Can a company pick which areas of the operation they wish to claim ISO compliance?

I understand 9001/9002/9003 differences, but can it be broken down even further....

.... say we just want to "claim" ISO compliance in our manufacturing operation, or just in our warehousing?

I don't believe it is possible, but my boss does. :whip:

I'm looking for the right answer to give him. :read:

Thanks.

The short answer is no. It's a system standard, and should be implemented in your system - not just one process. Having said that, I've seen companies claim "compliance" to just about anything. Without lying though, you can't really claim compliance without implementing in your whole system.

First - There is only one standard ISO 9001:2000 - the 9001/2/3 designation was eliminated upon release of the 2000 edition.

Second - if you are only going to be compliant you can probably do whatever you want (re: no "independent" party to verify). Having said that, with the new version (2000) it very difficult to separate functions as it is "process" driven and not product driven standard now.

There is some flexibility in what would apply to your operations, however, this only applies to Section 7 of the standard AND you must be able to prove this if you were to have a registrar review your system.

Recommendation - Buy the standard and read it. If necessary, get updated training on the 2000 edition as it changed dramatically from the 1994 version. In addition, do a search of the Cove for this information; there are plenty of threads about the standard.

John

1st there is no 9002 or 9003 anymore, they were done away with about 7 years ago.

As for picking and choosing... ISO 9001:2000 allows exclusionary claims only in Section 7 "Product Realization", but the claims have to be clearly documented and supported in the Quality Manual as specified in clause
1.2 Application
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),

Can a company pick which areas of the operation they wish to claim ISO compliance?

I understand 9001/9002/9003 differences, but can it be broken down even further....

.... say we just want to "claim" ISO compliance in our manufacturing operation, or just in our warehousing?

I don't believe it is possible, but my boss does. :whip:

I'm looking for the right answer to give him. :read:

Thanks.

Yes, you can claim compliance for a part of the company.
It's even possible to get certified for a part of the company or a range of products you manufacture.

By the way : Since 2000 the standards 9002 and 9003 do no longer exist.
The only existing standard ( in that range ) is ISO 9001.

Best regards,

Antoine

It seems your answer is different than those preceding.

Please explain how "It's even possible to get certified for a part of the company or a range of products you manufacture."

This is where I'm getting mixed up. :bonk:

It seems your answer is different than those preceding.

Please explain how "It's even possible to get certified for a part of the company or a range of products you manufacture."

This is where I'm getting mixed up. :bonk:

I was talking about areas of operations ( like in your post )
Not about areas of ISO 9001 ( as in your post title )

Best regards,

Antoine

It seems your answer is different than those preceding.

Please explain how "It's even possible to get certified for a part of the company or a range of products you manufacture."

This is where I'm getting mixed up. :bonk:

Sorry, I had amended the title of this thread to be in line with your post.

While I had not seen it been done for manufacturing related organizations, there are many in the service industry who are certified to certain scopes such as 'provision of credit card service' for some banks, etc. We also had a recent user talking about certification for 'provision of support service' or something like that for health-care industry.

Can a company pick which areas of the operation they wish to claim ISO compliance?

I understand 9001/9002/9003 differences, but can it be broken down even further....

.... say we just want to "claim" ISO compliance in our manufacturing operation, or just in our warehousing?

I don't believe it is possible, but my boss does. :whip:

I'm looking for the right answer to give him. :read:

Thanks.

Yes, and no. Can I ask why your boss is suggesting such a thing? You can get registered as Antoine says - registrars don't always 'see' the other parts of the business (they might not know about the warehouse down the road without a sign on it)

But, as has been pointed out, it's a system of processes which affect the product you deliver to the customer for their satisfaction and your profitability. In which case, why would anyone want to leave something 'out'?

QUESTION: WHY?
ANSWER: As with most things.... least amount of effort (and cash) for the biggest return (ISO claim).

I am not in agreement with this. We are a medical device manufacturer and we ARE in FDA compliance. The ISO thing is the most recent "flavor of the month".

Everything I've researched, and the consensus of Cove answers, tell me that you are either ISO registered, or you are not. That's what I'll relay.

Thanks. :thanx:

Everything I've researched, and the consensus of Cove answers, tell me that you are either ISO registered, or you are not. But your original question wasn't about registration; it was about compliance. You can be compliant without being registered, but you can't (at least in theory :cool:) be registered without being compliant. If your boss wants to claim compliance for only the cleaning and operation of the restrooms, he can do that, just as he can tell any other lie if he wants to. It would be a bad idea, because knowledgeable outsiders will immediately know that smoke is being blown.

But your original question wasn't about registration; it was about compliance. You can be compliant without being registered, but you can't (at least in theory :cool:) be registered without being compliant. If your boss wants to claim compliance for only the cleaning and operation of the restrooms, he can do that, just as he can tell any other lie if he wants to. It would be a bad idea, because knowledgeable outsiders will immediately know that smoke is being blown.

EXACTLY! If we tell customers (hospitals, doctors, governmental agencies) that we are ISO Compliant.... they will expect that we are registered and I would expect them to ask for documentation.

The intent of the original question was to include "registration".

Yes. As has been already said, it is very much possible to get parts of your organisation certified.

I shall give an example. An automobile manufacturer has its car division, SUV division and truck division (product lines) all separately certified. Again, the parts procurement division and the servicing stations division (operational areas) are separately certified.

