I decided to start this thread after a discussion in the following thread:

http://Elsmar.com/Forums/showthread.php?s=&threadid=4208&perpage=15&pagenumber=1

The discussion was related to viewing examples of quality manuals and other documentation that have succesfully passed an ISO 9001:2000 audit. I figured that this was worthy of it's own thread.

I have received a lot of great advice and information from here and have reached a point where I feel I can start contributing and hopefully helping others. So to start this off, here is a copy of my Quality Manual that has passed an ISO 9001:2000 audit.

For those of you who wish to post anonymously you may either send me aprivate message or an email and I will post something for you. There are some other people who are willing to do the same as well.

Thanks Richard....I'm starting to teach more 9K1 stuff and showing folks examples of materials saves a whole lot of words.

BTW...I'll be back your way next month most likely.

Wow. If I had known that it would be used as a teaching aide I would have charged for it :vfunny:

I hope that's it's helpfull for your classes. Let me know when you might be around.

Hello all. My first post after lurking here for a few months and reading all the fascinating discussions.

If anyone’s interested, attached is the Quality Manual I compiled for my company, and which has passed muster for ISO9001:2000. We’ve had BS5750/ISO9002 since back in ’94, were recommended for certification to 9001 last November, and received the certificate a couple of weeks ago.

No non-conformities, I’m glad to say. Actually our external auditor (from BSI) said she wished she had more clients in our area so that she could bring them along and show them how it should be done! (My bosses liked that bit especially, and patted me nicely on the head. Pity the goodwill never lasts!)

I must say, we found the transition really quite quick and easy, but maybe that was because we’ve been travelling the TQ/Business Excellence road for quite a few years now.

The Manual is a bit different to most that I’ve seen. We used to have a top level Manual, full of ISO clauses and vacuous verbiage, but I threw it out. Total waste of time. Now, we have process maps and procedures all in one, and all kept as simple as possible. It might not be as detailed as many would like, but it suits us, and that’s all I’m interested in. Although we occasionally use the odd process map or procedure flowchart to illustrate a talk, the Manual is basically only ever needed by me or the external auditor. As I always tell people during employee inductions, it’s there as a reference back-up. If they’re being trained correctly, they’ll probably never have a need to see it.

mweb

Please attach your manual if possible, it sounds pretty good !

Hello again.

I note in the FAQ that there's a limit to the size of attachment allowed. Anyone know what the limit is? My QM document is 5.24mb.

I'll give it another try though.....



edited to add: Nope, no joy. I'll have to see if I can split it. Ho hum.

mweb

The suspense is killing me :ko:

Thanks Jim

An e is on its way.

I'm sure it'll be a severe anti-climax!

Will. :)

Okay, thanks to Jim you should be able to access my QM from this URL:

*EDITED OUT. THAT LINK IS TO JIM WADE'S SITE. JIM LONG AGO WAS BARRED FROM THIS FORUM AND I DO NOT WANT LINKS HERE TO HIS SITE.

JIM KNOWS WHY HE WAS BANNED BUT REFUSED TO COME BACK AND APOLOGISE TO US.

A warning though: it's 5.2mb, so it might take a while to download.

Will.

Gee whizz mweb.

You cut the crap from the quality manual and its still 5.2 meg :vfunny:

I will have to wait till I am back in work to download this and I can suck it through a broadband !

Will,

Thanks for posting your manual! I won't pretend I read through all of it but one thing caught my eye, other than your great detail: Since your org chart has individual's names on it and it is part of your QM, what do you do when someone leaves or changes position? Don't you have to revise the entire manual then, complete with sending new copies to the registrar, etc?

Mike S.

Ah well, we only update the organisation chart every 6 months (or when there's some major shift in responsibilities, but that hardly ever happens. We're a pretty stable company:vfunny: )

Then all I have to do is update the title page of the manual, record it in the revisions log, and that's that. Pardon my ignorance, but why would I want to send a copy of it to the registrar? They've never wanted a copy before!

