Expanding A Registration Overseas

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
> From: Lisa Silvestri
> Sent: Wednesday, February 02, 2000 8:46 AM
> To: 'qs9000 quality.org'
> Subject: Help
>
> Currently the company I work for is QS9000 certified here in the
> states, but we recently opened a sales office and warehouse over in
> the U.K. We are going for certification over there with us here listed
> as the Corporate Headquarters and the warehouse over there as a
> satellite. Does anyone have any recommendations as to how to
> incorporate them into my quality manual and my Level II procedures?
>
> Lisa...

---------------snippo---------------

To: 'Lisa Silvestri'
From: Brewer, Hershal

Lisa,

We are already doing the very thing you describe. We have a corporate headquarters in the U.S. with a certificate, a Minnesota facility with what our Registrar calls an Appendix Certificate, and our French and other U.S. facilities will also receive an Appendix Certificate once they are registered.

Your Registrar should be able to provide the guidance for the process. Each facility with an appendix goes through its own registration audit. The audit covers the Quality Manual (we use only one QM company-wide), corporate procedures that have been adopted by the appendix facility, and any local procedures that the appendix facility creates. These are compared to the Standard per any other registration audit. The Appendix Certificate has the same cert number as the corporate cert, but has the local address of the appendix facility.

Our Registrar's assigned auditor is the coordinator for the Registrar's audits. The local facility has an assigned auditor to perform the audits. The local auditor provides the results to the coordinating auditor to provide to us at headquarters. The local facility schedules their audits and also gets the results. The billing comes through the corporate headquarters.

Now, putting them into your procedures is simple. Put a statement in the Quality Manual that requires satellite facilities to adopt the corporate Quality System including the QM, and allows the local facility to either have lower level procedures to describe their situations or adopt the corporate procedure.

If I can offer any extra help, let me know.

Hershal Brewer
Newport Corporation
 
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
Any thought of them just registering each facility on its own? They could use your docs as a basis and modify to fit their own needs. I'm not sure there are any real benefits of all being on the same registration, and there is the downside that if any facility has a problem with its registration, that problem directly affects all of the organization as if they were the facility that had the problem. Local ownership of the docs also would make life easier and more responsive to any changes that need to be made to improve the system.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Some related thoughts:

From: ISO Standards Discussion
Date: Mon, 10 Jan 2000 08:57:37 -0600
Subject: Re: Multiple offices / Buchanan/Kozenko

From: Write9000

Listers -- this one reads harsh, but I couldn't help it. The lack of proper understanding (I remember when I had this lack of misunderstanding, so this is a qualified statement) comes from not understanding what a Registrar does in the overall scheme of things, and how treacherous the ISO world can be with "not enough" internal training...

<<Buck Buchanan wrote:
<< Our Dallas office (Telecom and computer cables manufacturing) is working
on ISO9001 registration with completion expected by February. The home plant
(Chicago) may not elect to become ISO9001 registered. >>

Chicago must be treated (by Dallas) as a "supplier" under the Purchasing clause; bet Chicago will love that, especially "supplier audits." Once your Registrar finds this weak spot, Dallas will have a difficult time maintaining a quality life.

<< We have changed our name from Southwest NAC, a division of North American
Cable, Inc. to North American Cable Company, Inc., Southwest Division. So now
we are both the same company -- Dallas will be ISO9001 registered, Chicago
not registered.>>

Full Stop: You could "slip one by" the various Secretaries of State by signing up under Texas and Illinois Corporations Commissions using the same name, yet having separate offices, officers and directors, bank accounts, payrolls, and the like -- a "trademark infringement" on your own firm, as it were... this doesn't sound quite up and up to me at first read; in fact, I remember my first "real" job right now, which involved driving the truck to the fish market... Clarify please, are you incorporated or organized under one charter, or two separate charters? Or in other words, what's the actual chain of liability, from the customer up?

<< Many of our products are sold and shipped through the Chicago office, but
manufactured here in Dallas (Chicago does very little manufacturing). My
question from a meeting yesterday is: What have other companies with
branches (some registered, some not) done in these cases? >>

The multi-site "same name" companies that I have dealt with thought this one through (with a little help from their consultant <g>) and decided that it's "all or nothing" in terms of displaying any kind of ISO900x banner to the public, until each and every one of the sites was included in a registration scope. The underlying thinking was, "If we get caught by the marketplace pulling the wool over people's eyes, it would only harm the company twice as bad as any improvement from ISO registration would help it." Another approach, though, would be to use a map that color codes those firms that are, and are not, ISO registered. Blue and Green would fit best in this case too, because colorblind people generally can't differentiate between those two, and the message I'm getting from your post is that this is what your firm wants...

