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

J

JaneB

#2
Re: Updated Quality Manual for 9001:2008

I have had one auditor that really liked it, one that really hated it, and one that didn't even look at it.

Tell me if you find any mistakes.
To me, it's a mistake to structure and write any manual that just regurgitates the Standard, and gives zero idea whatsoever of what your organisation actually does and how.

If you're fixed on this approach, you could simply replace the entire thing with just the Policy, 4 objectives and a matrix of the procedures and which clause you intended to address with them. That could be done on 1 page, because it's really all these 12 pages contain.

Sorry, but I'm with the auditor that really hated it, and can quite understand why another auditor didn't look at it - why would one?
 
J

Jeff Frost

#3
Re: Updated Quality Manual for 9001:2008

I coinsure with JaneB. The best manuals I have reviewed are just 4 pages long based on PDCA from 0.2 of ISO 9001:2000 using the process approach/flow charts. Your actual operational procedures should address each requirement of the clause not the Q Manual.

Look at what is required by Clause 4.2.2 of ISO 9001:2008

a) Scope of the QMS, including details of and justification for exclusions
b) Documented procedures established for the QMS, or reference to them (List of procedures will work here)
c) Description of interaction between the process of QMS (Flow Chart can show this)

By the way you might want to remove your company name from the header.
 
#4
Re: Updated Quality Manual for 9001:2008

MsHeeler - you're not going to like this but........ 2 mistakes!

1 - doing a manual which copies the standard - no use to management!

2 - using auditors to judge if they like it or not! Not their job! It either complies or it doesn't. Anything else is simply an opinion, which is what you came here for. If the auditor who didn't like it was 'on to something', then he should have asked your management to 'speak to' its use. IMHO, it would have been very obvious that they would not have been able to articulate any 'ownership' of the verbiage in there - The good Lord knows even we QA folks have widely differing version of what it says.

I also read your other posts about redoing your manual and procedures. It's clear you are proud of your achievements, and you should be! However, I think (to coin a phrase) "you're looking for love in all the wrong places".

It's not what we think about it, findings errors, writing to meet the 2XXXX version of the standard or keeping an auditor happy. It's the value to your organization; operationally, and not just maintaining certification!

I don't mean to be blunt or unfeeling - just being objective, as you requested.
 

Marc

Captain Nice
Staff member
Admin
#5
Re: Updated Quality Manual for 9001:2008

I'm going to jump in here and make a comment. I see most people here are saying that making your quality manual like the standard is a problem. For example, AndyN says "1 - doing a manual which copies the standard - no use to management!". I say poppy cock. The structure of your manual is independent of it's use to management or anyone else in the company, and Andy and others who issue statements like this are not doing anyone any favours. Just because a quality manual is like someone else suggests (e.g.: "The best manuals I have reviewed are just 4 pages long"), it doesn't mean the company with such a manual is more likely, or less likely, to follow their documentation and for it to provide value to the company. I'm surprised some people here are implying that is the case. I've seen companies with really neat-o short quality manuals that didn't follow their procedures, and it didn't make it more useful to anyone in the organization than if they had an 'it looks like the standard' quality manual.

Jane said: "To me, it's a mistake to structure and write any manual that just regurgitates the Standard, and gives zero idea whatsoever of what your organisation actually does and how." I disagree in that when you use the 'it looks like the standard' approach what the organization actually does and how is found in the documents referenced in the quality manual. Couple that with a document which illustrates the interaction of processes and how the company works, what it does, etc., is evident.

I started doing implementations almost 18 years ago and that is how we did them then in large part because auditors in the early days would ding you if you did not address every sentence in the standard whether it applied to you or not. In addition, the standard's structure provided a backbone for companies to follow and 'hang related procedures on' by reference.

