How long can my ISO 9001:2008 Quality Manual be?

[Big Jim]

Re: Quality Manual 9000:2008

Huh? Not sure where you got this from. No one (to my mind) is arguing you 'don't need a quality manual'. Peter said one didn't need a separate manual - and is debating the form or medium that might take (and I'm sure is familiar with 4.2.2).



Peter, No, of course you don't need a 'separate' document, nor do you need something that is specifically titled a 'quality manual', etc etc. And yes of course one can use electronic solutions, such as the product sold by your company, other companies' products or house-built solutions.

I know this, you know this and it is explained by ISO in places such as 9001: (0.1 and Note 3 to 4.2.1), and the definition of a document and a quality manual in ISO 9000 (3.7.2 and 3.7.4), with their attendant Notes. And I've recommended, provided or created many an electronic solution.

But somehow it's still easier to write 'manual' and 'page' and speak 'hardcopy' language than have to employ clumsy and verbose expressions such as "hardcopy manual and/or alternative solution such as collection of documents published on an internet site/intranet/other application" etc. (I sometimes think it's no wonder the language in Standards is as it is and it takes so long to update them)

I'm well aware that documentation can be in any form or type of media as stated in note 3 of 4.1.

That doesn't get around the wording of 4.2.2 "The organization shall establish and maintain a quality manual . . . "

This sure looks like he is saying a quality manual isn't needed:

Originally Posted by Peter Fraser

"Or go even further if you can and don't produce a separate "manual" at all. So long as you have defined (perhaps electronically) those things that it needs to cover as part of your system description, and that you don't need a "document" that you can give to someone, it is only the wording of the standard that implies that you must create a separate document. You don't."

If he is trying to say the quality manual can be electronic I don't have a problem with that. Saying one isn't needed is absolutely wrong.

 

[Peter Fraser]

Re: Quality Manual 9000:2008

I'm well aware that documentation can be in any form or type of media as stated in note 3 of 4.1.

That doesn't get around the wording of 4.2.2 "The organization shall establish and maintain a quality manual . . . "

This sure looks like he is saying a quality manual isn't needed:

If he is trying to say the quality manual can be electronic I don't have a problem with that. Saying one isn't needed is absolutely wrong.

Jim

To my mind there is no reason for the standard to pick the few things which it says should be included in a "manual" (a term not defined in ISO9000, by the way) and exclude (for example) your quality policy. I have no problem working with a list of things which an organisation needs to define, but it is up to the organisation to decide how to do it, where to record it and what to do with it. As Jane says, you can build all the elements separately into a corporate intranet. In most cases I see no need for a separate "manual" - not even the standard explains why it would be needed, although it (unfortunately) implies that it is.

 

[Big Jim]

Re: Quality Manual 9000:2008

Jim

To my mind there is no reason for the standard to pick the few things which it says should be included in a "manual" (a term not defined in ISO9000, by the way) and exclude (for example) your quality policy. I have no problem working with a list of things which an organisation needs to define, but it is up to the organisation to decide how to do it, where to record it and what to do with it. As Jane says, you can build all the elements separately into a corporate intranet. In most cases I see no need for a separate "manual" - not even the standard explains why it would be needed, although it (unfortunately) implies that it is.

It doesn't matter what you "feel". It is much more than an implication. There is a shall attached. It is a requirement.

Not every word in ISO 9001:2000/2008 is referenced in ISO 9000. That doesn't mean we can give such words any meaning we want. Common sense and common dictionaries dictate differently.

 

[JaneB]

Re: Quality Manual 9000:2008

To my mind there is no reason for the standard to pick the few things which it says should be included in a "manual" (a term not defined in ISO9000, by the way) and exclude (for example) your quality policy.

No reason? I disagree. I think there are very good reasons for each of the components it insists upon are included - I certainly don't see them as included on some arbitrary or 'what the hell?' basis (which a response of there being 'no reason' seems to say).

And re. quality manual, yes it is. See 3.7.4 in ISO 9000 for the definition of a quality manual as a "document specifying the quality management system of an organisation" (each term in italics references other definitions in it)

There is a shall attached. It is a requirement.

Yes, it is.

But nothing in ISO 9001 can or should be interpreted to read that there must be a separate document or that it be called a quality manual (or even that it meet the 'traditional structures and formats' that certain auditors may have become familiar with and accustomed to. It's just 'information and its supporting medium', and may be done in a whole variety of media and structures - to suit the needs and purpose of the organisation.

Any adequately intelligent and competent auditor I've every come across can cope with (say) an intranet or an online application or other alternative medium provided (of course) that it meets the requirements stated in ISO 9001 for documentation, including a 'quality manual'. Even when it isn't called that, and even when it isn't a document or something 'separate'.

Indeed, most of the best implementations of 9001 I've seen are when companies really embrace the principles of 9001 and embed them into their management system, including documents.

 

[Jim Wynne]

Re: Quality Manual 9000:2008

No reason? I disagree. I think there are very good reasons for each of the components it insists upon are included - I certainly don't see them as included on some arbitrary or 'what the hell?' basis (which a response of there being 'no reason' seems to say).

And re. quality manual, yes it is. See 3.7.4 in ISO 9000 for the definition of a quality manual as a "document specifying the quality management system of an organisation" (each term in italics references other definitions in it)



Yes, it is.

