QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do?

[JaneB]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

Wow...the requirements are irrelevant...is that why auditors write so many nonconformities when the "irrelevant requirements" are not met? How can employees know the requirements if they are not spelled out at some level.

In actuality, the standard requires that all requirements are met - those of the standard, the organization, and legal and other requirements - all must be met.

Come on, Helmut. I know that Paul knows what you've spelled out as '101' in your second paragraph.
And I would have thought that you know he knows too - you've been around the forum long enough to see that Paul knows this stuff inside out and backwards (and probably while whistling Dixie to boot).

I'm sure it's just a minor error of expression/wording - probably his meaning was something along the lines of 'it's not relevant to include all the wording of the specific requirements (ie, regurgitation) in a manual' - a topic that has been debated exhaustively in the Cove. And I'll bet a lot of $$ that he did not intend to say nor even imply that requirements of the relevant Standard don't need to be met.

 

[JaneB]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

If you approach the development of a QMS from what the business needs in order to consistently produce product that meets customer requirements, you only get around to looking at ISO 9001 after you have a capable system and want independent certification. ..... It does not say that ISO 9001 can be used to develop a QMS.

? I don't follow this logic (which actually simply sounds focussed on QA to me rather than quality management).

The Standard actually says more:

This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

I do agree that many if not most organisations go for certification after they've reached a certain point.

But as for ISO 9001 'not saying' that it can be used to develop a QMS... sheesh. Suggest you re-read the title of the Standard - it specifies minimum requirements for a QMS. Why on earth you think one could not or would not use it to develop a new system? The clients I have who did do this (ie, use ISO 9001 to develop their QMS from scratch) didn't have this 'problem' you apparently see.

Do you need to have everything written in it? I don't.

 

[Pennington]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

Hi Jane

I don't follow this logic (which actually simply sounds focussed on QA to me rather than quality management).

My premise is that the management system is the means by which the organization achieves its goals and satisfies its stakeholders. One of these goals is to consistently produce product that satisfies customers. So what I am saying is that when this system has been developed and shown to be capable of producing product that satisfies customers, you can have it assessed against ISO 9001.

If you look at clause 0.1 of ISO 9001:2008 it says "This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization's own requirements."
This does not say the standard can be used to develop a QMS. It only says is can be used to assess an organizations ability.

ISO 9001 specifies requirements for a QMS where an organization needs to demonstrate it has the ability to consistently provide product etc... Therefore it does not include everything and organization needs to do to operate effectively in its environment.

In the 1987 version of ISO 9000 it recommended you firstly develop a system to meet ISO 9004 then select the appropriate assessment standard ( 9001, 9002 or 9003) Even though this is no longer recommended in ISO 9000:2005, ISO 9001 was never intended to be a design standard. It has always been an assessment standard - hence the statement in the Introduction.

I'm sure there are other interpretations but it emphasis my point that it is clear that ISO 9001 is unclear don't you think?

 

[Peter Fraser]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

If you look at clause 0.1 of ISO 9001:2008 it says "This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization's own requirements."
This does not say the standard can be used to develop a QMS. It only says is can be used to assess an organizations ability.

I'm sure there are other interpretations but it emphasis my point that it is clear that ISO 9001 is unclear don't you think?

I agree. Whatever the standard says or doesn't say, many people have used it as the basis for their system structure, which is why there were so many "20 sections" systems with the previous version - now seen as missing the point.

 

[bobdoering]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

The reason no one looks at it is because it does not say anything. If you put meat into it, then people will read it.

This is an interesting point.

Ponder this:

If you had an instruction manual for something you personally cared about - let's say your car - would you read it? Would you read it cover to cover? Would you read it more than once - cover to cover? More importantly - do you believe than everyone that gets such a manual reads it cover to cover? If not, why not?

The next point is, then, when would you read it, and what information would you expect to get out of it if you did? What is 'meat' to a user - not an auditor. This is not to demean what the auditors are looking for, but rather systemically are we missing the point of the quality manual by essentially writing them for the wrong audience.

I think systemically we are getting trapped into writing a QMS instruction book with the Standard - and its interpreters (auditors) - as the audience, not the end user. The OP's boss may be conceptually correct - but unless the external system embraces that concept, he will be out of luck.

 

[JaneB]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to


Pennington,

I think the point you're wanting to debate belongs in a new/separate thread. To continue to debate it here risks further derailing this thread.

 

[Paul Simpson]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

Thanks to JaneB for leaping to my defence!

IMHO the purpose is to communicate the requirements, expectations and policies. Please, don't write a manual because the standard says so.

Now there are many threads on the Cove and posts that say the only reason for a manual is because the standard says so ... not a view I subscribe to as the second bullet in my list says:

Why?

I have said it before and no doubt will say it again. IMHO the requirements of ISO 9001 (or any other management system) have no place in a document intended for people working in the system. The manual has two purposes.

1. To fulfil the requirements of the requirements standards (i.e. 4.2.2)
2. Give an overview of the management system

If you state a commitment to meet the requirements of the standard in your policy, then you need to communicate what those requirements are. My point is you can do it in procedures or a manual or wherever.

