Quality Manual Organization and Structure including Numbering

Is Your Company's 'Quality' Manual....

  • Organized and numbered like ISO 9001.

    Votes: 42 61.8%
  • Organized, but NOT numbered like ISO 9001

    Votes: 17 25.0%
  • We 'Rolled Our Own' (Please comment how so in a Reply)

    Votes: 9 13.2%

  • Total voters
    68
D

David Mullins

any which way but loose

Put 5 quality managers in charge of 5 identical companies and you'll get 5 diverse views on what should be in the manual.

As one of the "made my own recipe" manual people, I'd ask this:

If we forgot about compliance with ISO 9001 and asked ourselves what should we have in the primary 'mother' document for our company (assuming a fully integrated system), what would we include.
Also, before being able to answer that, we need to determine what it is that we are attempting to gain from having this document.

Based on Marc's poll, and not wanting to start a bun fight, I'd say less than 10% of quality managers would be in a position to answer these questions. Aternatively (saving my rear end here), others probably can answer, but went for the safety net in terms of the appearance/structure of the manual.

So, how does your company benefit from the manual, and what did you put in it to meet these needs? (And therefore, why did you put the other stuff in it?)

For Lucinda's question, I'd say if you're expecting to update stuff that's in the manual more regularly than yearly, then just refer to it and make it a separate document (and make that manual smaller!).
 
J

JodiB

Oh but Bloke, I have to have reference to my procedures in the QM.

And, as you say, the QM should provide information on my company that we feel should be communicated to whomever has an interest in the QM (like a potential client or outside registrar) So that is why the org chart is there. As an "attachment", I thought that it did make it somewhat of a separate document that was nonetheless connected to the QM. Doesn't it?
 
D

David Mullins

Re: any which way but loose

Lucinda, yes, reference it, as I said:

Originally posted by David Mullins
just refer to it and make it a separate document

My companies Quality Policy has to be in the manual, right? I reference it, and other policies, and other level 2 docs (system level procedures, if you like).

Org chart, suit yourself. Mine states position titles, not names, so I've left it in the manual because it is important, and something which was previously unknown across the organisation (can you believe). The names get aligned to the position in a system procedure called "level of authority schedule", which is a matrix of positions/people and responsibility categories, with the intersecting box describing the level of authority.

Forget the registrar. You've got a manual to provide the starting point/launching pad/GO space on the monopoly board for your staff to follow and understand the system. Second purpose is as a marketing tool - provided in tenders etc. So don't make it long and complex.
 

Marc

Fully vaccinated are you?
Leader
> But now I have a question: Someone mentioned to me
> somewhere that I should consider having an appendix of
> approved procedures ( or attachment, or something) with
> the manual, as opposed to referring to the procedures
> within the sections. This was to allow me to add/
> subtract, etc. the procedures without doing a revision of
> the manual.

That's the 'Master List'. They're nice in some cases. See Doc_Matrix.pdf in the pdf_files directory as an example. But I put references in every section - the relevant document(s) - within the quality manual.

> The Organization Chart is something else that is supposed
> to be an attachment for the same reason.

Keep org chart separate. Doesn't even have to be a part of the manual physically. Org charts are often frequently updated.

> My question is : are these pages rev'd individually then?
> Do I put some sort of rev level on them?

Rev and control like any other document. There are so many systems it's - well, up to you. With smaller clients, I encourage them to use date with a revision history on disk (past versions - not a listing of exact changes).

> And in the page numbering of the manual (both on the page
> and as referenced in the Table of contents), are these
> attachment (or is it "appendix" ? ) pages listed
> consecutively or do they have a different numbering
> scheme? The org chart is inserted around page 8.

When an auditor asks about the org chart we go to who ever controls it and show the auditor. Its not an appendix, or an attachment or anything but a stand-alone document.

You're over complicating things IMHO.
 

