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  Permissible Exclusions

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Author Topic:   Permissible Exclusions
Marc Smith
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Posts: 4119
From:West Chester, OH, USA
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posted 17 August 2000 10:31 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:12:01 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Arbuckle/Salinger

From: rudy.salinger@dowcorning.com

Although ISO 9001:2000 would say "purchasing" cannot be excluded from the Quality System scope, it should be possible to address this requirement with minimal effort. The process which you would have to "establish, document, implement, and maintain" might be as simple as a statement in the top level documentation (Quality Manual) that "no materials or services that affect product quality are purchased. All other purchases are at the discretion of the employee requiring them." But you will have to be sure the exclusion of "services" as well as materials is valid, otherwise you will indeed have to put up a process.

The justification for this approach is the statement in ISO 9001:2000 that "The type and extent of control shall be dependent upon the effect on subsequent realization processes and their output."

This is my opinion, but it should be verified with the firm's registrar.

Rudy Salinger

> From: "Donald Arbuckle"
> Let me see if I understand this...

> If my company does not purchase anything (all parts, equipment, facilities,
> etc. are provided by the customer) other than laser paper for office use,
> pens/pencils, etc, then in order to meet the requirements of the standard
> and become compliant/registered, I must still establish, document, implement
> and maintain a purchasing process? Doesn't this conflict with the
> requirements in 4.1 a), "identify the processes needed for the quality
> management system"?
> [I have other examples, but all reflect the same point...]

> I look forward to the technical specification that makes this perfectly clear...

>> From: "Trudeau, Pat"
>> John:
>> I have talked to a TAG team member personally about this and the only
>> exclusions are servicing and design. The team is in process of writing a technical
>> specification on the permissible exclusions right now that will make everything
>> crystal clear. You can also call ASQ directly and talk to Patty Kopp in standards
>> who will verify this.

**************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:13:45 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Hartman

From: dhartman@phdinc.com

Pat Trudeau stated, "I have talked to a TAG team member personally about this and the only exclusions are servicing and design."

In fact at this year's ASQ Annual Quality Congress Charles Cianfrani stated that the reason that 7.6 Control of Measuring and Monitoring Devices was placed in Section 7 was to allow service organizations the ability to take exception to it (since Section 7 is the only section where exceptions can be taken).

This would lead me to believe that it was "intended" (at least by some members of the TAG) to allow for exceptions to be taken to any/all portions of Section 7.0, as appropriate for your organization.

David Hartman

***************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:28:58 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Kozenko

From: Write9000@aol.com

Don Arbuckle writes:
> If my company does not purchase anything (all parts, equipment, facilities,
> etc. are provided by the customer) other than laser paper for office use,
> pens/pencils, etc, then in order to meet the requirements of the standard
> and become compliant/registered, I must still establish, document, implement
> and maintain a purchasing process? Doesn't this conflict with the
> requirements in 4.1 a), "identify the processes needed for the quality
> management system"?

Don and List:

I'm not saying "do this or else" because it's not appropriate for every firm, but here's a case where the answer to your inquiry is "Yep, you need Purchasing Procedures in all cases..."

I stayed late one evening (when my kids were young, no less ;o) to manually "baby-sit" the high-speed copy machine while we (as in, me and the machine ;o) ran 20 copies of a report due to the client, earlier that morning.

INDIRECTLY, the purchase of a bargain brand of copier paper had resulted in a mechanical incompatibility. Or in other words, the cheap paper didn't work worth a squat in the high speed copier.

The administrator who bought the paper thought he was doing great things because he saved the company a boatload of money. He wasn't reprimanded too much, because his intentions were sincere and there were no written procedures for purchasing. (Sincerity didn't matter, but the lack of Procedures did.)

Now, some firms can quickly attack the "Direct" impact on quality factors and stop there, and everything is fine. For those firms (and per your Post question), no Purchasing procedure would be required.