Am I missing something? If I am you'll have to let me know, 'cos unlike most/all the people on here, I'm not a 'quality professional.' I have not a qualification to my name. Heck, I'm not even management (used to be, but that's another story!)

:(

Will.

Will,

Pardon? Heck, you need no pardon from me! And lotsa letters after your name doesn't mean alot to me -- I prefer to judge people by their demonstrated capabilities and character, not their degrees or awards.

I was under the impression most registrars always wanted to have the latest copy of your QM in real-time. Your registrar obviously does not, so it was my mistake. :bigwave:

If it works for you, mweb, then no problem. Industry average (for manufacturing in the US) is about 7% a year, across the board. Management is a little higher due to the downsizing that happened last year.

Our regiatrar doesn't require us to send a copy either. All they want is what is applicable at the time of the audit.

The only thing I would question is the amount of detail. But once again if it works for you great. I'm trying to get ours ISO, QS, Environmental, Lean, 5S, etc. into one manual and keep that to about 20 pages. As for here, the detail is needed on the floor, not in a manual no one would read - unless you are the registrar.

As for the qualifications, I would rather have someone with floor experience than with book smarts.

Hi Richard

Your QM was most helpful.

Not wanting to be too cheeky but is there any chance of having a look at your procedures referred to in the QM.

Your help would be appreciated.

Ray.

Hi Ray and welcome to the cove :bigwave:

What procedures are you interested in? Let me know and I'll e-mail them to you.

Good Morning Richard

The six procedures are:

Control of Documents - Clause 4.2.3
Control of Records - Clause 4.2.4
Internal Auditing - Clause 8.2.2
Control of Non Conforming Product - Clause 8.3
Corrective Actions - Clause 8.5.2
Preventive Action - Clause 8.5.3

Your help would be appreciated.

Regards

Ray

Good Morning Richard: I would appreciate seeing what your procedures look like. I am writing my manual and procedures to AS9100 (Aerospace), which is somewhat more complex. If anyone has a AS9100 Part 1 manual that has been accepted by a registrar, it would help to see what others are doing.

.

Richard,

'Twas quite nice of you to take the time to post those procedures.

Hope you don't mind a few questions!

In 6.6.1 you say you review all documents at least once a year. Why do you do this? Do you find the results are worth the effort and if so, how? Do you keep any "record" of this annual review and if so, how?

In 6.2.5 you say all obsolete copies of a document (except 1 copy) must be destroyed. Since you allow employees to print uncontrolled copies, is it possible to get rid of all of these uncontrolled copies, or is the destruction requirement only aimed at known (controlled) copies?

Understand I'm not being critical, just trying to understand and learn.:bigwave:

Mike,
Spoken like a true auditor.

Richard,
I don't want this to sound like we're ganging up on you, but this is a good lesson for all.

Annual Review
If this is actually happening and it is value added no problem. I got caught with this in my procedure also. No I didn't do it and it was of no use. Get rid of it, yes it sounds good but more times than not, it doesn't happen.

Obsolete copies
Once again, sounds like the procedure I had and I got hit for the same thing (I believe this boarders on micromanagement). IF you have electronic copies make them the Controlled Copies and have them posted in a central location.
Just a suggestion, that's all. My company has made CAD Master, so our documentation has taken on the same philosophy. That way we have the same control on both prints and procedures.

Here's an excert from our Internal Doc Control Procedure that gives the general rules. This is just 1 step.

4.1 QSA Authority for Document Control and Issue
The Quality System Administrator will be designated as the central authority for the control and issue of all designated documents. This will include measuring the effectiveness of the control system, maintaining a master list of internal documents and the approval of new or revised documents.
Operations Engineering is designated as the central authority for the generation, approval, control and issue of all Control Plans.

