Hi all,

I hope you all had a good weekend? I've just had a meeting with my boss who raised an interesting question. As ISO 9001:2000 is quite 'product' focussed, if we want to implement it to encompass the whole business to ensure control and quality of practice within - for parts that wouldn't necessarily effect product quality - is it the right standard?

It has taken me some time to get my head around what the QMSs roll is within the company. The roll of Quality Assurance Representative for me is a part time one, but an interesting one. One thing for sure is that I am no quality professional! My knowledge is quite limited. Within the Cove are a considerable number of seasoned vets when it comes to quality and its management. Can you help?

All comments gratefully accepted.

Regards

Anthony

Hi all,

I hope you all had a good weekend? I've just had a meeting with my boss who raised an interesting question. As ISO 9001:2000 is quite 'product' focussed, if we want to implement it to encompass the whole business to ensure control and quality of practice within - for parts that wouldn't necessarily effect product quality - is it the right standard?

It has taken me some time to get my head around what the QMSs roll is within the company. The roll of Quality Assurance Representative for me is a part time one, but an interesting one. One thing for sure is that I am no quality professional! My knowledge is quite limited. Within the Cove are a considerable number of seasoned vets when it comes to quality and its management. Can you help?

All comments gratefully accepted.

Regards

Anthony

Hi, Anthony!

At the risk of sounding like a smart Aleck, let me ask:

If a part won't effect product quality, why are you making it in the first place? The answer will either be "we shouldn't be making it" or "well, it actually does effect quality".

ISO 9001:2000 can be applied to all types of organizations, be it manufacturing, service, government, non profit...

Quality Assurance is a big topic, and, in my case anyway, previous "knowledge" led me to keep thinking about inspection-based quality approaches. As you appear to be finding out, its a LOT bigger than that.

If you can give us some more specific information, maybe we can be more help?

Anthony:

You have raised a question that has been the cause of some debate in the Cove over the years. There are many of us that apply the requirements of ISO 9001 beyond the mere "shalls" and the key product.

Afterall, why have multiple systems in one organization? Why should key product be treated differently than that which is deemed non-key? Does not the concept of a Business Management System appear more sound and in line with good practice?

Can it cost more money? Technically yes. You are controlling the processes for everything that you do. But the intangible returns of having an effective management system which knows no boundaries can far outweigh those accounting notes. One system...one language...one culture.

At the end of the day, however, it is your organization's system. You get to decide how to structure the management system. You may be ISO registered to those key products and conform to the requirements with the rest. It's up to you to determine the scope of your audits and application of the requirements. There is really no limit to how you wish to expand the requirements of ISO 9001.

But do it only if it is right for your organization.

Hi all,

I hope you all had a good weekend? I've just had a meeting with my boss who raised an interesting question. As ISO 9001:2000 is quite 'product' focussed, if we want to implement it to encompass the whole business to ensure control and quality of practice within - for parts that wouldn't necessarily effect product quality - is it the right standard?

It has taken me some time to get my head around what the QMSs roll is within the company. The roll of Quality Assurance Representative for me is a part time one, but an interesting one. One thing for sure is that I am no quality professional! My knowledge is quite limited. Within the Cove are a considerable number of seasoned vets when it comes to quality and its management. Can you help?

All comments gratefully accepted.

Regards

Anthony

Anthony,

What exactly does your company "do" ?

In part 3 of the standard (ISO 9k), it mentions that where the word PRODUCT appears, it may also mean SERVICE. Therefore, the standard can be applied to any sort of business ... be it manufacturing, service, consulting, etc...

Let us know more about what your company does and I´m sure we can help you more...

Anthony,

What exactly does your company "do" ?

In part 3 of the standard (ISO 9k), it mentions that where the word PRODUCT appears, it may also mean SERVICE. Therefore, the standard can be applied to any sort of business ... be it manufacturing, service, consulting, etc...

Let us know more about what your company does and I´m sure we can help you more...

Ted,

According Anthony's public profile, his company is in the Medical Devices - Orthopaedic Training business.
There is also a link to Anthony's company. Very interesting.

Stijloor.

Working in a service (sales) organization, I can vouch for the fact that having properly defined (and documented) processes would save a whole lot of staff grief, losses, time and, therefore, money. Even though we don't have a 'product', in the conventional sense, I can vouch for the fact that my organization wastes significant amounts of time learning how to do things we don't do on a daily basis, for example. Then there's the constant to-ing and fro-ing between people when paperwork's not correct etc.

I'm not sure why you or your boss thinks that ISO 9000 is 'product centric' because the writers have tried to reduce that and make it applicable across an organization.

Hi, Anthony!

At the risk of sounding like a smart Aleck, let me ask:

If a part won't effect product quality, why are you making it in the first place? The answer will either be "we shouldn't be making it" or "well, it actually does effect quality".

If you can give us some more specific information, maybe we can be more help?
Hi Craig,

Forgive my lack of clarity in my original post. When I used 'part' I meant it to imply part of the business, rather than a part. We have had some free advice via a government run scheme. When they came round I had originally produced procedures for Accounts (as well as other parts of the business). I was informed that this wasn't necessary as Accounts' roll within the company did not have a direct effect on quality. The problem surely lies with my implementation of the ethos of 9k and where it stands for us. If you read pt 1 Scope 1.1 General it states that the Standard specifies requirements for a QMS where an organization

a) needs to demonstrate its ability to consistently provide product (or service etc) that meets customer and applicable 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 regulatory requirements.

