How important is a Quality Manual - ISO 9001:2008 to 9001:2015

[matti]

Hi.
ISO 2015 version do not require a quality manual but our company insist to have one in place as this is a good reference point to what is required of a System the ensure the product meet he customer requirements.
The higher structure of the current manual is not inline with the new High Level Structure.

1. How important or essential is to ensure that the the quality manual if still to be kept represent the higher Structure of the 9001:2015?

(It is a quite difficult task and it is a puzzles of throwing this up in the air and trying to put the pieces together.)

We have a three years grace to adapt to the new standards . I am currently reviewing the entire document and need to know if there is a template manual that I can follow.. Quality Gurus has some tool to aid you but this is breaking my brain cells to update the table than the content accordingly.

I am not in a hurry but would like to get it right first time.

Cheers for any aid that I can get. :

 

[Jen Kirley]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Hi Matti,

While the language between the two standards differs quite a lot, if we look at our operations closely we might find there is relatively little that we are not already doing.

That means your manual might not need to change much, indeed if you will still have one because customers want it or because you decide you want it.

I would not lose any sleep about this right now. There is plenty of time and I have no doubt there will soon enough be examples to find on the web.

The key difference would be in identifying stakeholders and their needs, then drawing connections between that and the products and services you already provide. Then, using that list to decide what is relevant, maybe something so simple as a SWOT analysis - or maybe different SWOTs for different processes, products/services - can help you decide on what to point to for operational controls (risk based thinking). You will probably find your own existing procedures are adequate but there will be some additional considerations like involving employees.

I hope this helps!

 

[matti]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Thank you.
I will take all of this into consideration.

 

[dsheaffe]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Hi Matti,

I agree with Jennifer, don't stress about it yet - and yes there are likely to be plenty of template/example "quality manuals" posted on line in due course - probably most of which will be a re-write of the standard - and personally, none I would ever use.

As to your question - no if you retain a quality manual it does not need to aligned to the structure of the standard (and never did - but it was an easy approach for many organisations).

My suggestion would be, this is a perfect opportunity to take a long hard look at your quality manual and decide what actually needs to be included. eg, your manual could just include your quality policy, a high level process flow of your business, information about stakeholders, scope of your QMS, etc

Good luck.

 

[Big Jim]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Perhaps I can add to the already great comments.

When the transition between ISO 9001:1994 and ISO 9001:2000 was underway, a few companies retained their old manual. As time went on, trying to juggle between a manual that was oriented to the numbering system of the 1994 version with the new standard generally proved to be confusing. If past is prolog that is what will happen again.

Although a manual is not required by the new standard, those who wrote the standard, according to their chairman, anticipate that most companies will still want one.

As a consultant who has written many of them, I don't see the demand for them dropping off. Every client that I have told that a manual will no longer be required was dumbstruck, asking how could a company's quality management system survive without one.

Sit down with the new standard, the correlation matrices, and your existing manual and figure out what changes you need to make.

 

[RLGALLAGHER]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Does anyone have a spreadsheet/matrix which might outline the new element along with intent....aligned with the revised 2008 standard.....sort of a gap analysis (or even a cross-reference/index:

 

[Jen Kirley]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Does anyone have a spreadsheet/matrix which might outline the new element along with intent....aligned with the revised 2008 standard.....sort of a gap analysis (or even a cross-reference/index:

There's a correlation matrix here, but intent is too soon to look for among the ISO 9001 Auditing Practices Group list of guidance documents. I will be paying attention to this web page for updates to these linked documents for insights the standard may lack.

 

[AndyN]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Hi.
ISO 2015 version do not require a quality manual but our company insist to have one in place as this is a good reference point to what is required of a System the ensure the product meet he customer requirements.
The higher structure of the current manual is not inline with the new High Level Structure.

1. How important or essential is to ensure that the the quality manual if still to be kept represent the higher Structure of the 9001:2015?

(It is a quite difficult task and it is a puzzles of throwing this up in the air and trying to put the pieces together.)

We have a three years grace to adapt to the new standards . I am currently reviewing the entire document and need to know if there is a template manual that I can follow.. Quality Gurus has some tool to aid you but this is breaking my brain cells to update the table than the content accordingly.

I am not in a hurry but would like to get it right first time.

Cheers for any aid that I can get. :

Not at all. In fact, having a manual which emulates the standard isn't much use to the user, in actual fact. Ditch the idea that you have to show a clause by clause alignment. Find a model of a manual which people actually understand, use, can read etc and when the changes come, adopt that. Unless you have an anal retentive customer who wants the old fashioned manual - but then do you want your customer telling you how to run your QMS?

 

[Big Jim]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

Not at all. In fact, having a manual which emulates the standard isn't much use to the user, in actual fact. Ditch the idea that you have to show a clause by clause alignment. Find a model of a manual which people actually understand, use, can read etc and when the changes come, adopt that. Unless you have an anal retentive customer who wants the old fashioned manual - but then do you want your customer telling you how to run your QMS?

There is no reason that a quality manual can't do both. The ones I write do. If they do, it would be less confusing if they are aligned to the most current standard.

 

[AndyN]

Re: ISO 9001:2008 to 9001:2015 Quality Manual

There is no reason that a quality manual can't do both. The ones I wright do. If they do, it would be less confusing if they are aligned to the most current standard.

For whom? It's not a case of "less confusing". There should be NO confusion. That's why I said, ditch the conventional wisdom of a clause by clause manual. Don't forget when you "wright" a manual, your clients don't know any better - they accept you are giving them something which is required (when many know it isn't) and will smile and pay you...

The fact is, a manual isn't going to be required, so why continue to keep one foot in the 20th century?