From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:30 -0500
Subject: Re: Permissible Exclusions /../Salinger/Arbuckle
From: "Donald Arbuckle"
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
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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.
>
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From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:13:47 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Kozenko/Hankwitz
From: "Hankwitz, John"
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)
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From: ISO Standards Discussion
Date: Tue, 15 Aug 2000 09:34:23 -0500
Subject: Re: Permissible Exclusions /../Arbuckle/Schoffman
From: ASchoffm
<< 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
