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  Permissible Exclusions II (Son Of...)

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Author Topic:   Permissible Exclusions II (Son Of...)
Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 22 November 2000 06:02 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Continued from

From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:52:14 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Gleason

From: Carla Gleason (

Bob George wrote:

> Plans are to move our Field Service group, R&D or Design group
> to a temporary location in the interim. This could be as many
> as thirty or as few as six. ... Is there some flexibility in a
> registrars judgement regarding a location separation like this,
> or will our company be summarily required to seek an additional
> certification for this temporary office site?

When I worked for a registrar, our policy was that the scope of registration could be written around any clearly definable business group or function. It could be a corporate support function (e.g. an international corporate purchasing group for purchasing services), an entire large or small business, or a large multi-site corporate division. The key requirements were the ability to clearly define a scope of registration around the functions performed as desired by the client, not the addresses. The same has been true for the registrar for my current employer. We had included a leased warehouse site 13 miles down the road (our "13 mile aisle") for several years until a newer warehouse was built across the street. The warehouse move was invisible in our scope of registration, as the business address was always the main site. Only the registrar's internal documents had to be changed. Your relocation should be similar. Depending on how your scope was written, you may have to revise that, but the same certificate should do.

Carla Gleason


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:52:36 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Andrews /Scalies/Andrews


Charley wrote (in part);
> 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.

I have seen numerous examples of companies that performed design but elected to keep it outside the scope of their registration. Back in 1994 when I questioned this with one of my clients, we ended up contacting a major registrar (who shall remain nameless...suffice it to say that they were located across the 'big pond'). We talked to the individual that headed up their registration services at the time. He explicitly stated that the 4.4 requirement only applied to companies that sold design as a separate product (i.e. architectural firms). I did not see the logic with his statement and did not agree; however, that was the "out" that the client was looking for to exclude the design requirements.

Fortunately, after MUCH persuasion, I was able to convince the client to go for the 9001.

I never have understood why organizations that do design would wish to omit the function from their quality management systems. After all the old saying...stuff in stuff out is painfully true.

Ethan Andrews


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:52:52 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Pfrang/Deibler/Eugenia


Another perspective-

Motorola being against ISO 9k is ancient history (6 or 7 years old). Motorola was very supportive of the rewrite and sat on the TC 176 and Z1 committees and participated in the ISO 9k 2000 rewrite. In fact the VP of Corp Quality at Motorola was an active member (about 4 years ago). In addition Motorola corporate QA members on the VP's staff were also members. I am not sure about recent history as to whether they are still active members.



From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:54:08 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Kozenko


> Plans are

Those are the two most important words in your question. I'd like to believe that any Registrar worth its "salt" would accept the move you described, provided you can evidence "quality planning" as part of the overall plan. If your certification is based on "processes" and not on "location" then you need to plan and control those processes when you do whatever moving is required.

Your job in executing the quality planning for the move is to see to it that the existing certification stretches like silly putty but still covers the processes.

I'm also an avid fan of the "single certificate" approach (versus multiple certificates), just so you know.

David M. Kozenko

[This message has been edited by Marc Smith (edited 22 November 2000).]

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 22 November 2000 06:09 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
More thoughts:

From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:55:22 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Hankwitz

From: "Hankwitz, John"


Your quality system has been registered to ISO 9001. It doesn't mention departments, job functions, or brick and mortar. There should be no effect on your registration.

However, make sure you have put together a quality plan for your expansion. How will you make sure your customers will continue receiving good product while you are in transition?

John Hankwitz


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:55:30 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Andrews


Will the relocated group(s) still have access to the present QMS documentation (procedures, work instructions, etc.)? If they will then I don't see any problem with them being contained under the present QMS system "umbrella". Your registrar may wish to list the off-site addresses separately in their audit reports (for clarity), but I don't think that separate registrations are necessary.