All of these have properly defined and maintained QMS with the Policy, the Objectives, the customer, his requirements, the suppliers, controls on them ... all clearly defined and maintained.

If one were to consider the whole behemoth included and certified under a single QMS, it would be an unwieldy project to say the least.

Again, whom do you consider the customer? The distributor or the end user?

Now you can review your case in light of what I have portrayed above. You will be the best person to decide whether breaking up your system makes sense at all, and then in what fashion. What exactly does your boss want and why.

The decision is yours.

EXACTLY! If we tell customers (hospitals, doctors, governmental agencies) that we are ISO Compliant.... they will expect that we are registered and I would expect them to ask for documentation.

The intent of the original question was to include "registration".

If you claim to be registered but you aren't, I think that a case for fraud could be made, depending on the circumstances. Claiming compliance, in other words, is a your-word-against-theirs sort of thing because there are no objective criteria that are universally accepted.

Yes. As has been already said, it is very much possible to get parts of your organisation certified.

I shall give an example. An automobile manufacturer has its car division, SUV division and truck division (product lines) all separately certified. Again, the parts procurement division and the servicing stations division (operational areas) are separately certified.

Now you can review your case in light of what I have portrayed above. You will be the best person to decide whether breaking up your system makes sense at all, and then in what fashion. What exactly does your boss want and why.

The decision is yours.

With respect, this isn't the same as 'leaving out' manufacturing and only having the warehouse be in compliance and registered.

In your example, (with which I am intimately familiar), parts of the organization do, in fact, slip through the compliance net. Furthermore, car makers tend to be very complex and large organizations, so it's difficult to have one quality management system. What's more, how would any external auditor actually grasp the enormity and inter-relationship of a major car producer like, let's say, Ford?

What about some of the organizations you didn't mention.........?

I rather doubt that the OP has a qms for a warehouse, separate from the manufacturing organization, one for HR etc.

You could get registered but that not really in complianceto do such a thing.

If you claim to be registered but you aren't, I think that a case for fraud could be made, depending on the circumstances. Claiming compliance, in other words, is a your-word-against-theirs sort of thing because there are no objective criteria that are universally accepted.

And also, couldn't your customers require that your company become registered once you let them know that you are "compliant"? I mean, from the customer's point of view, if a company is "compliant", why wouldn't they want to go all the way and become registered? :caution: Could create some problems in the future....

I rather doubt that the OP has a qms for a warehouse, separate from the manufacturing organization, one for HR etc.

You could get registered but that not really in complianceto do such a thing.

I don't know sufficient details about the OP's organisation. Thats why I have offered him a case where such a breakup as he is discussing can and is done because it needs to be done. I again specifically highlight the fact that each of these pieces has a complete QMS of its own.

Now it is left to the OP to review his status and decide whether he needs to and can breakup his operations for the sake of certification - then again in what fashion.

Yes. As has been already said, it is very much possible to get parts of your organisation certified.

I shall give an example. An automobile manufacturer has its car division, SUV division and truck division (product lines) all separately certified. Again, the parts procurement division and the servicing stations division (operational areas) are separately certified.

All of these have properly defined and maintained QMS with the Policy, the Objectives, the customer, his requirements, the suppliers, controls on them ... all clearly defined and maintained.

If one were to consider the whole behemoth included and certified under a single QMS, it would be an unwieldy project to say the least.

Again, whom do you consider the customer? The distributor or the end user?

Now you can review your case in light of what I have portrayed above. You will be the best person to decide whether breaking up your system makes sense at all, and then in what fashion. What exactly does your boss want and why.

The decision is yours.
I am not going to get involved in what will surely turn into a circular argument. ;)

...... But having said that I can't resist making my feelings known. :lol:

ISO 9001 is a simple document. It is, however, based on some very strong principles including the systems approach. In a nutshell this says: "if you add up the sum of the parts the whole gives you more."

So if you try and deconstruct an organization into component divisions, departments, work teams you have missed a major reason for the standard being out there. :bonk:

Same with the process approach that I have ranted about on these and other threads until I am blue in the face. If you stop your process at department boundaries you have missed the point and the opportunity the process approach gives you.

I'll now take a step back. There may be very good justified reasons why an organization might pilot one area and then, over a period of time, roll out a certification programme to other areas of the business, picking up on interface issues as they go.

There are many consultants, CBs and auditors out there who can find a justification for pocket sized systems and certification.

I can't. :2cents:

Paul,

Absolutely right! I have gained some very thick skin trying to explain to the "old guard" that processes don't stop at departmental boundaries.

I was lucky enough to work for someone that completely understood the process approach. Unfortunately, that is in the past tense. I am now stuck still getting the higher ups to understand the complete process approach (re: what happens in design DOES affect the integrity of the packaging of the product).:truce:

Again - thanks for verifying that there is at least one other person out there that understands it.

John

I am not going to get involved in what will surely turn into a circular argument. ;)

...... But having said that I can't resist making my feelings known. :lol:

Whoa ! No circular arguments definitely:truce:

I'll now take a step back. There may be very good justified reasons why an organization might pilot one area and then, over a period of time, roll out a certification programme to other areas of the business, picking up on interface issues as they go.

There are many consultants, CBs and auditors out there who can find a justification for pocket sized systems and certification.

I can't. :2cents:

We are entitled to our :2cents: about what is justified and what is pocket sized. What really matters is the OP's :2cents: - and maybe, more so, his boss's :2cents:;)