<< Can our invoices and other documents all carry the ISO logo in a
prominent location or must we list both addresses on the documents with the
logo only alongside the address that's registered? >>

The former would be a violation of the Registrar's policies (promulgated by the Registrar's Registrar...) as it would clearly mislead anyone who didn't have inside knowledge that only half of the two addresses shown were actually registered. Why advertise a lie as part of your quality system? When your Registrar found out you were doing things this way, the Salvation Army would really make a windfall on the paper you'd have to throw away; every printer in town would be happy to, as you re-printed everything correctly. Do it right the first time. And, don't ask your Registrar about this one in advance -- it will telegraph the fact that a strict audit would be in order.

<< Can all products manufactured in the registered plant carry ISO9001
certification, regardless of the route taken to the customer (through the
Chicago office)? >>

If products bear an ISO Registration mark (like, a written report by a consultant, which would bear the Registration Mark on the Letterhead), it must be clearly shown that the mark refers to the company's Quality Management System and specifically NOT to the product itself. If a soup can bears a Registration Mark then there's trouble -- soup cannot be ISO Certified/Registered; the company's quality system who makes the soup can be ISO Certified/Registered.

All Registrars have form letters that (essentially) say "refer to the guidelines on Registration Mark use that you received upon your initial Certification, and (without so much as a whimper) destroy all non compliant printings, postings and unauthorized useages immediately. your Registrar may elect to suspend your Registered status as you accomplish this trash task, and don't believe everyone in the industry won't find out about it.

Products are not certified; Entities' Quality Management Systems are certified. There is no middle ground or grey area, and any money your firm would like to bet on a closer exploration of that precept would be better spent as a donation to United Way, the American Red Cross, etc.

With this kind of thinking running rampant in your organization, maybe someone can wrestle its essence on down to the surface of a new no-stick fry pan. You'd make millions. <g>

David Kozenko

--------------snippo-------------

From: ISO Standards Discussion
Date: Mon, 10 Jan 2000 09:31:32 -0600
Subject: Re: Multiple Offices /Buchanan/Naish

From: PNaish

Buck,

I have had several clients who were registered in some sites and not in others: a couple were distributors who registered their distribution sites and not their sales offices and a couple who did assembly and likewise not their sales office.

First off, the product is not certified in any case. What you have registered is the quality system that relates to everything from the design to the sales of the product. So it would be incorrect in any advertising or on the product to say it is ISO certified to ISO9001. However, you may advertise that the product is designed and built in an ISO9001 registered facility. If the product is manufactured elsewhere you have to be careful what you are saying unless that manufacturing is within the scope of your registration certificate. You can not for example indicate that product which is designed in the southern facility but which is built in Chicago is under the registration unless Chicago is in the scope (and therefore registered) or unless your scope and the procedures treat the Chicago facility as a supplier.

Only sales offices within the scope of the certificate may also say they are registered. For example let's say you have a sales office in Miami, Florida and one in San Diego, California. You can not indicate in your advertising that they are registered as they are not. You also can not put ISO 9000 registered on their business cards unless they are in the audit scope.

However, you can do what most companies do in their advertising which is spell out which facility or facilities are registered. Say you have a full page ad in a business journal. You can show all sites but place an asterisk beside those which are inside the scope of your registration. At the bottom you indicate that this site or sites is/are registered to ISO9001. I have seen companies who have received letters from their registrars for not correctly spelling this out in the advertisement. In addition I have heard but not seen companies who only registered one or two of the product lines and yet implied all lines were within the scope. They also received letters from their registrar to stop or their certificate would be recalled.

The best bet is to contact your registrar and get a copy of their agreement that they send regarding what and how you can advertise. If you have already made a contract with a registrar they should be able to send you this information. If you have no contract you may have to wait until you have one to get this information from them.

One other word of warning only: I have seen one company sue another company and win because they falsely indicated registration for a product line they did not have. They did so because they lost an existing multi-million dollar contract due to the false advertisement. I believe it was settled out of court but the results were big and the contract was re-awarded to the company who sued.

Phyllis

-------------snippo------------

From: ISO Standards Discussion
Date: Mon, 10 Jan 2000 10:18:13 -0600
Subject: Re: Multiple offices /Buchanan/Kozenko/Pfrang

From: nicolet.com (Doug Pfrang)

><<Buck Buchanan wrote:
>> Our Dallas office (Telecom and computer cables manufacturing) is working
>>on ISO9001 registration with completion expected by February. The home plant
>>(Chicago) may not elect to become ISO9001 registered. >>

><<In reply, David Kozenko wrote:
>Chicago must be treated (by Dallas) as a "supplier" under the Purchasing
>clause; bet Chicago will love that, especially "supplier audits." Once your
>Registrar finds this weak spot, Dallas will have a difficult time maintaining
>a quality life.

