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

[brandwood]

One size fits all?

I find another, practical reason for keeping the manual short.

The quality procedures and instructions can contain a lot of commercially sensitive information. However - one very useful function for the quality manual is as a form of corporate cv (resume for the americans here ).

If you take the approach of keeping it short, including some well written overview of what the company is about, its product lines, objectives and values (all of which lay the foundations for objectives and associated procedure documents in the system to meet ISO 13485) - then what you get is a document that can be published freely - and given to your customers and potential customers as a marketing tool. You can't do that if its large and includes all sorts of technical detail which you may not wish to disclose to the wider world and which would not make for exciting reading to customers.

Arthur

 

[JaneB]

When it comes to a quality manual, one size does not fit all. Different organizations might have different approaches to their quality system.

Couldn't agree with you more Sidney.

No, one size does not fit all. The 2 keys questions perhaps are: does the manual suit the organisation? Does it achieve the organisation's purpose?

I'd always rather have doco that 95% of people have read than 5%, and I've found that keeping things short, clear and simple go a long, long way toward achieving that.

But what would suit, say, a 10-person consulting business couldn't and wouldn't suit a multinational, global engineering firm with hundreds or thousands of employees. Purpose and audience reigns. In the former, you could have far fewer policies, because 'top management' is infinitely closer to their personnel. In the latter, you have to represent far more things in the written form, and sometimes in quite a lot of detail. Horses for courses... it always comes back to the situation, the purpose and the audience. I'll always stay with my approach of keeping it as short as is possible (note: as is possible) but I wouldn't, for example, be comfortable with anyone approaching even a small construction project without what can be quite a wad of documentation, most of which is entirely necessary!

BUT I also think one can encompass both approaches: for example, give the overview (keeping it simple) at the high level... give more detail only as and when needed. No one wants to read 30 pages, for example, to answer a single basic question. And in these days of online documentation, hypertext, hyperlinks, help files, etc. etc. there's little excuse to require them to do so.

Final point: I wonder if everyone means the same thing by 'quality manual'? Overall, I understand the term to mean the totality of written documentation (whether that be in paper, online, electronic system, maps, flowcharts, etc). But in other emails some people appear to be meaning just the top level manual, what one might call the policy type manual. And at times, that includes some of my own, just to be confusing!!

 

[Laura M]

Operational Definition

Final point: I wonder if everyone means the same thing by 'quality manual'? I understand the term to mean the totality of written documentation (whether that be in paper, online, electronic system, maps, flowcharts, etc). But some people appear to be meaning just the top level manual, what one might call the policy type manual.

I think you hit the nail on the head. As I've read this thread, I've been thinking the long manuals probably include alot of the operating procedures, while some of us supporting the short ones, it's strictly the policy manual. The procedures are referenced but not included.

 

[amanbhai]

Boss wnats a 4 page manual

I have created a quality manual for our company which is 40 pages. It simply covers every element with a paragragh or so, except for Management Responsibility is covered in the manual instead of a procedure.
My superiors feel the manual should only be 3 or 4 pages long. Most of this reasoning is from different companies who have claimed to be certified.
Am I wrong in assuming a 3 or 4 page manual would not be adequate, and what exactly would be accurate?
Thanks, Dawn

this thread was first published in Novemeber 1998. i think that's very interesting since the new ISO 9001 standards are in place.
One thing that I wanna add is that according to ISO 9001:2000. The size of the documentation depends upon the nature of your work & the competence of your personnel.

 

[Antonio Vieira]

I still have my opinion:
If the Quality Manual only serves to get registration, the best you have to do, is throw it away!
The QM has to bring added value to the organization.
I’ve made Quality audits in witch I need to ask the auditee some extra information, generally procedures, because the Manual only states a little bit more that the organization’s name...
Any QMS I’ve made, before the audit the Registrar only asks for the QM!
There we can find everything about the Quality System you need to know to prepare the audit.
Of course the size of the Manual depends on the kind of company, but a small company can have a consistent and substantial QM. If it’s well done!

About the know-how that can be a secret of the organization, I’ve never seen also any secret in any QM..., the place to put “secrets” are specifications or procedures.

 

[wilsonmm]

I’ve made Quality audits in witch I need to ask the auditee some extra information, generally procedures, because the Manual only states a little bit more that the organization’s name...
Any QMS I’ve made, before the audit the Registrar only asks for the QM!
There we can find everything about the Quality System you need to know to prepare the audit.

This touches slightly on an area that, as long as this thread is becoming, hasn't really been discussed which is the impact an audit can have on the size of the quality manual. My program has been audited six times by ISO auditors. I've never had a non-conformance, but always get 3 to 5 OFIs which usually state "you could be clearer about...." And, in answering each OFI, things are added to the quality manual and it continues to grow in size.

Sure, there have been times we disagreed with the recomendation of the auditor and made no changes, but most often each OFI led to a new paragraph, chart or both, and the manual grows.

I thinks sometimes when an auditor is paid to inspect your program and you pay for his time, travel, lodging and expenses, they feel compelled to report "something" to justify the expense - - and the manual grows.

Just MY opinion.

 

[little__cee]

I agree 100%

I thinks sometimes when an auditor is paid to inspect your program and you pay for his time, travel, lodging and expenses, they feel compelled to report "something" to justify the expense - - and the manual grows.

I agree 100%!!!

 

[JaneB]

I've never had a non-conformance, but always get 3 to 5 OFIs which usually state "you could be clearer about...." And, in answering each OFI, things are added to the quality manual and it continues to grow in size.

Sure, there have been times we disagreed with the recomendation of the auditor and made no changes, but most often each OFI led to a new paragraph, chart or both, and the manual grows.

It's a little hard talking in generalities... although I understand the problem. But before adding anything or increasing size, I'd still ask: does the manual suit the organisation? Does it achieve the organisation's purpose?

Perhaps it might help to to stop thinking of the quality manual as a single entity, and thus ask: does the collection of documentation that sets out/describes/whatever our implemented system suit us? Does it achieve our purpose?

Auditors are human too (other opinions to the contrary notwithstanding I've met good, bad, and ordinary ones, & on a couple of memorable occasions, appalling ones. But no matter which, I personally would not add anything to the system, which includes the manual or any other document, unless I was clear about which section(s) of the Standard the auditor was referencing, and precisely what the lack of clarity was. What's the effect? What is the auditor attempting to achieve? How do they think that making this change will improve things?

Any external auditor is an outsider - meaning they give you an outsider's perspective. This can be very useful or valuable at times. And at other times, not. They are there to test the system, to 'challenge' it, if you like. It's their job.

But OFI or not, you choose what to do about it. And if I had audited an organisation, then returned for a later audit, and followed up, and the client company said, 'well, we considered your point, and this is what we did (eg, asked x managers/personnel... tried it out with 5 new employees, etc etc) and decided it was quite satisfactory/worked well as it is, so we closed it off as not required' then I (& I think any other reasonable auditor) would agree with that.

It's your quality management system, and *your* organisation. Not the auditor's. I do not think it is worthwhile to do things only because the auditor said. In fact, I think it's usually a very bad idea.

 

[Wes Bucey]

Let me add there are other places to add documentation (Procedures, Work Instructions, Records) than in the Quality Manual, which I view as simply an "overview" of the organization's Quality System. While it may be true "the Devil is in the details" - that doesn't mean the details have to be in the Quality Manual.

 

[AndyG]

We are audited by a well respected british accreditor and a lead autitor suggested a 5-6 page manual. I have a copy of doc, will post latter on