There might be other firms where a similar "quality attack" needs to happen on "Indirect" and perhaps even "Consequential" impacts on quality (especially Human Resources decisions and policies) because the more visionary your quality thinking becomes, the more apt you are to include these latter two in the root cause analysis of today's quality problems and in the justification for Preventive Actions against tomorrow's.

David M. Kozenko

****************************

From: ISO Standards Discussion
Date: Thu, 10 Aug 2000 11:31:23 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Miller

From: Ray.Miller@dol.net (Ray)

All modern quality systems require procedures for documentation, training, purchasing, and contract review. If your employment agency or creative trade genuinely purchases no supplies or any materials, your H.R. process is therefor your purchasing process. If you contract your labor, your contract review procedures are your purchasing procedures.

The concept of a viable enterprise without a purchasing system is perhaps attractive, but will never actually work in the real world. The money leaves somewhere, somehow, and somebody gets it. Where does it go? How much? How often? With purchasing controls, you can answer all these questions.

--Ray

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Marc Smith
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posted 17 August 2000 10:37 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:30 -0500
Subject: Re: Permissible Exclusions /../Salinger/Arbuckle

From: "Donald Arbuckle" iso9kda@doitnow.com

Perhaps in my attempt to be clever (and somewhat facetious) my point got missed. I'll be more direct.

I cannot believe that the writers of the standard are truly saying that only Design and Servicing are permissible exclusions. If so, then why not say that, rather than leaving permissible exclusions open all of section 7. Mr. Hartman's post seems to support the idea that any part of section 7 can be excluded. That also appears to be the meaning of the statement in 1.2 Permissible Exclusions that reads, "These exclusions are limited to those requirements within clause 7..." I am in great disbelief that they meant anything other than what they said.

That said, if we "address" a requirement by stating in the Quality Manual that we do not do that work, isn't that the same as saying it under "permissible exclusions"? If not, what's the difference? If so, what's the beef?

Bottom line ... I have no question about the meaning of the Permissible Exclusions clause. It says that if a requirement in clause 7 is not applicable and does not affect the organization's ability to provide conforming product, then it does not have to be addressed further. It is excluded from the QMS.

Oh, by the way, I do have clients who have been successfully registered who do not do purchasing, others that do no packaging, others that do no inspections, and the list goes on. Each one has been registered without incident or question because of the nature of the organization's product, and/or customer requirements and/or applicable regulatory requirements. For real!

This should start a lively discussion...

Donald A. Arbuckle

*************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:39:08 -0500
Subject: Re: Permissible Exclusions /../Trudeau/Robinson

From: Ralph Robinson
>
> Pat Trudeau stated, "I have talked to a TAG team member personally
> about this and the only exclusions are servicing and design."
>

A recent discussion with our Manager, Regulatory and Quality Systems, and her subsequent enquiry of our ISO registrar has yielded quite a different scenario.

According to our Registrar, _all_ of Section 7 of ISO 9001:2000 is
subject to exclusion if your organization can show that those elements
do not exist. Based on this information I'd say that the following could
potentially be excluded in a ISO 9001:2000 registration:
1. Customer-Related Processes (highly unlikely as everyone has
customers)
2. Design and Development (definitely possible)
3. Purchasing (highly unlikely, but possible)
4. Production and Service Operations (VERY doubtful for production
operations, but possible for service operations)
5. Control of Measuring and Monitoring Devices (same as #4)

If you look at the possibilities realistically, then the person Pat Trudeau talked to might be, in fact, correct, even though the possibility to exclude something might actually exist.

I think one of the key elements that we all need before we can make educated assessments of how this new standard will impact our organizations is the final Transition Guideline document. Hopefully that will answer some of our questions. Failing that, I hope that ISO 9004:2000 provides some clarity.