Ethan Andrews


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:55:38 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Paten

From: Mike Paten


It's completely up to your registrar - the fine print in your contract with your registrar requires you to advise them when significant changes to your system occur. Whether (or not) you will need to be "recertified" will be determined by the impact of the reorganization on your quality system - if your system changes significantly - you will need a complete system audit.


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:55:59 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Scalies

From: "Charley Scalies"

The system in place at the location, not the location, is the governing factor. Assuming your system remains essentially unaffected, then you may/should be facing nothing more than an amendment the scope of your current certificate and not a new certificate. Undoubtedly your registrar will want to visit and audit the activities at the new locations.

Charley Scalies


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:56:22 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Summerfield

From: George Summerfield

Hi Bob:

This is only my opinion, but... if your people are going to perform the same duties (and processes and procedures) that they did before the move, but in the new location(s) - no problem. Just make sure that you fill the new gaps with procedures for communication and co-ordination with the satellite offices, and notify your consultant and registrar about the move(s). How can any business-minded body have a problem with growth?



From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:56:11 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Monnich/George/Monnich

From: "Herbert C. Monnich, Jr."

Ask your registrar. There are a large number of variables. Is the temporary area next door, 2 blocks away, 200 miles away or in another area of the country. Your QMS needs to address any problems that you might anticipate, if any. Your registrar only needs to make sure that your QMS is being followed.

Herbert Monnich


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:56:53 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /Peracchio/Hartman

From: dhartman

Darlene, I believe that you've answered your own question in that you stated that
> In general, we are... developing a product to match a
> competitor's.

The key word in your quote is "developing". ISO/DIS 9001:2000 (sorry I don't have the FDIS yet) section 7.3 is titled "Design and/or Development", and I believe that you'll find that the controls defined are applicable to "developing a product to match a competitor's".

Regarding handling reluctant organizations: I recommend approaching the organization by recognizing the positive attributes of what they are doing, commending them for the informal processes/methods that they have in-place, and educating them on the benefits of documenting those processes in manner that is not too specific to impact their "creativity", but yet could benefit someone "new" to the organization. I would recommend the use of flowcharts, videos, (be creative, for processes do NOT have to be verbiage). In-fact our company HAD so much verbiage at one time that virtually none of it was being used (it was too confusing, and in a fast-paced production environment no one has the TIME to spend reading text).

Remember: You attracted more flies with honey, than with

David Hartman


From: ISO 9000 Standards Discussion
Date: Fri, 3 Nov 2000 12:57:05 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /Peracchio/Summerfield

From: George Summerfield

Hi Darlene:

First, let me start by saying that you cannot and should not try to exclude Design Control; especially when you clearly have a R&D department and perform the function. As for the problem you are having - try the approach that I used last year...

We have the largest R&D department I've ever seen; especially since this is a scientific R&D facility. Having said that, I have found that if what you are trying to do is standardize processes so that they are repeatable, conduct business to make money, or do anything else that a scientist considers "nos" (noise as opposed to signal) to their particular study/project - then all that you are doing is wasting their valuable time. They only panic and look for the business-minded people when funding starts to disappear from their project before they have found a solution. I had a wonderful time just trying to get scientists to listen to me when I was trying to sell them on the benefits of process management; but finally I figured out an angle. Whether or not you agree with what I say here is irrelevant; the point is that it worked ;-)

I managed to get an assembly of scientists and engineers at the facility together and speak to them about how the Business environment - after many decades of doing things wrong - turned around and took a lesson from Science, in order to make business work properly. After all, the fathers of quality were scientists - Dr Deming and Dr Juran were scientists in their own right. Anyway, I drew a line down the center of a board and compared "Scientific Research" to "Business Process". Here's how they equate:

Business / Scientific

Control Input = Control Test Subjects: if you don't control the subject of your study then your entire research is invalid. Control Process = Control Research Process: do this with documented procedures; because if you cannot show that the research is repeatable then it will not stand up to scrutiny in the scientific community when you publish your paper. Calibration of Test Equipment = Validation of their research data. They'll especially like this! Control Output = Controls required on your newly developed substance for storage, handling, etc, etc. Customer Service = Their concern for who will use the result of their research, how, and why.