But nothing in ISO 9001 can or should be interpreted to read that there must be a separate document or that it be called a quality manual (or even that it meet the 'traditional structures and formats' that certain auditors may have become familiar with and accustomed to. It's just 'information and its supporting medium', and may be done in a whole variety of media and structures - to suit the needs and purpose of the organisation.

Any adequately intelligent and competent auditor I've every come across can cope with (say) an intranet or an online application or other alternative medium provided (of course) that it meets the requirements stated in ISO 9001 for documentation, including a 'quality manual'. Even when it isn't called that, and even when it isn't a document or something 'separate'.

Indeed, most of the best implementations of 9001 I've seen are when companies really embrace the principles of 9001 and embed them into their management system, including documents.

Amen. Quality people need to understand that contents and containers are different categories. We need to spend more time concerned about the former, and much less on the latter.

 

[Big Jim]

Re: Quality Manual 9000:2008

No reason? I disagree. I think there are very good reasons for each of the components it insists upon are included - I certainly don't see them as included on some arbitrary or 'what the hell?' basis (which a response of there being 'no reason' seems to say).

And re. quality manual, yes it is. See 3.7.4 in ISO 9000 for the definition of a quality manual as a "document specifying the quality management system of an organisation" (each term in italics references other definitions in it)



Yes, it is.

But nothing in ISO 9001 can or should be interpreted to read that there must be a separate document or that it be called a quality manual (or even that it meet the 'traditional structures and formats' that certain auditors may have become familiar with and accustomed to. It's just 'information and its supporting medium', and may be done in a whole variety of media and structures - to suit the needs and purpose of the organisation.

Any adequately intelligent and competent auditor I've every come across can cope with (say) an intranet or an online application or other alternative medium provided (of course) that it meets the requirements stated in ISO 9001 for documentation, including a 'quality manual'. Even when it isn't called that, and even when it isn't a document or something 'separate'.

Indeed, most of the best implementations of 9001 I've seen are when companies really embrace the principles of 9001 and embed them into their management system, including documents.

Nicely balanced response. However your assumptions about what he ment don't match what he has stated.

I have no trouble with unconventional quality manuals, at least to a point. I have seen them called a variety of things other than a "quality manual". Operations Manual, Company Guidance, Business Manual, and Management Directives are among some of the titles that come to mind. I do expect to see some reasonable structure, and I certainly expect to see the three specific things specified in a, b, and c of 4.2.2. A collection of documents scattered on the company hard drive with no organization certainly would not quality, nor would a file folder with a bunch of things thrown into it without any semblance of order.

 

[JaneB]

Re: Quality Manual 9000:2008

I do expect to see some reasonable structure, and I certainly expect to see the three specific things specified in a, b, and c of 4.2.2.

There's not an argument from me when something is a mandatory requirement of the Standard. So if you're just saying these 3 things must exist, then yes, I agree with you. (If however, you are also saying - or implying/assuming - they ought to exist in specific formats or structures, I don't.)

A collection of documents scattered on the company hard drive with no organization certainly would not quality, nor would a file folder with a bunch of things thrown into it without any semblance of order.

I think we're in agreement here Jim! It's pretty hard for someone to argue 'we've got a system' when there's no organisation or order to it which can be explained or demonstrated.

 

[Big Jim]

We are in agreement.

 

[Peter Fraser]

Re: Quality Manual 9000:2008

No reason? I disagree. I think there are very good reasons for each of the components it insists upon are included - I certainly don't see them as included on some arbitrary or 'what the hell?' basis (which a response of there being 'no reason' seems to say).

And re. quality manual, yes it is. See 3.7.4 in ISO 9000 for the definition of a quality manual as a "document specifying the quality management system of an organisation" (each term in italics references other definitions in it)



Yes, it is.

But nothing in ISO 9001 can or should be interpreted to read that there must be a separate document or that it be called a quality manual (or even that it meet the 'traditional structures and formats' that certain auditors may have become familiar with and accustomed to. It's just 'information and its supporting medium', and may be done in a whole variety of media and structures - to suit the needs and purpose of the organisation.

Any adequately intelligent and competent auditor I've every come across can cope with (say) an intranet or an online application or other alternative medium provided (of course) that it meets the requirements stated in ISO 9001 for documentation, including a 'quality manual'. Even when it isn't called that, and even when it isn't a document or something 'separate'.

Indeed, most of the best implementations of 9001 I've seen are when companies really embrace the principles of 9001 and embed them into their management system, including documents.

Jane Thanks - of course you are correct that "quality manual" is defined. But as you have explained very clearly, the "document" ("manual") does not have to be a single entity, which is the point I was trying to reinforce.

What I was also questioning (perhaps to encourage folk to interpret the requirement in the best way for their own situation) was the list of things to be included in "it", and why "it" is listed as a separate requirement - why not also include the policy, objectives, the name of the management rep...? (Or just say that all these things need to be defined - it was the "reason" for the specific list I was questioning)

 

[tmoreau]

Re: Quality Manual 9000:2008

The quality manual can be a SINGLE PAGE. There are quite a few examples of this, some companies use a tri-fold pamphlet as the quality manual. Mine is three pages, around 100 words. You will need to refer to you procedures of course.

On the other hand, there are many examples of 100+ page manuals. It really comes down to the needs and size of your organization. The QM is the top level document that introduces someone new to your system, and provides a map/overview/reference for the people who use your system daily. It can state your 'policy' on how things are done, where a 'procedure' for people to follow is not required. It can even include procudres if you choose.