Ralph E. Robinson

> From: rudy.salinger@dowcorning.com
> Although ISO 9001:2000 would say "purchasing" cannot be excluded from the
> Quality System scope, it should be possible to address this requirement with
> minimal effort. The process which you would have to "establish, document,
> implement, and maintain" might be as simple as a statement in the top level
> documentation (Quality Manual) that "no materials or services that affect
> product quality are purchased. All other purchases are at the discretion of
> the employee requiring them." But you will have to be sure the exclusion of
> "services" as well as materials is valid, otherwise you will indeed have to
> put up a process.
> The justification for this approach is the statement in ISO 9001:2000 that
> "The type and extent of control shall be dependent upon the effect on
> subsequent realization processes and their output."
> This is my opinion, but it should be verified with the firm's registrar.
>

****************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:47 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Kozenko/Hankwitz

From: "Hankwitz, John" John.Hankwitz@qtiworld.com

David M. Kozenko makes a good point. But beware of over doing things. Does a procedure REALLY need to be written as a result of this incident? I would think normal day-to-day feedback would be adequate.

I heard that one company actually wrote procedures for making coffee, and posted them by each coffee maker. The logic was that visiting customers were provided coffee on occasion, and they wanted to make sure they wouldn't get a nonconforming mouthful. Good Grief!

Most often, a basic "New Employee Training" program will take care of most of these petty situations. Reserve procedure writing for those things that can't be effectively handled through training.

John Hankwitz

> David M. Kozenko writes:
> I'm not saying "do this or else" because it's not appropriate
> for every firm, but here's a case where the answer to your
> inquiry is "Yep, you need Purchasing Procedures in all cases..."
>
> I stayed late one evening (when my kids were young, no less
> ;o) to manually "baby-sit" the high-speed copy machine
> while we (as in, me and the machine ;o) ran 20 copies of a
> report due to the client, earlier that morning.
> (snip)

****************************

From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:34:23 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Schoffman

From: ASchoffm@aol.com

<< From: "Donald Arbuckle"
Let me see if I understand this... If my company does not purchase anything (all parts, equipment, facilities, etc. are provided by the customer) other than laser paper for office use, pens/pencils, etc, then in order to meet the requirements of the standard and become compliant/registered, I must still establish, document, implement and maintain a purchasing process? Doesn't this conflict with the requirements in 4.1 a), "identify the processes needed for the quality management system"? >>

Don, I believe you have hit on the weakness of the Permissible Exclusions clause. I believe the real intent was to differentiate 9001:2000 from the 9002:1994 standard which permitted companies with design systems that affect quality to obtain certification to an ISO standard (9002) without including their design function.

As in the past, where a clause does not apply to a particular organization, they can exclude it by simply stating that it does not apply to them. The registration auditor determines whether this is valid. This is especially true in service organizations where calibration of test equipment, packaging and delivery, servicing, etc. will not apply.

It seems to me, therefore, that there should have been no permissible exclusion clause at all - just the general rule that if a functions affects the quality process, it must be included in the quality system. If not, as in your example, a simple statement to that effect would be sufficient.

Alan Schoffman

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Marc Smith
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From:West Chester, OH, USA
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posted 22 November 2000 05:46 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO 9000 Standards Discussion
Date: Tue, 31 Oct 2000 11:01:58 -0600
Subject: Re: Q: Permissible Exclusions ISO9000:2000 /Reid/Monnich/Trudeau

From: "Trudeau, Pat"

According to ISO/TC 176/SC 2/N 485 (if this version dated 26 April 2000 is still current) Section 3.3 Permissable Exclusions paragraph 3 states "The fact that a specific activity (such as Design and Development, or Purchasing) is outsourced, or carried out by a different entity, is not in itself adequate justification for the exclusion of that activity from the QMS. Overall responsibility for and/or coordination of that activity, may remain with the organization."

PAT

**************************************

From: ISO 9000 Standards Discussion
Date: Tue, 31 Oct 2000 11:06:31 -0600
Subject: Re: Q: Permissible Exclusions ISO9000:2000 /../Scalies/Deibler

From: Bill Deibler

If development groups are required to be a part of registration, a significant number of companies will refuse to comply.