Its very easy to draw the appropriate lines for the scientists and engineers to see where the elements of ISO9000 are based upon what is already being done in the R&D environment. Unfortunately, the scientist will say that this is what they are doing all of the time anyway. Response: "Yes sir/ma'am; and now we just want to write it down so that new personnel coming in will be able to work-in smoothly and follow your existing processes without incurring too much error into your already stable processes. This records keeping stuff will also make it much easier for you to access any proof that you require for your studies later."

In preparation for this, have an internal letter of agreement handy for them to sign to close the deal after the presentation. This is required because scientists quickly forget what they agreed to, very soon after delving back into their project/study. Thereafter, you have the signed agreement to waive, when necessary, as you deal with their subordinates to work the plan. IMHO - DO NOT go back to bother the head scientist unless you really, REALLY have to. Just let the improvement in the way that things work sink in through the process of osmosis for them. Ask them how things are working out over coffee; that sort of thing.

Best of luck...


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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 22 November 2000 06:24 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
More in /pdf_files/

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 22 November 2000 06:39 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: Mon, 13 Nov 2000 12:25:17 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /Reid/Scalies/Marr

From: Jeremy Marr

> . . . . Their registrar is now saying that with the
> introduction of the new standard, they "must" include design
> control. Certainly, their registrar can refuse to recertify
> them unless they include design control. But will all
> registrars be so demanding? I am somewhat interested to see
> where this will all end up. . . .
> Charley Scalies

ISO have clarified what they consider to be permissible exclusions in a document entitled (Draft) Guidance on ISO 9001:2000 clause 1.2 "Application". This can be found on the ISO web page ( ) (through the red banner marked ISO 9000 Revisions - Updated transition guidance- and under New Supporting Documents).

In that document they provide examples of what they regard as permissible. One of the examples relates to an organization who chose 9002 even though they designed product. In the example, the registrar was one of the not so demanding ones and did not require them to include the design process - but the organization chose to include it anyway "because it does in fact carry out this activity and the activity does affect its ability to meet customer requirements. Also, it wants to be able to claim conformity with ISO 9001:2000, and the exclusion of the design and development activity would not allow it to do so. "

So who is going to police that one?

Jeremy Marr

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA

posted 22 November 2000 07:29 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: Mon, 20 Nov 2000 13:36:30 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 .../Scalies/Russell/Deibler

From: Bill Deibler

> From: "J.P. Russell"
> In an attempt to limit confusion, the word SCOPE is used to
> identify the location, facility, product and services under
> the Quality Management System. An organization cannot exclude
> clauses of ISO 9001:2000 by a scope statement. It was never
> intended that organizations could decide to exclude, for
> example, design as part of a scope statement. The word
> APPLICATION is used when discussing the tailoring or
> identification of clauses that will be excluded from the
> organizations Quality Management System. The starting point
> for registering to ISO 9001:2000 is that all clauses apply
> unless the organization has provided sufficient justification
> to their registrar organization.
>JP Russell

List Members,

In another attempt to limit the confusion, I passed along JPR's response to my business partner, Bob Bamford, and he felt it worthwhile to weigh in. His response follows:

ISO/FDIS 9001 Clause 1 is titled "SCOPE". Clause 1.1 is titled "General". Clause 1.2 is titled "APPLICATION".

"Scope" is short hand for "scope of application" so (once again) ISO shoots itself in the foot by tossing terms around.

Clause 1 contains legitimate scope information in both paragraphs 1.1 and 1.2. In the last two paragraphs, 1.2 also defines the requirements for claiming conformity with the standard. This arguably has nothing to do with scope of application of the standard, but the information it contains is necessary because of the elimination of 9002 and 9003.

