Quality Manual and Procedures incorporated in same document

[Don8560]

First let me introduce myself. I was a QA Manager for 17 years and was the MR for a QS-9000 certified company. I took a little sabbatical from the quality field over the last two years, now I'm back.

The company I'm working for has seven employees and the owner wants to pursue ISO 9K2K. I've been here about 2 months and the company has been in business for 1 year. We are in the qualification stage of our product and no customer has asked us to pursue certification. I give the owner credit in being proactive in this venture.

Now to my question, I purchased a canned ISO 9K2K manual, procedures and forms that was not very expensive. It was well written and covered the standard, although we are making many modifications. The canned package had the procedures implemented into the Manual.

I see this as being a document control issue since every time a procedure is updated, we will have to revise the level 1 document. In the past one of the first questions my registrar asked during a surveillance audit, was what rev. level the Quality Manual was at. Has anyone here combined the two or do you think I should separate the procedures from the manual.

I've been lurking in this site for about a week and really enjoy the insight of other Quality Professionals.

 

[ralphsulser]

We have separate manuals for each. Our quality manual is written to address the requirements for ISO/TS16949, and references the procedures in the appropriate sections. The procedures manual has a master list of all the procedures, revision dates and a brief comment describing the last change as the first page. Then all the procedures follow, and are updated as necessary.

 

[Don8560]

Thats what I've also done in the past and it makes sense.

 

[Al Rosen]

With seven employees, why would you want more than one document? So, what if the auditor asks what revision level your manual is at? Nothing wrong with continual improvement.

 

[jmp4429]

I don't see anything wrong from a compliance point of view with including the procedures in the Quality Manual, but I think you'll find it's a pain in the butt.

Every time you need to change a procedure, you'll have to get all those signatures to change the whole manual. Of course, that means every time you create a new work instruction or form that is referenced in a procedure, you'll have to change the quality manual and get all those signatures.

It sounds to me like it's asking for either

a) A lot of extra work down the road as the business evolves
or
b) People hemming and hawing at changing something that really needs to be changed, in order to avoid all that hassle.

 

[cncmarine]

Keep it separated

Your QMS is very rarley change.So put all of your policies under one rev and have your procedures under thier own revision.


I have seen companies have a ISO 9001:2000 manual and keep the old 1994 format with their procedures.

 

[Adriane]

When I was hired at my present company 6 months ago, the QM, procedures, work instructions AND forms were all one in the same. :mg: After considerable thought and with the green light from the company President, I embarked upon the journey of separating the four. What a mess. Although it has taken nearly all of my 6 months on the job and countless hours at home, I am finding that the system works much smoother keeping 4 seperate levels of documentation.
Adriane

 

[Don8560]

I appreciate the feed back. I was going to separate the procedures out and it sounds like the consensus agrees.

 

[Wes Bucey]

I appreciate the feed back. I was going to separate the procedures out and it sounds like the consensus agrees.

In my opinion, the only reason a small, 7-person, one-year-old company NEEDS to separate out the documents is if it intends to grow and do a lot of modifying of individual procedures at frequent intervals. Then the reason is simply one of efficiency and allowing different entities within the organization to "own" one or more Procedures versus creating a funnel or bottleneck where all documents must go through one individual (when all Procedures are essentially just chapters of a single document, the Quality Manual.)

DESIRE to separate is a completely different matter (like what color car to buy - strictly personal choice.) With modern computer systems and rapid printing systems, any small organization could readily update, print and distribute ALL the Q manual including the changed procedures to every member of the organization with less than an hour of print and bind time if they need to have hard copies, ZERO time if you keep the documents in an electronic file accessible to ALL employees.

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