Quality Manual Organization and Structure including Numbering

[DonkeyKong]

Manual form

Another manual I am working on took a 5 step form rather than the so called eight...since their is really only 5 meaty sections of the manaul...Product Real, Resource Mgmt., Mgmt Responsibility, Meaurement, Quality systems.... I may be wrong...but I keep very similiar to the standard sans the 1st three sections being consolidated into the Introduction part of the Manual.

As always...enjoy the sight and its information.

Chris. S

 

[B Hartley]

Marc,

In my recent last full time employed position (now working on Client contracts under my own Company) as a Quality Manager within a large Global ICT Company we had a Country-Wide 'Company-Wide' ISO 9001 (1994) Registration (All services all support functions --Admin, Finance, HR etc within the single Country).

The Business Management System was Intranet Web-based.

There was NO Quality manual as such!
The Intranet- published- BMS comprised of a Navigation menu system to Policies/Processes/Procedures/proformas/ref info/supplier lists/performance stats.

When asked by Customers for a copy of Quality Manual we explained we did not have one/asked what they wanted to gain from it and either invited them to view the BMS or supplied the odd policy they were interested in hard copy.


-- I suppose you could say the whole intranet web site was the Quality Manual, containing all the policies processes and procedures as opposed to a Quality Manual containing Policies and referencing to the Processes and Procedures.

Long ago the day when one had a BSI 'Stamped as approved' hard copy Quality Manual.

Best Regards

Brian H

Wonder if other forum Members adopt same 'NO Quality Manual approach (makes life easier) with their Web-based BMS's----- do I see another poll emerging on this one?

 

[Laura M]

As a matter of fact, I have seen the same thing. The policy statement, followed by a flow chart (Level 2) followed by links to referenced instructions. Worked well for the particular company because they were fairly hi-tech, building complex machines, - so everyone was computer literate.

I have a client that went to a server system, and as I re-do for Y2k, I'm thinking of integrating the documents more.

 

[Marc]

My last 2000 implementation client did something like that. They started out with a 'skeleton'. I forget what all they had, but all functional areas and it was like a tree. Everything was an active link. Even at the system flow chart level - the listing of associated forms and related procedures, etc. were right on the flow chart and they, as well, were active links to the forms. Some forms were pdf files and some were links to a database interface (front end). They technically did have a 'quality systems manual', and it was online as well in pdf with references as active links. They did a real nice job.

That's the future for most companies. I'm working on an 'upgrade' - a client I helped back in '97 in their implementation. They had 14 employees then and 1 computer. They now only have 13 employees but have 14 computers. They're moving everything 'online'. So - even small companies are doing this.

When I worked with Motorola everything was intranet-internet -- available world-wide. But they did have a 'quality systems manual' as well. Online, but they had one. Well, there were many, actually - facility level, sector level, etc.

So.... Thinking back, I believe every one of them did have an actual manual.

 

[km2red]

I agree with Marc. Most QM's I have seen are cookie cutters of the standard themself. 9000:2000 attempts to make things a little more indepth. Currently, I'm locked in a struggle with our 3rd party auditor. He believes that the QM should be an integral part of your 2000 system, that outlines your processes, etc. I agree it does it to a point, but level 2's get you into the "nitty-gritty" of how things are done, who's responsible, etc.

 

[Marc]

What the 'new' standard does is confuses issues which were formerly well categorized and made this confusing document wherein there are more back and forth references than you can shake a stick at. And don't start me on the topic of 'subjective'.

The more I get into this the more I dislike it. It almost reminds me of moving from written tests to oral exams in college. There's a whole lot more explaining to do than before and a whole lot more 'interpretation'.

This great emphasis on a quality manual is down right silly. Who are these consultants and auditors who want to tell you where and how to define your systems?

I also dislike the Customer Satisfaction and Continuous Improvement BS. You can't mandate these things in part because they're naturally occurring anyway. How else do companies stay in business? Not to mention Customer Satisfaction, like Continuous Improvement, is relative.

 

[David Mullins]

Yeah Baby!

Marc,

In the words of Sharon Stone:

YES. YES. YES.


Or Billy Crystal:

"Don't get me started on that!"

 

[Alf Gulford]

This is part of the reason the FDA and many 'regulated' medical device organizations are walking away from ISO 9001:2000 and getting ready to get registered to ISO 13485:200x. Not only are Customer Satisfaction and Continual Improvement ridiculously subjective, they're no-one elses' business. As Marc suggests, if a company fails in either area they're toast anyway.

Another reason for going down the ISO 13485 path is that ISO 9001 is expected to continue veering off in this unfortunate direction whereas ISO 13485 is expected to stay on course.

Alf

 

[Marc]

ISO 13485

Please, Alf - start a new thread on ISO 13485 (we've gotten a bit off topic here me thinks) and tell us a bit about it. I know nothing about it. Maybe I should buy it and find out what I'm missing out on here.

 

[Alf Gulford]

Sorry, Marc.

I wasn't trying to de-rail this discussion - just adding something that I thought was connected.

My apologies. I'll see if I can figure out how threads are started and do that in the FDA slot (actually, I think I recall one there somewhere already).

Alf