Clause 4.2.2 states that the quality manual includes "the scope of the quality system, including details of and justification for any exclusions (see 1.2)".

In addition, the registration process refers to the scope of the registration and the scope statement on the registration certificate. The registrar requires that the scope statement unambiguously communicate to any potential customer what was assessed (e.g., processes, products, services, locations) and found to be operating in compliance with the requirements of ISO 9001, ISO 9002, or ISO 9003.

It appears that JPR is mixing paragraphs 1.2 and 4.2.2 in ISO 9001 and an element of the registration process.

The SCOPE statement in the quality manual will (as required by clause 1.2) define the exclusions. This would, presumably, be carried forward onto the registration certificate - if the organization chooses to become registered, which is not required to claim conformity with the standard.

If the organization chooses to seek registration, the scope statement will define the scope of the assessment and, by omission, those functions and requirements which have been excluded.

In light of these statements in ISO 9001, I'm not sure what JPR means by "exclude clauses of ISO 9001:2000 BY a scope statement".

I suspect the heart of the "confusion" is related to the currently unanswered question of whether ISO intends to continue to allow Design to be omitted in organizations that have both design and manufacturing (e.g., equivalent to ISO 9002).

Whilst some are taking the ivory tower, philosophically-justified position that such an exclusion violates the integrity of the standard, the reality is that, in many cases, once a product is established and proven, customers care most about the manufacturing process. There are exceptions, like software product, for which manufacture and engineering cannot be considered as separate, significant processes as they relate to product quality.

One constraint imposed on the revision was to make the transition "easy" and "not require the rewriting of an organization's quality system documentation" [see ISO/TC176/SC 2/N 415, Section 1.5]. It appears that requiring organizations to add the design function if they have it, does not seem to be a defensible or intended position. It will make organizations think twice about registration.

Imposing the "all-or-nothing" requirement would raise two significant obstacles to the use of the standard. First, it would move ISO 9001 out of alignment with the regulated products directives of the European Union, which currently accept ISO 9002. If ISO decides to go the all-or-nothing route, I wonder if registrars will offer an alternative service verifying compliance with enough of ISO 9001 to satisfy the directives, even if the subset is not enough to satisfy elevated requirements for claiming conformance to the standards.

Secondly, the "all-or-nothing" interpretation prevents phased implementations, in which a progressive organization achieves compliance - and registration - as a pilot, pioneer, or prototype for a larger organization. The pioneer might be hardware engineering in an organization that includes software engineering, manufacturing in an organization that includes engineering, or telephone customer support in an organization that includes engineering and manufacturing.

Resolving the "scope" problem requires that ISO define "organization" in the context of exclusion.

Fortunately, the transition rules of the International Accreditation Forum (IAF) provide three years for registrars and industry to sort this out. Unfortunately, it has to be sorted out.



From: ISO 9000 Standards Discussion
Date: Mon, 20 Nov 2000 13:39:04 -0600
Subject: Re: Permissible Exclusions ISO9000:2000 /../Reid/Pfrang /Goetzinger

From: Tom Goetzinger

Doug Pfang said, in part:
>"The answer is, "because that isn't what the company has chosen
> to do, it isn't what the company is willing to pay for, and it
> isn't the registrar's right to dictate the scope of the
> company's registration."
> Consider:
> What if the company had centralized manufacturing at
> one location, but had distributed design work at ten
> different locations (maybe even in different
> countries). Do you think the registrar should have
> the right to refuse to registrar the one manufacturing
> location unless the company agrees to pay the
> registrar to certify all eleven locations? I sure
> don't."

Guess we disagreee on that. As in any Buyer - Seller relationship, with appropriate notice, either party can choose not to continue the relationship. I think that might be a shortcoming of the 2000 version; at least with the 1994 version, it was obvious if your design function was certified or not. Suspect there will be all kinds of shanigans to try to convince registrars that they don't need to control the design function but they should be ISO 9001 certified. Hopefully, it won't be allowed.

Tom Goetzinger

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