I would never recommend a commitment to complying with the requirements of any particular standard in a policy. Apart from anything else, as has been seen in other threads it means you have to reissue the policy when a standard is reissued.

In my example, I am not "regurgitating the standard. But, my template begins with it (actually I use ISO 9004), and I rewrite it into an easy to understand handbook which expalins what is required.

Again .... why?

One has to define the format before one begins to write. The number of pages won't be determined until I finish, and is irrelevant. As far as wadinig through the wheat and chaff...we make that a hyperlinked table of contents and an index. Very easy to go directly to the section you need.

That was the reason for my original question. You said it was going to be 33 pages ... how did you know this before you started?

A cross reference would also work. But, haven't you seen people fumbling to find something, opening this docuemnt and that, before finding the info they seek. It's a lot of work.

I have seen the behaviour you mention - only when an individual doesn't know their system very well. Having it all in one document has the same potential problems.

Wow...the requirements are irrelevant...is that why auditors write so many nonconformities when the "irrelevant requirements" are not met? How can employees know the requirements if they are not spelled out at some level.

Now, Helmut, you forgot to use the :sarcasm :emoticon. Again if you take my quote out of context ....

.... as Jane explained the irrelevant bit is putting the requirements in your document. That is not a requirement )) of the standard.

Employees can understand very well the controls required for any process they are involved in when you explain why the organisation is doing things a certain way.

Telling them it is also required by the standard doesn't actually help their understanding any (IMHO).

In actuality, the standard requires that all requirements are met - those of the standard, the organization, and legal and other requirements - all must be met.

Agreed

 

[JaneB]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

Now there are many threads on the Cove and posts that say the only reason for a manual is because the standard says so ... not a view I subscribe to

Me neither. It's such a myopic and limited view, which fails the most essential importance of understanding.

I do wish people would go further, and ask themselves: why would or does the Standard require a manual (/documentation)? Why is the requirement in there? Because that's the really important point.

And then writing a manual that just repeats or regurgitates the requirements of the Standard itself compounds the original error.

 

[Yarik]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

I do wish people would go further, and ask themselves: why would or does the Standard require a manual (/documentation)? Why is the requirement in there? Because that's the really important point.

And then writing a manual that just repeats or regurgitates the requirements of the Standard itself compounds the original error.

I think some hints about the reasons of requirements imposed on Quality Manual can be found in ISO/TR 10013. In particular, this document discusses:

• the possible purposes of a Quality Manual,
• its possible content (besides the elements mandated by ISO 9001), and
• its possible structure

Of course, these are all just guidelines and can be interpreted and followed very differently by different people, but when I read them, I definitely do not feel guided in the direction of "QM should be for auditors only".

Here is some fragment from ISO 10013:2001 that may be pertinent to this long thread:

4.4 Quality manual​

...

4.4.8 Quality management system description​

The quality manual should provide a description of the quality management system and its implementation in the organization. Descriptions of the processes and their interactions should be included in the quality manual. Documented procedures or references to them should be included in the quality manual.​

The organization should document its specific quality management system following the sequence of the process flow or the structure of the selected standard or any sequencing appropriate to the organization. Cross-referencing between the selected standard and the quality manual may be useful. ​

The quality manual should reflect the methods used by the organization to satisfy its policy and objectives.​

The colored highlights are mine: the colors reflect my personal attitude towards the highlighted fragments.

 

[ralabaf]

Re: QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to

I suppose that with big enough paper and small enough font it would be possible to get most things onto 4 pages of paper.

I don't want to go back over the origins of the thread (and might not live long enough to read through every post), but I wonder what the motives of the "Boss" might have been. If I was a QMS novice that had done a bit of googling and found a selection of Quality Manual ranging in length from 4 sides upwards, I'd be asking my Quality Manager for something in the low page range.

The length of the Quality Manual falls into the "horses for courses" category in my opinion and will, and should, vary from organisation to organisation. Perhaps, even with time and the maturity of the QMS.

There's little point in having a 50-page manual if nobody will read it because there are plenty of other more relevant and useful documents already established in the organisation. Equally, there's little point in having a 4-page version that sits in complete isolation.

Our current Quality Manual is 5-pages long, including a snazzy front cover and a page of amendments history. That leaves three pages of detail: the first two meeting the technical requirements of ISO 9001 and also recording my delegated authority to "own" the system documentation; the final page is a Plan-Do-Check-Act diagram (based on the one in Clause 0.2 of 9001) superimposed with our main processes, thus showing the "interaction between the processes of the QMS".

I took this approach following a hint from our external certifying auditor and my own research into whether anybody ever referred to the previous 35 page Quality Manual (they didn't - we have processes and procedures up the ying-yang many of which are cascaded to us from higher or external organisations and outside our unilateral control). But the A3 diagram that depicts the interaction of the processes has proved very popular (often in PowerPoint presentations to owners/stakeholders/customers) and is to my biased mind a good picture of how we deliver business.

As I say, horses for courses, but nearly always tempered by the comfort-feeling of someone high up that might have a personal view on what they want their organisation to have in place.

Which reminds me – the very new top-boss hasn’t seen it yet. Must remember how to remove “archive copy” watermarks …..