Minimalist approach to an ISO 9001 quality manual

S

scottknutson

#1
I have a question for all of you ISO masters regarding a minimalist approach to a quality manual. I have a client who wants a very basic manual that addresses each of the elements (they are currently registered to ISO 9002)and talks to each specific part of each element in their level two procedure (i.e. 4.9 a, b etc. would be in the procedure, not specifically mentioned in the manual. What do you all think? Is this Kosher?

When I look at the standard, it states that the supplier "shall prepare and quality manual covering the requirements of this International Standard. The quality manual shall include, or make reference to, the quality system procedures . . ."

The word that stands out here is requirements. Does covering the requirements mean talking to each and every element, sub-element and notation, or just to the elements themselves, covering the specifics in the procedures???

I can see this approach working, but wanted to hear from others. I respectfully request your inputs.
Scott
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Well, you have ISO 10013 to start with. But I saw a minimalist pass muster - simply a listing of the 20 ISO 9001:1994 sections and under each section a level 2 was referenced. All the shalls and trite verbiage required (such as "...records shall be ledgible..." [Duh]) was covered within their level 2's. The FDIS relaxes this even more as I read it.

> ...5.5.5 Quality Manual
>
> A quality manual shall be established and maintained that includes the
> following:
>
> (a) the scope of the quality management system, including details of, and
> justification for, any exclusions (see 1.2);
> (b) documented procedures or
> reference to them;
> (c) a description of the sequence and interaction of the
> processes included in the quality management system. The quality manual shall
> be controlled (see 5.5.6).
>
> NOTE The quality manual can be part of the overall documentation of the
> organization.

I personally see the function of the quality manual proper as being a policy manual at most. The less in it the better.

As long as you can point to where each item in the standard is covered, you're covered.
 
R

Rick Goodson

#3
I have to agree with Marc, however consider an alternative reason for the Q manual.

Besides satisfying the ISO requirement, the Q manual should reflect how you run your business. Instead of substituting "ABC Company will" for "the supplier shall", write a manual that is useful as a marketing, training, supplier, future employee, etc manual. As a for instance, have a section called Marketing. Describe what marketing does, including that they review orders/contracts before accepting them. Write procedures for: Issuing Quotations, Negotiating Contracts, Order Entry, etc. Include a cross reference matrix in the back of the manual that says ISO 9001 Element 4.3.1 is covered on page 3 of the manual. You now have a manual and procedures that the company can use for something other than just meeting the ISO requirement. In addition, when ISO 9000: 2000 is finally approved, you do not have to rewrite the entire manual. Change the matrix and add/revise a procedure or two.
 
S

scottknutson

#4
Thanks Marc and Rick. You confirmed my reasonings. We're pretty comfortable with the manual that we've created, but a lead auditor who reviewed the manual said there would be a nonconformance for not talking to each shall.

We're going to move forward with the approach we've taken.

Thanks again,
Scott
 
#5
So, for the quality manual, is it better to translate the "shalls" by "we are/have*/have been"? or is ok to copy the standard as it is just changing the "supplier" part by "us"?

Thanks!
 
L

Laura M

#6
I personnally hate quality manuals that read like the standard with "the supplier shall" to "company ABC does." Makes me wonder what the company knows at all about the standard. It may be short and sweet, but make it meaningful.
Put it in company lingo, use department names instead of "the company" and reference procedures for more detail.
 
C

CJacobsen

#7
The section in the FDIS that covers the Quality Manual is 4.2. The manual itself is specified in 4.2.1b and specifically in 4.2.2.

"4.2.2 Quality Manual
The organization shall establish and maintain a quality manual that includes:
a) the scope of the quaolity management system, including details of and justification for any exclusions,
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quaolity management system.

Almost the same text as Marc stated above. But found in different location in FDIS.
 

barb butrym

Quite Involved in Discussions
#8
A quality manual should belong to the company it represents... An auditor may be lazy and want a manual to mirror the standard to faclitate the review(after all..the document review is done on non billable time typically....so obviously auditor friendly would please the auditor) If the manual addresses the shalls, the auditor must accept it. if you want to, you can do a real quickie and say "XYZ company addresses all the requirements of the ISO 9002 standard in detail through its standard operating procedures" then reference them in a matrix, add the policy org chart etc...WALA.....NOT recommended obviously.......BUT meets the requirements. Bottom line, the manual should meet the needs of the company as well as describe the system and address the shalls
 
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