I believe the above answer is wrong. The posting states that products are manufactured in the Dallas plant and that some products are sold and shipped through the Chicago office. Accordingly, the Chicago office (if anything) appears to be a customer, not a supplier, to the Dallas plant.

><<Buck Buchanan wrote:
>>We have changed our name from Southwest NAC, a division of North American
>>Cable, Inc. to North American Cable Company, Inc., Southwest Division. So now
>>we are both the same company -- Dallas will be ISO9001 registered, Chicago
>>not registered.>>

><<In reply, David Kozenko wrote:
>Full Stop: You could "slip one by" the various Secretaries of State by
>signing up under Texas and Illinois Corporations Commissions using the same
>name, yet having separate offices, officers and directors, bank accounts,
>payrolls, and the like -- a "trademark infringement" on your own firm, as it
>were... this doesn't sound quite up and up to me at first read; in fact, I
>remember my first "real" job right now, which involved driving the truck to
>the fish market... Clarify please, are you incorporated or organized under
>one charter, or two separate charters? Or in other words, what's the actual
>chain of liability, from the customer up?

I believe the above answer is also wrong. It makes no difference whether the two companies are organized under the same charter or not. What matters is that the registered facility uses the ISO logo in a manner which causes no confusion (among either company's customers) as to which facility is registered and which one is not. Their underlying corporate structure is irrelevant.

><<Buck Buchanan wrote:
>>Many of our products are sold and shipped through the Chicago office, but
>>manufactured here in Dallas (Chicago does very little manufacturing). My
>>question from a meeting yesterday is: What have other companies with
>>branches (some registered, some not) done in these cases? >>

><<In reply, David Kozenko wrote:
>The multi-site "same name" companies that I have dealt with thought this one
>through (with a little help from their consultant <g>) and decided that it's
>"all or nothing" in terms of displaying any kind of ISO900x banner to the
>public, until each and every one of the sites was included in a registration
>scope. The underlying thinking was, "If we get caught by the marketplace
>pulling the wool over people's eyes, it would only harm the company twice as
>bad as any improvement from ISO registration would help it." Another
>approach, though, would be to use a map that color codes those firms that
>are, and are not, ISO registered. Blue and Green would fit best in this case
>too, because colorblind people generally can't differentiate between those
>two, and the message I'm getting from your post is that this is what your
>firm wants...

I believe the above answer unreasonably restricts what the Dallas and Chicago plants can do. If the Dallas plant is registered, then it can promote its facility as being registered as long as its promotional efforts do not falsely suggest that the registration also applies to other, unregistered, plants. In addition, the Chicago plant can also promote the Dallas plant's products as being manufactured in an ISO-9000 registered facility even if the Chicago plant is not registered -- as long as the Chicago plant makes clear that they are referring to the Dallas plant and not to themselves. If the promotional materials are truthful and unambiguous, then there will be no question of "pulling the wool over peoples' eyes" and both company's actions would be permitted.

Doug Pfrang
 
Thread starter Similar threads Forum Replies Date
J Expanding our Company's AS9100D Registration Scope and Location AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
F Expanding a Company's Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 5
T CE Certification Strategy - Expanding the validity of certificate EU Medical Device Regulations 1
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
F Business expanding - Campus vs Multi Site Certification Structure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
W Substitute for Expanding Arbors General Measurement Device and Calibration Topics 3
K Expanding a Laboratory Calibration Scope General Measurement Device and Calibration Topics 3
J Expanding the c = 0 Small Lot Squeglia Table Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
J Which certificate do we need? - Expanding in the medical product market Other Medical Device Regulations World-Wide 9
C Controlling QMS - We are expanding globally and want to keep our QMS Confidential Quality Manager and Management Related Issues 20
D Expanding the Scope of a Calibration Laboratory General Measurement Device and Calibration Topics 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 0
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
J Brazil Registration Holder Other Medical Device Regulations World-Wide 0
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Establishment Registration and Device listing - Wording of 807.20 (a) (6) Medical Device and FDA Regulations and Standards News 3
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
O Cancellation of Registration from ARTG - Sponsor Unresponsive Other Medical Device Regulations World-Wide 0
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
T Reaction Plan To Drive suppliers to IATF 16949 registration IATF 16949 - Automotive Quality Systems Standard 4
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 10
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
S Which department manages Establishment Registration, Device Listing and GUDID? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
M Courses / Workshops on Registration of Medical Devices WW Other Medical Device and Orthopedic Related Topics 2
L Payment for Establishment Registration and Device Listing US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom