Quote:
Originally posted by John The Auditor
One of my favorite manual contain 60 linked flowchart - that's it.
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I don't think that the issue is that simple, but I agree with you. The problem generally lies in that companies that have been in existence for a while already have procedures in place. In addition, my ISO 900x experiences - dating back over 10 years - is that many auditors will be going through the documentation and say "Well, what about line item x? Specifically where does it say that in your supporting procedure?" To me it was, early on, enough auditor bull - give the auditor something simple enough that everything is there and directly points the auditor to the appropriate documentation. And don't miss even 1 line item. I have since prepared my clients for, and expect (sorry
) a really stupid or pricky auditor. If we 'get a good one' - all the better. If we get a 'picky' one we're prepared.
I can't remember if it was in a thread here or in the ISO ListServe *** DEAD LINK REMOVED *** but there was a good discussion on whether you even need a quality manual. There was some good back and forth. I personally 'require' clients to have a quality manual because they are so simple to do and they serve as a directory - pointers if you will - to fulfillment of the requirements.
It also may be that you know what you're doing. The 'Call for Auditors' has brought every known type of soul out of the woodwork and into auditing. Just as it has in consulting, I will add, being a consultant. Everyone seems to have taken early retirement and is now an auditor or consultant. I have run into some of the stupidest auditors that the world has ever seen. Many (most?) simply do not accept the 'outline' idea.
A quality manual is so easy to do - and for most 'starters' ties everything together that I've never seen it as an issue. I'm in the middle of my third and 4th update to the 2000 version and have a simple, fill in the blanks manual. Take old manual, bring the pointers over. Check old manual for additions (they all have modifications to some degree specific to the company) and bring them over. A morning's job if you stick to it.
Do I agree with you? Yes. But I bet that to the largest % of auditors that would be like waving a red flag in front a bull. In part I say this because I went through something similar (auditor ignorance) with flow charts in 1995. The auditors came in and it took close to an hour of negotiations before the auditors would conceed that flow charts are, in fact, procedures. It was the first company that I did all the level IIs in flow charts. The auditors had never seen such a thing! Though converted and dated in1996, if you take a look at these
old flow charts you can see some the originals. They have been posted there (here?) - free - for almost 6 years now to give people ideas about how to approach simplifying documentation.
This last June I finished up with a client who had everything on the intranet in chart fashion. It was really neat. Started with a top level 'company' flow chart - sorta like a tree and all the sub-processes were branches. Everythig was interlinked. No - no Mickeysoft bull and bugs - just a cheapie program (which is really, really nice, called SmartDraw). Systems flow charts were so linked that - click on a 'referenced Form' and it would open right up. I originally argued against it and its complexity, but they over ruled me and did it - and did one heck of a job. I still think they over did it, but it really is nice.
Again - I agree with you, but reality aften smacks us in the face when we're not prepared. I just wish I could remember where that thread on whether or not you need a quality manual is. If I run into it I'll come back to this thread and post the link.
> The whole system conains not one word of ISO speak
The only 'Iso Speak' is in the quality manual its self. Limiting it to that space can do wonders.
> Another is a 600 person project managment group whose
> total manual is about 30 pages.
If you're referring to the quality manual, the 'form' I use is about 21 pages, 10 point Ariel, includes the 'Figure 1 diagram, complete index, references, etc. I don't think that's too long.
ISO 13485
Linear Mode