For example, many high-tech company ISO registrations are for ISO 9002:1994. These companies have been resistant to pursuing ISO 9001, and have opted for other models for quality to support their engineering practices (for example, software engineering and the CMM).

There is a MUCH greater commitment when a company applies design control in an engineering department. This is quite demanding Charley. I have been doing ISO implementations in a variety of industries since 1989, and I have found 9001 in software and systems providers to be the most challenging. 9000 has always made sense to manufacturing folks, but has required a lot of interpretation in other disciplines (software and 9000-3 for example).

I think this can of worms is a huge one. I can't imagine a registrar turning away business because some multinational, multibillion dollar firm carves design out of the scope of registration. I can't imagine that accreditation bodies or forums would be so foolish as to push this policy.

This is a debate that has only begun. There will be tremendous resistance in many companies that are 9002 registered and had no intention of pursuing 9001 (even though they have R&D and/or Engineering functions).

There are many, many, many companies in the Silicon Valley and US that have gone the 9002 route and DELIBERATELY avoided 9001. Do you think that the registrars/accreditation bodies will choose to hold a gun to the head of these guys? This is certainly the current position from the RAB....but I honestly don't think they realize what fight they are about to get into.

It truly will be interesting.......and I think the user community will have a few things to say to those issuing guidance on this subject. I can hear the ringing in my ears...

my 2 cents.

Bill

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Marc Smith
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posted 22 November 2000 05:49 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO 9000 Standards Discussion
Date: Wed, 1 Nov 2000 14:59:21 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/Trudeau/Paten

From: Mike Paten

I totally concur with Pat's comments on this issue:

>From: "Trudeau, Pat" >
> According to ISO/TC 176/SC 2/N 485 (if this version dated 26
> April 2000 is still current) Section 3.3 Permissable Exclusions
> paragraph 3 states "The fact that a specific activity (such as
> Design and Development, or Purchasing) is outsourced, or carried
> out by a different entity, is not in itself adequate
> justification for the exclusion of that activity from the QMS.
> Overall responsibility for and/or coordination of that activity,
> may remain with the organization."

The key issue (to me) is the degree to which the function is "integrated" with your quality system. If the function you desire to "exclude" is inseparable - then you clearly have to include it. Factors that make it difficult to separate functions that are physically or organizationally "housed" together include:

1) the same process inputs (equipment, people, materials, processes) are shared by the function under review and the function you wish to exclude - how do you properly control and manage shared resources?

2) Critical "interfaces" associated with the excluded function are not documented because they are performed by the same person in the included function to whom the documents would go - does it make sense to document interfaces with yourself?

3) Responsibilities and authorities assigned to the excluded function are integral to operations of the included functions - in other words - how much control does the excluded function have over the included functions?

Usually when functions are "housed" together everything gets a little "fuzzy" because there is really only one system at work.; it is for this reason that ISO registrations are usually for an entire facility (versus one or more functions or product lines) - and auditors recognize that even with satellite facilities do the same work - the "system" in place at one facility is often quite different than the system at another facility (even if documented policy/procedures are identical, the degree of implementation and the level of management commitment may differ significantly).

For all these reasons, a company should look to include within the scope of their registration all functions performed at a particular facility. Besides - is it really that much harder to include design? I don't think so.

Mike Paten

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Marc Smith
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posted 22 November 2000 05:51 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO 9000 Standards Discussion
Date: Thu, 2 Nov 2000 16:00:38 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Deibler/Pfrang/Deibler

From: Bill Deibler

Doug,

RAB has been pressured by industry in the past, and by the same companies I'm talking about. There was an initiative to cut down on the number and breadth of ISO 9000 registration assessments that was spearheaded by HP.

There are companies that see ISO registration as a burden and that believe that it doesn't add value. There have been companies that have gone on the record wishing that the registration scheme would disappear. Companies like HP and Motorola have been very outspoken in their criticism of registration schemes.