This I think is why it feels more production oriented for my boss. I guess my boss wants to see the implementation on a grander scale than I maybe originally looked at. Or else I just need to reword stuff!?

Anthony

Anthony:

You have raised a question that has been the cause of some debate in the Cove over the years. There are many of us that apply the requirements of ISO 9001 beyond the mere "shalls" and the key product.

Afterall, why have multiple systems in one organization? Why should key product be treated differently than that which is deemed non-key? Does not the concept of a Business Management System appear more sound and in line with good practice?

Can it cost more money? Technically yes. You are controlling the processes for everything that you do. But the intangible returns of having an effective management system which knows no boundaries can far outweigh those accounting notes. One system...one language...one culture.

At the end of the day, however, it is your organization's system. You get to decide how to structure the management system. You may be ISO registered to those key products and conform to the requirements with the rest. It's up to you to determine the scope of your audits and application of the requirements. There is really no limit to how you wish to expand the requirements of ISO 9001.

But do it only if it is right for your organization.
I guess it is a matter of looking at the system as a business management tool rather than just a quality management tool. Yes there is more cost involved, but as you said the effects on the business as a whole will be beneficial and probably cost effective in the long run.

Thanks

Anthony

It's not product focused, it's "Customer Satisfaction and Improvement" focused, just get away from the 4.1-8.5.3 stuff and read the front of the Standard. I know of a church that has used ISO 9001 to improve its internal operations.

Refer this thread - What types of organizations are registered to ISO 9001? (http://elsmar.com/Forums/showthread.php?t=20614)

Hello, Anthony!

In short, yes I feel it is the right thing for you. Now, there are many components to this machine. There is the standard, there is (most important) management and their perspective, a consultant (if you choose one; may not be a bad idea), and to an extent, the auditor(s). Saying, the pendulum could swing quite a ways on what kind of system you have.

You utilize the standard to develop a system that works for you, your application, your people, etc. Now, to your manager- It will do little good to have one perception, while the boss has another. Management is key with an effective quality system. Your manager needs to believe that the QMS will help him/her. If they are confused/ reticent, it will involve some time communicating and clarifying what those goals are. When your management has identified those goals, you develop the QMS to achieve those goals.

Hope something here helps.

Anthony,

Maybe an Accounts procedure isn't needed for a QMS (and we have discussed this very topic at length here at the Cove), certainly most organizations would be better off with a good procedure for Accounts than they would be without one. (Invoicing errors can impact a customer's view of the quality of a company, for instance). But, as has been mentioned it is your system, and you get to decide the scope. As Roxane so wisely pointed out, why do things one way for a part of the organization, and have another approach for other portions?

Anthony,

Why is your company interested in ISO 9001?

Who in your company wants to pursue ISO 9001?

Do you have support from top management?

Are there any who might be opposed to an ISO 9001 implementation?

How far along are you?

One of our frequent Cove posters (credit to Helmut Jilling) has a great sig line. Since he hasn't jumped into this thread, and because I believe it reflects an important and often overlooked concept, I'm going to take the liberty of paraphrasing it here:

If it isn't saving us time or money, why are we doing it?

Anthony,

Why is your company interested in ISO 9001?

To show our customers that we are committed to giving them the best possible solutions we can, repeatedly

Who in your company wants to pursue ISO 9001?

Upper management

Do you have support from top management?

Yes, but not full understanding - but we're getting there!

Are there any who might be opposed to an ISO 9001 implementation?

A few I suppose, but only because of a fear of change

How far along are you?

Pre-audit booked for the beginning of February!

One of our frequent Cove posters (credit to Helmut Jilling) has a great sig line. Since he hasn't jumped into this thread, and because I believe it reflects an important and often overlooked concept, I'm going to take the liberty of paraphrasing it here:

I like that quote. It takes me back to the Lean workshops that we did a couple of years ago. Very apt for our company as we stand and after the meeting I just had. I shall have to dig my old Lean toolbox out very soon.

'to increase sales' would be my answer to that wonderful question......

'to increase sales' would be my answer to that wonderful question......

:rolleyes: Ultimately yes :D

Anthony,

No red flags in any of your answers, though educating your top management would be a good idea. If I were in your place, I would push to get this done before the pre-assessment. Your management team needs a good framework for evaluating whatever the auditors tell them.

To answer your original question - if you've done the process work required by ISO 9001, then it should be possible to show how it touches the different parts of the organization.

If some parts of the organization appear to be left out (leaving the debate about accounting aside for a moment) maybe you need a bit more process work.

I suggest you set aside 9001 for a while

Study ISO 9004 first to get a better understanding of the application of key "quality" concepts to business

Also why not google the National Business - Excellence Models

Baldridge
NQI Canada
EFQM

Tom Peters is still In Search of Excellence, much goodness there

My favorite business book is "Ricardo Semler - Maverick" so radical it is beyond belief. I lent my copy to my boss and he burned it.

"lean" works wonders outside of manufacturing

Deming was all about improving management

ISO 9001 is small q quality focused

I talk in terms of Big Q - which means to me application of the quality tool kit to business....any business, even service.

Some food for thought