How do you structure your QA (QMS) Manual? A Historical Discussion

How do you structure the QA Manual for ISO 2000

[Russ]

Dudu,
You need to download a copy of ISO 10013, it will help explain quality manual developement. You can get it at http://www.ik.bme.hu - Link was: /~mohacsi/sqm/documents/10013.html

DuDu,

The easiest way I have found (I have done this 4 times) is to copy sections 1 through 8.5 of the standard, VERBATIM, then use the edit/replace function to replace all references to "the organization" with your company name. You will not be able to cut and paste from the electronic version of the standard, so someone will need to manually type the manual. After you are done this go through each section and wordsmith to fit your organization. Be careful when deleting anything. This makes it virtually impossible for a registrar to give a nonconformance for the manual not fitting the standard. Let's face it, the only reason you are writing the manual in the first place is to pass your audit and possibly send to a customer. It serves no real purpose, so make it easy on yourself. The last manual I wrote took a total of 4 hours for someone to type and about another 4 of my editing.

Good luck,

Carl-

[Marc]

-> copy sections 1 through 8.5 of the standard, VERBATIM,

For most companies this is fine. Many smaller companies bring their 'main' procedures into the manual its self (such as the 'required' 6). But the theory is correct. Don't over do your quality manual into a 2 month project.

[Russ]

Is it really that simple to make a manual like this? If that's all it takes I think I will write a new one for 9K2K. Then use a matrix to our present procedures etc.? And fill in the gaps? Am I just making it too hard?

[Marc]

I'll betcha that's been said here in at least 50 different threads from time to time.

Yes - it's that simple. ISO9K gives - what - 3 things you have to have. As far as your procedures, it says "...or reference to..."

[Jim Biz]

Are there copyright considerations needed?

Regards
Jim

[Marc]

I guess they could get nasty, but since there are probably thousands of companies which have written their manuals this way, I doubt the ISO folks would take a chance at pissing off a whole lot of companies by bringing an action against one. I'll tell you what, there would be an interesting (to say the least) debate if they (the ISO folks) actually did take a company to court over copyright violations in the company's quality manual.