Do these companies believe in quality? Certainly they do.

Here's the issue, and it's very straightforward. Do companies want to expend funds for additional scope of registration. I believe that they'll see this as extortion on the part of the registration industry. This in turn reflects poorly on the standard. It shouldn't but it does.

Just because a company pursues 9002 versus 9001: 1994 doesn't mean that they're against quality and having a defined set of engineering practices. In many cases they see 9001 registration as burdensome overhead and they don't envision a return on investment. It's not the standard that's the problem as far as they're concerned...it's the lack of value in pursuing registration.

There is a Motorola way, and there is an HP way. Both companies have a number of R&D organizations that are best in class, IMHO.

Let me put another point forward that is ancient history, but relevant. RAB and ANSI put together a committee back in the early 1990s to define and develop a "US version of TickIT". The committee was called SQSR (software quality system registration). The idea was to have a US scheme as an alternative to the UK scheme. That way it would be open to US accredited registrars and would open up the market for the scheme. Unlike the UK scheme, this would not be a mandatory program. The idea was, if there was a market for this scheme, US companies would seek it out.

I was the editor for the SQSR guide, and was very involved in the proposed program. Interestingly enough, there was tremendous resistance in the US software industry to the idea of an alternative/additional program. The feeling was that this would end up being a great burden on the US software industry. Many many arguments were made (some were quite irrelevant and illogical, and some were thoughtful) in opposition to this proposed program.

The resistance to this program was spearheaded by HP. They lobbied hard against it and made their position clear to ANSI and RAB. After public forum to discuss the issues, the proposed program was shelved by ANSI.

So....things happen. Industry will react if and when they see something coming that they believe will cause them undue burden.

There are a lot of sleeping giants....if they choose to wake up, they can make a lot of noise.

now i'm at 4 cents.

deibs

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Marc Smith
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posted 22 November 2000 05:54 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: ISO 9000 Standards Discussion
Date: Thu, 2 Nov 2000 16:08:36 -0600
Subject: Re: Q: Permissible Exclusions ISO9000:2000 /../Scalies/Deibler/Hartman

From: dhartman@phdinc.com

Bill Deibler wrote,
> If development groups are required to be a part of
> registration, a significant number of companies will refuse to
> comply.

My experience is that if there is adamant refusal, then the requirements have probably been wrongly interpreted and/or presented.

I would question how any design function can continually be successful at creating designs that meet the customer's requirements without the following activities taking place:

1. Fulling understanding the customer's requirements;

2. Further defining those requirements into specific design requirements;

3. Documenting the design in some format (e.g. On paper; computer 2D; computer 3D; computer program, etc.)

4. Having even cursory (and perhaps impromtue) discussions within the design function and/or with other functions such as manufacturing, purchasing, suppliers, etc. related to the practicality of the design (at various stages);

5. Comparing the design capability to the customers requested requirements;

6. Verifying that the resultant product meets the customer's requirements (ISO doesn't state that this can't be performed by a function other than those responsible for the design activity);

7. Tracking changes to ensure that we understand why changes were made, to ensure that they were effective, and that changes aren't made on a whim (refer to the history of the original Henry Ford Motor Company), and that all of the appropriate personnel have the latest revisions available (i.e. manufacturing, support functions, customer, etc.).

Additionally, my experience is that there really is NO difference in the design functions between developing hardware or software. Afterall the software code must be assessed to verify if it is in the proper form (e.g. Fortran, C++, DOS, etc.), does it/will it perform the functions required, etc. In fact discussions related to the efficiency of the code (its complexity) typically take place (the customer may want, and is willing to pay for, a Yugo; not a Rolls-Royce with all the bells and whistles).

And if these activities are taking place, then compliance to ISO 9001 consists of documenting (in a simplistic, non-detailed, format such as flowcharts) those activities. Remember ISO 9001 allows you to determine the level of detail, based on the knowledge, experience and training necessary for those responsible for performing the tasks.

