" and "Is anyone doing this already?" and "Are there any pitfalls with this approach?"

I thank you for your considered responses.
bp
 

Jim Wynne

Staff member
Admin
#28
Welcome to the Cove, Floman :bigwave:

Your quality manual has to meet the requirements in 4.2.2 of the standard. There is no requirement for the manual to be on paper. Many companies use electronic documentation systems. Are there any pitfalls? No more so than in any other process. Sometimes you don't find the pits until you fall into them, :lol: but the Cove is a great resource for help in avoiding those tumbles.
 

Helmut Jilling

Auditor / Consultant
#29
floman said:
...We already have many of the procedures documented in plain American on our server. What I was thinking of doing was creating a one page manual as a web page, and linking the documents to the page, so that when the reader clicked on the link to, say, ECOs, the relevant document would come up, and on that document there would be a direct link to all the ECOs after the process description. So he would go from manual, to process, to actual documents.

We ...freeze revisions as pdf files - which is what the manual would link to.

So, my questions are, "Is this a reasonable approach in light of meeting the ISO 9001:2000 standard?" and "Is anyone doing this already?" and "Are there any pitfalls with this approach?"

I thank you for your considered responses.
bp

I don't buy the idea of a one page manual, but your idea makes sense to me. Many companies use a webpage to hyperlink the documents of the system. I would lokk at the whole thing as you quality system, and not get hung up on which part is the "manual." The whole thing could actually qualify. I like the idea, and it is easy to access and control.
 
#30
HI All,

I dont think there is any problem with a 1-page QM. As long as it fulfils the requirements of the standard and works for you then no problem. See below link to the discussion thread for copy of our 2-page manual (1 sheet of paper).

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

Hiijing, I personally believe that a small manual is beneficial to an organisation, as people are more likely to refer to it if it is simple and straightforward. As long as the detail is included in the procedures I can't see what difference it makes. What problems do you see?
 
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