E Wall

Just Me!
Trusted Information Resource
References

I have to concur with Marc. You NEED references (not attachments) in the manual to lead someone to the exact procedure that supports the process described without having to get anyone else involved! Unless you have very few documents or lengthy titles, I would surprised if (with very limited knowledge...not someone trained or already familiar with the system) someone new could take the ball and run with it...which is (IMHO) always the best learning method.
 
J

JodiB

Guess I'm not being real clear

Yes, I know I have to reference the procedures. I structured the manual to address each part of the standard in order. Within each clause part, I have two sections: Policy,and Responsibilities. I used to also have a third: Procedures. So for 4.2 for instance, there is the general verbage related to our policy and practice for documentation, and then a part that describes functional responsibilities. With a third part there, procedures, I would list the applicable procedures such as control of docs, control of records..

But advice of one of my instructors was to not list the procedures after each section because we may add or remove(?) or change the name of, or whatever, the procedures and this would require a revision of the manual. He said that if I had an "appendix" of quality procedures that listed all the procedures in one place, then the "appendix" could be updated without changing the manual itself - or at least requiring a revision.

So the question is how do I number this appendix, and is it still considered a reference to procedures within the manual if it is an appendix - or would a statement under 4.2 referring to an appendix of procedures be "reference" enough.:confused:

So yes, I'm a big dummy. Completely clueless.

And I have little tables of information within the manual too,(like showing the structure of our documentation) and they are "Figure 1" or "Table 1", and I don't know if these pages are number consecutively with the manual or if they are un-numbered, or if they have their own little numbering scheme like ii and iii.:bonk:

This is what I was trying to ask. Is this any clearer?
 
D

David Mullins

Going to the Doctor about your appendix?

Lu,
Lots of ways to do it.
Yes you're better off with the procedures referenced in one spot in the manual.
If you put it in an appendix with the intent of updating the appendix without revising the manual version, you'll simply need to control the appendix in addition to the manual. That is, list the appendix in you document register (or whatever you call it) as a separately controlled document, albeit an attachment to the manual.

Personally (And I'm one of the people who made up a structure to suit the company not the standard) I think you're overdoing the content of the manual. Document structure diagrams are great for awareness training, or even pasting in the doc control procedure, but not the manual. Likewise the responsibilities stuff. People won't (imo) go to the manual for responsibilities, they go to procedures or job descriptions. I'd use the structure and content of your responsibilities information as the basis for briefing management, etc, on their responsibilities - this is a course I actually run with managers and supervisors during the implementation phase.

In short, the advice you received was correct about not including things in the manual which will change on a regular basis (let's say more frequently than annually), as you'll be reproducing the manual for every revision. Keep the manual simple - That's been said soooo many times here, I don't know why people insist on re-writing 9001 as their manual.

PS - In the electronic version of my manual (accessed from a shortcut on everyones PC desktop which takes you to a basic index of the whole business sytem - without buying any software), the list of procedures (which is bookmarked (for direct hyperlinking) within the manual) is used as the master list (date of issue control stuff) and are hyperlinked to the procedures (files stored on server) for instant access. Likewise in the forms manual, job description manual, etc. The manual also contains an easy find index that matches words or phrases to procedures. So If you want to know the process for applying for leave you can look under leave, sick, annual, maternity, paternity, long-service, holidays, etc, etc. and they take you to the correct procedure or form. (I getting off the subject, but I'm trying to display the versatility of not being bound to a 40+ page manual that reverbages ISO 9001)

Hope I'm helping?????
 

Marc

Fully vaccinated are you?
Leader
Does this help or am I still confused?

Originally posted by Lucinda

But advice of one of my instructors was to not list the procedures after each section because we may add or remove(?) or change the name of, or whatever, the procedures and this would require a revision of the manual. He said that if I had an "appendix" of quality procedures that listed all the procedures in one place, then the "appendix" could be updated without changing the manual itself - or at least requiring a revision.

So the question is how do I number this appendix, and is it still considered a reference to procedures within the manual if it is an appendix - or would a statement under 4.2 referring to an appendix of procedures be "reference" enough?
Ummm, yes and no. :ca: As always, depends upon the complexity of the company. But in most companies the answer is Yes. The references in the 'quality' manual are to top level systems and while the referenced documents may change internally, as long as the identification doesn't change there isn't an issue. So - typically referenced documents in a quality manual are almost always relatively stable. You're not going to have an organization chart one week and obsolete it the next week. Your level II nonconformance system document - the top level (level II) - will be there even if changes to it are made internally. Why would you want to rename a high level document like that?

The key is how far down you go in your references. You surely wouldn't reference a process instruction, as an example. If you did - yes - your 'quality' manual would be constantly under revision.

A simple way to tie everything together is in a document matrix. I guess you could make it an appendix. I don't see why you'd need to or want to. One I've had posted here for years as an example (a study in simplicity) is in the pdf files directory and as I remember it's titled Doc_Matrix.pdf. It ties everything together pretty well. It has really come in handy for my clients going through 'the upgrade'. Of course, we had, as in the example matrix I cited above, procedurs identified by disk file name or document title. So - even the ones with paper manuals - they already had 20 divisions of documents. We kept the 20 divisions as 'sections'. Because the ID of any given document was unrelated to the ISO 1994 numbering system, there was no need to change the base of their systems. I steered clients away from linking to the ISO 9K numbering scheme years ago. So all my client does is takes the blank manual (well, I'm doing the initial tailoring) and inserts the references from the old manual as they correspond in the new numbering / classification scheme. Two 'new' flow charts and - voilia - they're done. Time for the upgrade audit. This year I have gone through two and I have 2 on deck.

By the way - I just uploaded the base manual I've used with 4 clients now (remember - it's just the base. It has to be tailored) to the Members Access directory (it's been available to the premium folks - along with a lot of other stuff - for a while now). :thedeal:
 

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Marc

Fully vaccinated are you?
Leader
Re: Going to the Doctor about your appendix?

Originally posted by David Mullins

PS - In the electronic version of my manual (accessed from a shortcut on everyones PC desktop which takes you to a basic index of the whole business sytem - without buying any software), the list of procedures (which is bookmarked (for direct hyperlinking) within the manual) is used as the master list (date of issue control stuff) and are hyperlinked to the procedures (files stored on server) for instant access. Likewise in the forms manual, job description manual, etc. The manual also contains an easy find index that matches words or phrases to procedures. So If you want to know the process for applying for leave you can look under leave, sick, annual, maternity, paternity, long-service, holidays, etc, etc. and they take you to the correct procedure or form. (I getting off the subject, but I'm trying to display the versatility of not being bound to a 40+ page manual that reverbages ISO 9001)
Excellent way to bring everything together.

> Likewise the responsibilities stuff. People won't (imo) go
> to the manual for responsibilities, they go to procedures
> or job descriptions. I'd use the structure and content of
> your responsibilities information as the basis for
> briefing management, etc, on their responsibilities - this
> is a course I actually run with managers and supervisors
> during the implementation phase.

I do have some responsibilities defined within systems manuals for the main systems. Since the positions are high level, they rarely change in smaller companies so the issue becomes moot. The poit being, I agree that responsibilities are spread out throughout many documents / procedures/ etc.
 
D

David Mullins

SIZE DOES MATTER

After a little discussion with Marc, I think the size of the company plays a major role in determining the practicalities of the structure of the QMS.
Marc's base manual reminds me of the pre-1994 days when we used quality plans instead of manuals and layed out the responsibilities in the plan document.
I concede that smaller companies who go for certification are better off making compliance as transparent as possible, and thus benefit from following the Standard approach to structure.

However, I believe, to get the most out of your management system, you've got to be develop one that has a structure that is specific to the organisation, it's products, needs, customer types, etc. Benefits tend to be specifically targeted in this style of structural approach, rather than the across the board gains realised by companies implementing a proper management system for the first time.

So (in summary) I guess the size of the company and maturity of the management system both play a significant part in determing QMS structure.
 
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