Compliance to ISO is NOT about writing War and Peace, nor is it rocket science.

KISS!

David Hartman

*********************************

From: ISO 9000 Standards Discussion
Date: Thu, 2 Nov 2000 16:14:23 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Deibler/Vianna

From: "Vianna, Sidney"

Bill, long time, no seeing. You might be correct that many organizations might refrain from adopting the ISO 9001 model, in it's entirety, if forced to. Time will tell. I hope that they would see the light.

The reality is that too many quality problems are originated or induced for weak design control processes. If organizations are serious about customer satisfaction and product quality, they have to control their design process. I personally do not see anything in subclause 7.3 of FDIS ISO 9001:2000 that would be so overwhelming for organizations to perform.

Unfortunately, many organizations have misconceptions that, if they structure their design process, they will be too slow or bureaucratic to develop a new concept into a commercial viable product. If this happens, is simply because of self inflicted archaic practices.

Time to market is a key aspect for high-tech organizations, very prevalent in Silicon Valley, like you mentioned and I am also very familiar with. However, compliance with ISO 9001 should not slow the design development process, unduly. I have personal experience with many high tech companies, as well, and would like to mention, for example, one prestigious computer manufacturer that I am familiar with. When I first started to assess that organization, a laptop computer life cycle (from market introduction to obsolence) was about 9 months. Now, it is probably down to 4-5 months. This means that they have to be continuously developing the next generation of their computers, and again, they have to bring it to market in a very abbreviated time. They have never complained about ISO 9001 slowing their development process. Actually, the opposite happened. When they started implementing gates, verification and validation points in their processes, they caught many potential problems that, if left in the design, could have meant tremendous losses, because of potential safety problems and huge recalls.

Traditionally, there is a lot of resistance to implementation of ISO 9001 in Engineering functions because they believe that their creativity will be stifled, their freedom will be taken away, etc . . .But these are the same folks that work under the concept that Design change requests (DCRs), Engineering Change orders (ECOs) and similar tools should be used to fix the bugs of underdeveloped design packages. Many organizations operate under this illusion that it is "part of doing business" for design packages to be released for manufacturing, with known bugs in it, and it is natural that Engineering will fix them through these ECOs and DCR's. Let me tell you this:

ECO's and DCR's should only be used (in a perfect world) to enhance the design package, not to fix it. Unfortunately, again, many organizations do not realize the costs and consequences to allow a weak design development process to generate flawed design packages being released for manufacturing. Too bad.

Your comment about your doubts if Registrars and Accreditation Agencies will really crack down on this loophole. That will definitely be interesting to see. If the Accreditors (RAB, RvA, UKAS, etc . . .)do not take a really firm stance on this, I do not see how this aspect will be enforced.

I have been following this thread, and like many other people have pointed out, ISO is working on a document (ISO/TC 176/SC 2/N254) that will assist on the application and exclusion determination. Let's remember, though, that, for the time being, this document is not being evoked by the Accreditors. Let's wait and see how the guidance contained in that document make it's way in the third-party management certification business.

Best Regards

Sidney Vianna

*************************

From: ISO 9000 Standards Discussion
Date: Thu, 2 Nov 2000 16:16:05 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Scalies/Andrews/Scalies

From: "Charley Scalies"

> Charley,
> What if the certified firm has NO control over what the outputs
> of the design facility are? What if the design facility is
> operated as a separate organization - not just physically but
> organizationally as well? What is the case with your
> example?

That is almost precisely the case here. The design facility is the "parent" if you will, though there really is only one corporate entity/profit center. The design arm has little or no sales of its own. I was initially surprised that their registrar would have ever allowed them to limit the scope of their registration under such circumstances but they did.

Charley

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Marc Smith
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posted 22 November 2000 06:05 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Continued in the following thread: https://elsmar.com/ubb/Forum15/HTML/000123.html

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