I am still in touch with a number of clients from the old days. None of then has changed their manual significantly. The 1994 to 2000 change was cause for some minor revisions, but these companies are still using their old, basic "it looks just like the standard" manuals. Heck, I had some small clients whose quality manual included every procedure they had in it. They had simple processes and it was easiest to have one book rather than a number of procedures and a quality manual.

Since the 2000 revision of ISO 9001 I have seen more and more people jump on the idea of short manuals and gimmicks. Unfortunately, I have also seen many people comment as Andy did as if the structure of a quality manual is a big deal. It simply isn't.

I WILL say that the one thing I do expect is a flow chart or other representation of the interaction of processes. But even this is not really 'new'. Oh, people SAY it's new, but I was doing this with clients in the early 1990's. I don't know how else to tie everything together. Back when I was doing that, I remember an audit back in 1994 of a client which I got to flow chart all their procedures. The auditor did not, at first, accept them as procedures. Today, it's a popular way to represent systems and processes.

I have also found that for many companies, especially small companies, an 'it looks like the standard' quality manual serves to 'remind' them of the requirements of the standard.

If the structure works for you, use it. Just because there are other ways to structure a quality manual doesn't make one way the 'correct' way.
 

howste

Thaumaturge
Super Moderator
#6
Re: Updated Quality Manual for 9001:2008

I feel like I'm in the middle ground from what I've seen posted. I agree with some points of what each person has said. Of course opinions are like armpits - most people have a couple, and some of them stink. Feel free to let me know if mine are the stinky ones... :notme:

Here's my take: I don't completely like it - yet. I find little value in just rewriting the standard in the manual. However, I believe it can be a good starting point if you then add some meat by including methods the company has chosen to do the things mentioned.

The quality manual, like any document, should be written for the intended users. Generally I find that customers and auditors (internal and external) refer to it most often. Management also refers to it to ensure that when changes are made to the system, that they don't conflict with requirements. People throughout the organization may refer to it when they want to see the big picture of the system, or what policies have been established.

Customers want to see how your system takes care of their needs. If you have a 2 page manual, it may not inspire confidence that your system has the basic building blocks of a truly effective system. They want to know that you know how to plan, implement, and control the processes that will give them what they need.

Auditors want to know how you've met the requirements of the standard, and if your system is effective in achieving your objectives. If you've addressed all of the requirements of the standard in the manual, along with some details of the "how to" then auditors can use the manual as a guide to help them find the evidence they need. Internal auditors don't even have to refer to the standard any more during internal audits. They can audit the organization against their own requirements instead of a generic external document written by people with no understanding of their business.

Management and other users should be able to see in the manual how the was system was designed to work. It should show how the processes of the system interact, and at a high level what policies and methods have been established to maintain and control the processes. Nobody usually cares what the structure of the manual is, so there's nothing wrong with putting it in the same structure as the standard.
 

Marc

Captain Nice
Staff member
Admin
#7
Re: Updated Quality Manual for 9001:2008

This is a bit off topic, but... The biggest failure mode I have found is where no one in a company can adequately explain the interaction of processes, their quality manual, its contents, how the company meets the requirements of the standard and how everything fits together and works.

I've seen so many quality manuals over the years I'm saturated with different quality manual structures. I don't see the structure as important when compared to whether someone in the company really understands, and can explain, what they have.

NOTE: I looked at the quality manual and I don't have a problem with it at all. I posted what I did above because of comments like AndyN's where he says "1 - doing a manual which copies the standard - no use to management!". I feel that's simply wrong. I do invite Andy to explain how he knows it is of no use to management. I have an awful lot of clients who have a quality manual which is very much like the one here and have for years. They're still passing their audits and quite a few breeze through every audit these days with 0 nonconformances. Management knows what they need to know, they can explain / discuss their part in the systems that are applicable to them.

I can understand it if someone says "I prefer..." a certain format, but my hope is the OP doesn't feel that the manual should be changed to something some else likes better. If I was auditing the company I would have no problem with the manual the OP posted. My concern would be that the person responsible could explain it, and how everything fits together.