For the purpose of this procedure the following definitions and rules apply:

CONTROLLED COPY --The controlled copies for all company procedures are located on the company computer network. All printed versions of the Procedures, Flow Charts or Work Instructions are UNCONTROLLED.

The use of uncontrolled documents (i.e. flow charts posted in work area) requires the user to verify accuracy prior to use.

To verify the latest revision level of electronic documents, see the Revision History section on the document and the master list or contact the Quality Systems Manager.

All procedures and prints shall be kept electronically and considered CONTROLLED. Any hard copy originals designated as controlled documents are to be identified by one of the following methods: colored logo, colored or textured paper, marked controlled, or stamped Controlled. All other copies shall be considered UNCONTROLLED.

Mike and Randy,

Thanks for the feedback. Both of the areas mentioned are things that I have looked at as well (they are both carry over from the prior system). The annual review is something that I think will be helpful here because we tend to change a fair amount, but most people don't think to update the procedures. Most of the people here know what they're doing and don't have to refer to the procedures and so they tend to be forgotten about (not all, but some). So this gives us a chance to compare the procedure to the actual process and current practice. The main reason it's in there is because of 4.2.3 b) where it says to review and update as necessary. The section should be reworded though, because it really applies to internal procedures and not customer documentation.

I have a pretty informal way of handling the reviews. I keep a list of all the procedures and have a section for each one that indicates when it was last reviewed, by who, if a DCN was generated, and when it is next due. This is working so far and some of the procedures have been update as a result of this. So for know, it is worth it to do. Down the road it might be a different story though.

As to the obsolete documents, for the most part this is meant for customer documentation. Our procedures are primarily used in electronic form. There are notebooks on the production floor with printed copies that are controlled (because of lack of enough computers on the floor) and all other copies that are printed by personnel are uncontrolled. When we do change a procedure we replace all the controlled copies and file one copy for reference. As for the uncontrolled copies, people have been trained that if they are using a procedure to make sure it is current. Looking at the text it should be reworded to reflect that the controlled copies are destroyed.

I'll be the first to admit that the way things are done isn't perfect, but the company is going through a lot of growth and change right now, so hopefully I can change some of this around to make it better :bonk:

Okay, here it is in one shot. The attached zip files contains the following:

- Quality Manual
- Document and Record Control Procedure
- Internal Audit Procedure
- Non Conforming Material Procedure
- Preventive and Corrective Action Procedure

Enjoy :)

Richard stated, Most of the people here know what they're doing and don't have to refer to the procedures and so they tend to be forgotten about (not all, but some).

Richard, Just an observation: With the new standard and the process management approach, are procedures that are not being refered to necessary?

Having many procedures that fell into this category, we took the opportunity to re-evaluate the need for these procedures. In many cases we made the determination that training (most of which is documented OJT), and the availability of flowcharts or bullet lists, depicting key points of the process were all that we required. This eliminated a lot of documentation that for the most part was nothing but "audit fodder" (we were constantly being cited for "uncontrolled" documentation - documents that were out-dated due to a lack of use, or cited for noncompliance with our own documented requirements - because the trivial details in the process changed).:frust:

With the new approach we have controlled the process (where it matters), and have eliminated a lot of frustration (and documentation).:D

ddhartma said:

Richard, Just an observation: With the new standard and the process management approach, are procedures that are not being refered to necessary?


Are they necessary? Yes and no. As it stands now they are basically part of our training program. There is a little bit of a debate here regarding this issue. Some of the people are still of the mindset that you need a procedure for everything (slowly getting better). The person in charge of the training program basically looks at it as he doesn't have to create any kind of training program since the procedures are available. I look at it as wanting to get rid of all of them (okay, well most of them).

It's an ongoing process right now to basically redesign our document structure. I've been able to eliminate quite a few procedures since being here, but there's still more to get rid of :p:rolleyes:

Good Morning Richard: I would appreciate seeing what your procedures look like. I am writing my manual and procedures to AS9100 (Aerospace), which is somewhat more complex. If anyone has a AS9100 Part 1 manual that has been accepted by a registrar, it would help to see what others are doing.Hello Hal and all!

