Quality Manual Content - Extended debate - Updated Quality Manual for ISO 9001:2008

Re: Updated Quality Manual for ISO 9001:2008

AndyN said:

You may wish to make your 'Be Gentle Statement' in caps and bold too!

Well, I fell asleep reading it, because I've read the ISO standard before and that's what it does to me! Your description of the company is nice but a bit too long (ever considered a picture of the shop floor as a background?) then you can list equipment if you really need to!

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Let me ask you this - Would an auditor reject it, and if so on what grounds?

It's one thing that a manual is not what some of us would 'like to see', but rather if it complies with the requirements of the standard.

Re: Updated Quality Manual for ISO 9001:2008

Marc said:

Let me ask you this - Would an auditor reject it, and if so on what grounds?

It's one thing that a manual is not what some of us would 'like to see', but rather if it complies with the requirements of the standard.

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Plenty of auditors will accept it, of course. That's been the way for nearly 20 years! My position is that that's not the true test - auditors accept all kinds of things they shouldn't!

I'd put it to the management team to describe for me their relevant sections of the manual to see what a meal they made of it..........I'd be interested if anyone can speak to 'product realization' or 'status and importance' or 'competence, awareness and training' or any of those things.....

Practically speaking, since ISO is a requirement, I see no value in restating it in a manual! Requirements are to be met, not restated verbatim! Now, if the manual said 'this is what/how XXX does (for example) scheduling of audits, then I'd say 'great'! But at that point you're probably getting into procedure level stuff - which in a small company could be in the manual, agreed. But that's not the case here, when it probably could be.

I recognize that there are those who don't have a problem with a 'standards based' manual and we'll never agree. To me it's like family house architecture. The building code has to be incorporated into the house's design, regardless of what it looks like. As a result, most houses can be designed to look quite different, but all meet code! A manual like this one makes all the houses look the same - ugly!

Re: Updated Quality Manual for ISO 9001:2008

Marc said:

Let me ask you this - Would an auditor reject it, and if so on what grounds?

It's one thing that a manual is not what some of us would 'like to see', but rather if it complies with the requirements of the standard.

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The OP didn't specify any criteria, so I chose my own - trying to be helpful. There are two specific nonconformities in the manual that would cause me to reject it:
- The manual doesn't describe the interactions of the processes (4.2.2c)
- The quality policy statement doesn't address continual improvement (5.3b)

Re: Updated Quality Manual for ISO 9001:2008

JaneB said:

This isn't something I'd expect to see in any quality manual at all.

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Although not required to be in the Quality Manual, Quality Objectives often are. I include them in all the manuals I write. Nearly all the manuals I encounter during CB audits include them include them.

Since it is not requirement, it certainly could not be written as a nonconformance (unless your documentation says they will be there).

Re: Updated Quality Manual for ISO 9001:2008

dQApprentice said:

Also, I don’t see the established quality objectives at relevant functions and levels.

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JaneB said:

This isn't something I'd expect to see in any quality manual at all.

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Big Jim said:

Although not required to be in the Quality Manual, Quality Objectives often are. I include them in all the manuals I write. Nearly all the manuals I encounter during CB audits include them include them.

Since it is not requirement, it certainly could not be written as a nonconformance (unless your documentation says they will be there).

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I might be wrong, but I don't think that Jane was objecting to having objectives in the manual, but rather to having them cited for "...relevant functions and levels." In other words, dQApprentice seems to be expecting more detail than the standard even requires for objectives in general, let alone in the QM.

Re: Updated Quality Manual for ISO 9001:2008

Jim Wynne said:

I don't think that Jane was objecting to having objectives in the manual, but rather to having them cited for "...relevant functions and levels."

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Correct, Jim. Thanks for reading and understanding what I actually wrote.

Re: Updated Quality Manual for ISO 9001:2008

Just wanted to chime in here... I have been reading this thread over the last hour and am amazed at the passion, varying viewpoints and depth of the answers. I'm glad I joined the community here!

My background: I started with the Department of Defense back in the late 70s, and cut my teeth on Mil-Q-9858A, Mil-I-45208, and, Mil-C45662. We were basically assigned as quality assurance 'auditors' for a large contractor on Government projects. Their quality manual was several (like 12 or so) 3" 3-ring binders, and was extremely difficult to navigate. They had 4 levels of documentation as well as an entire manual of "workmanship standards".

I was one of the Government auditors hoping that the DoD would adopt ISO when it first came out. The problem that my friends who stayed with government have now is that ISO lacks the 'teeth' that Mil-Q used to have (I'm not sure what they mean by that but I am guessing that the fact that it was less attuned to generalities meant it was easier to audit to).

Anyway, as I am now on my 4th company and a new chance to implement an ISO system, I am indebted to y'all for your comments and views. (yes - I am in Texas).

I am hoping to write and implement a system compliant with 9001, 29001 and API's Q-1. I Am reviewing the standards now, pulling out the sections to my idea board and starting to map the company's processes as they exist.

Typically in the past I have written my manuals to reflect the standard's requirement and then answer the "how do we comply with that requirement" question from a policy level (the high-level how, why and who). The 'why' seems an important step as it can also describe reasoning behind interrelated processes, as well as reasoning behind business decisions - seems appropriate in the top-level 'policy' manual.

I then refer to the Quality Operating Procedure that details the 'detailed how, when, who and where' and other specifics. Does that make sense? My earlier documents have withstood audits well, and have given the companies a clear path they can follow.

Anyway - I'm sure I'll be hearing more from y'all and just wanted to send my appreciation!


Rick

Re: Updated Quality Manual for ISO 9001:2008

rkasparek said:

...Typically in the past I have written my manuals to reflect the standard's requirement and then answer the "how do we comply with that requirement" question from a policy level (the high-level how, why and who). The 'why' seems an important step as it can also describe reasoning behind interrelated processes, as well as reasoning behind business decisions - seems appropriate in the top-level 'policy' manual.

I then refer to the Quality Operating Procedure that details the 'detailed how, when, who and where' and other specifics. Does that make sense?

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Personally, I like that kind of approach, and use something like it myself. Some think a 2 page manual is a goal, I prefer to write a manual that says what our policies are. Then, write whatever additional instructional documents you feel would be beneficial.

Good luck to ya...

Re: Updated Quality Manual for ISO 9001:2008

Wow, I thought this thread was eaten by wolves! I am now upgrading the original manual to include 14001. Any opinions or suggestions?

KISS
MsHeeler

Re: Updated Quality Manual for ISO 9001:2008

MsHeeler said:

...I am now upgrading the original manual to include 14001. Any opinions or suggestions?

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Good for you. The two standards share many common administrative requirements and clauses. Combining those could be useful and pretty straightforward. Best wishes to you...