It seems more people want to opine on the structure than on what the OP asked - Are there any errors?
 
J

JaneB

#8
Re: Updated Quality Manual for 9001:2008

I say poppy cock. The structure of your manual is independent of it's use to management or anyone else in the company
Poppy cock, huh? I contend that if a manual (or any other document for that matter) actually contains useful and comprehensible information (eg, good content and a structure that assists understanding/finding of info) then it is or will be useful (& not just to management, as howste reminds us).

I've seen companies with really neat-o short quality manuals that didn't follow their procedures
OK. I've also seen companies who had 'one-size-fits-all-regurgitate-the-Standard manuals' and they didn't either. How is this relevant?

I started doing implementations almost 18 years ago and that is how we did them then in large part because auditors in the early days would ding you if you did not address every sentence in the standard whether it applied to you or not.
Yeah me too. But just because 'we did it then and it worked', does that mean it's good? Or that we shouldn't aim to do better? I discarded them because I found something that worked better and gave more value. In my experience, no one (with the possible exception of the writer and auditor) actually understood, let alone used that kind of manual. I recall - vividly - the MD of a successful small boilermaking enterprise who picked up one of those that I'd written, read for a short while and then dropped it on the desk looking rather ill, and said something rather along the lines of (expletives deleted): What on earth does that actually mean in English??

I was fortunate enough to come across a couple of really good auditors from CBs, with whom I had a lot of very productive discussions. After which I started writing them in 'plain English' and using language that the people in the company actually used. And watched their eyes light up as they really "got" that this stuff could make sense to them, rather than require a degree in 'quality speak' to comprehend. And oh yes, they got and maintained certification of course.

As you can see, I feel passionately about clear communication. :D It is so easy to conceal, or to obfuscate and confuse with language that is too 'technical', too full of jargon and just not clear. The Standard has some excuse - written by committee, dependent upon consensus and needs to be readily translatable to/from many different languages.

Unfortunately, I have also seen many people comment as Andy did as if the structure of a quality manual is a big deal. It simply isn't.
Big deal? No, not if everyone wants to structure, manage & run their organisations in exactly the same way.

Whatever happened to a process approach? Or an authentic voice?

I have also found that for many companies, especially small companies, an 'it looks like the standard' quality manual serves to 'remind' them of the requirements of the standard.
Good point. I haven't.

If the structure works for you, use it. Just because there are other ways to structure a quality manual doesn't make one way the 'correct' way.
Yes, I agree with you. There's no such thing as only one way. :D

Like Howste says, doing a manual by copying the Standard can be a starting point. But only a starting point.

Finally, re. my raising the issue of unique content = 2 pages (at most). Please don't read as arguing in favour of a '2-page manual'; I merely commented on the quantity of unique content in the manual. (But for the record, I do not believe any organisation can effectively manage itself with a '2-page manual' or even a '4-page manual'. :nope: The argument about length, again, is a different topic, and exhaustively discussed elsewhere.)
 
J

JaneB

#9
Re: Updated Quality Manual for 9001:2008

This is a bit off topic, but... The biggest failure mode I have found is where no one in a company can adequately explain the interaction of processes, their quality manual, its contents, how the company meets the requirements of the standard and how everything fits together and works.

I've seen so many quality manuals over the years I'm saturated with different quality manual structures. I don't see the structure as important when compared to whether someone in the company really understands, and can explain, what they have.
:applause:
Yes, I am 100% in agreement with you here. I even agree with what you say about the structure not being 'as important' in this post, whereas your previous one was rather dismissive.
 
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J

JaneB

#10
Re: Updated Quality Manual for 9001:2008

:topic:

Of course opinions are like armpits - most people have a couple, and some of them stink. Feel free to let me know if mine are the stinky ones... :notme:
:lmao:

Made me laugh - thank you!

Hmm, perhaps we need a deodorant icon? :D
 
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