I am attaching two revisions of our Quality Manual. The first one Rev. L, I was trying to streamline and reduce in size. After submitting it to our auditor for review he was very unhappy and felt we were not ready for the upcoming audit. So I made other changes to it went back to the old manual, we reviewed and released it as Rev. M. I sent it to our auditor he was happy with it and ended up with our AS9100A Registration. I am not convinced that Rev. L is not compliant, so please provide input. It is always greatly appreciated.

Paula

Quality Manuals:
http://elsmar.com/Forums/attachment.php?attachmentid=1643
http://elsmar.com/Forums/attachment.php?attachmentid=1642<!-- / message --> :bigwave:

Okay, thanks to Jim you should be able to access my QM from this URL:
*EDITED OUT. THAT LINK IS TO JIM WADE'S SITE. JIM LONG AGO WAS BARRED FROM THIS FORUM AND I DO NOT WANT LINKS HERE TO HIS SITE.

JIM KNOWS WHY HE WAS BANNED BUT REFUSED TO COME BACK AND APOLOGISE TO US.
Will,

I have just done a search on 'Document Control' and this thread popped up. I downloaded your Quality Manual and on first inspection it looks GREAT. I love the idea of the flowcharts as I have just started using them. I have enclosed one that we are reviewing for inclusion. We are relying more on training than documenting every step. Well done

Greg B

Okay, thanks to Jim you should be able to access my QM from this URL:
*EDITED OUT. THAT LINK IS TO JIM WADE'S SITE. JIM LONG AGO WAS BARRED FROM THIS FORUM AND I DO NOT WANT LINKS HERE TO HIS SITE.

JIM KNOWS WHY HE WAS BANNED BUT REFUSED TO COME BACK AND APOLOGISE TO US.I like the great graphics, but strangely, the one item which most caught my fancy was this note clause:
(NOTE: Any ‘revision’ or ‘change’ of documentation refers to a material and substantial change, not to changes in grammar, spelling, punctuation, numeration or pagination.)

I am incorporating that phrase into many of my documents from now on. It should be a fantastic time and effort savor. Why didn't I know about this before?:bonk: :frust:

Thanks for the wonderful tip!

I like the great graphics, but strangely, the one item which most caught my fancy was this note clause:
(NOTE: Any ‘revision’ or ‘change’ of documentation refers to a material and substantial change, not to changes in grammar, spelling, punctuation, numeration or pagination.)

I am incorporating that phrase into many of my documents from now on. It should be a fantastic time and effort savor. Why didn't I know about this before?:bonk: :frust:

Thanks for the wonderful tip!

I agree that the referenced phrase makes a great deal of common sense, and I like it, but I'm wondering if most registrar auditors will agree. I can see possibilities of problems by including the numeration and pagination part if other documents might reference the re-numbered/re-paginated document in question via page or section number.

I agree that the referenced phrase makes a great deal of common sense, and I like it, but I'm wondering if most registrar auditors will agree.
I have a similar phrase in my document control procedure and haven't had any problem with it so far.

I have a similar phrase in my document control procedure and haven't had any problem with it so far.

I've used this phrase for the past five years in our QM, and though we've been through seven different registrar auditors in that time, not one has even raised an eyebrow. :) As far as the 'numeration and pagination' bit goes, well I never reference ANYTHING by number or page, just the title...so that's another I've gotten away with! ;) (By the way, sorry you can't link to the QM any more. I'd forgotten that it was hosted by the banned JW.)

Will

(By the way, sorry you can't link to the QM any more. I'd forgotten that it was hosted by the banned JW.)
Will
All you have to do is contact Marc and he would, I'm sure, allow you to upload the oversize file for member's use. I think you could have left out the last sentence. Any special reason for repeating what we already know? :confused: