Quality Manual Organization and Structure including Numbering

[juliedrys]

Re: Quality Manual- Regurg of the standard ?

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

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

--Then, spend the extra time on developing visual, user friendly, colorful, flow chart type Process Instructions that will make a positive impact almost every time.

I agree with this post. I recognize that the standard does not require that the manual include anything more than the scope, the reference to procedures and the description of the interaction of processes. However I find it useful to include the policies in this document, and what that means is addressing the requirements of the standard; the path of least resistence here is to keep the structure and most of the words of the standard.

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

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

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

Julie

 

[David Mullins]

Re: Re: Quality Manual- Regurg of the standard ?

Originally posted by juliedrys
I prefer to spend my time making useful and usable flowcharts/process maps.

Sounds costly on a consulting basis!

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

 

[juliedrys]

Re: Re: Re: Quality Manual- Regurg of the standard ?

Originally posted by David Mullins
Sounds costly on a consulting basis!

Indeed, it can be. It's more common for me to help them design the look and feel of the documentation and teach them how to do it. This is better for them in the long run anyway.

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

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

Julie

 

[SteelMaiden]

Re: Re: Re: Quality Manual- Regurg of the standard ?

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

Careful David, you may need the services of a paramedic some day. The ones I know, I would trust more than a lot of doctors.

 

[David Mullins]

Re: Re: Re: Re: Quality Manual- Regurg of the standard ?

Originally posted by SteelMaiden
Careful David, you may need the services of a paramedic some day. The ones I know, I would trust more than a lot of doctors.

I was the quality manager of the first acute health ambulance service in Australia to be certified to an ISO 9000 standard, so I am confident I know (knew) the game from an Aussie viewpoint.

The definition of paramedic, causes paramedics concern!

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

 

[JodiB]

Originally posted by Jim Wade
Put the stuff required by clause 4.2.2 anywhere you like in your system and tell the registrar (in the interpretation document) that you don't have a Q manual but they can find scope, justification, procedures and process descriptions here, here and here. If they want to call those places collectively a Q Manual, fine.
[/B]

I don't think you can get away with saying that you don't have a QM since 4.2.2 says that you shall have one and that within it you will have specific things. If you want to make the argument that these items live in disjointed pieces of documentation within the organization and therefore your QM lives here and there and there, well that just sounds ridiculous to my mind. Why make things harder than they have to be? If you have these items of documentation then why not bundle them into one place? I haven't looked up the specific definition of "manual" but I would hazard a guess that it means a compilation in one place.....

 

[Aaron Lupo]

Originally posted by Jim Wade

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

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

rgds Jim

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

"The quality management system documentation shall include:"

b.) "A QUALITY MANUAL"

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

 

[Randy Stewart]

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

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

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

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

 

[Aaron Lupo]

Originally posted by Randy Stewart


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

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

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

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

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

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

These are JMHO so take it as you see fit.

 

[James Gutherson]

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

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

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

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

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

'

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


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

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

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

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