Re: ISO 9000 and Sales Tenders in the EMEA

2010-01-19 Thread emc-p...@ieee.org
In message <002301ca9925$51aa37b0$d600a...@tamuracorp.com>, dated Tue, 
19 Jan 2010, Brian O'Connell  writes:

>Will be looking for Mr Woodgate's reply to this, as I have not been 
>able to understand the value of the ISO 9k dance.

I'm not an expert on ISO 900, which is why I keep on good terms with a 
colleague who is!

I can see the point that an R&D department may not need certification, 
provided there are adequate safeguards that the manufactured products 
perform as intended.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
I should be disillusioned, but it's not worth the effort.

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RE: ISO 9000 and Sales Tenders in the EMEA

2010-01-19 Thread emc-p...@ieee.org
Will be looking for Mr Woodgate's reply to this, as I have not been able to
understand the value of the ISO 9k dance.

FWIW, last year I requested permission from the corporate office to stop our
wonderful visits to (only) the engineering dept from the registrar. So we
polled our customers, distributors, etc. None cared if the engineering dept
did not have it, but were happy as long as the factories had the paper. In any
case, the big boss would not let us drop engineering from the ISO dance - so
we continue to waltz with our two left feet.

Brian 

 > -Original Message-
 > From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of John
 > Woodgate
 > Sent: Tuesday, January 19, 2010 12:02 AM
 > To: emc-p...@ieee.org
 > Subject: Re: ISO 9000 and Sales Tenders in the EMEA
 > 
 > In message <580243.62817...@web113504.mail.gq1.yahoo.com>, 
 > dated Mon, 18 
 > Jan 2010, peter merguerian  writes:
 > 
 > >I am told that ISO9000 is a  must-have" to participate in 
 > sales tenders 
 > >in Europe, Middle East and Africa.
 > > 
 > > Is anyone familar with an alternative to ISO9000 certification for 
 > >companies not able to afford ISO9000 certification but who 
 > would like 
 > >to penetrate these markets?
 > 
 > I doubt it, but I will ask my colleague who is a specialist 
 > in ISO 9000 
 > about possible lower-cost routes to certification.
 > -- 
 > OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
 > John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK

-

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RE: [PSES] ISO 9000 and Sales Tenders in the EMEA

2010-01-19 Thread emc-p...@ieee.org
Peter

 

ISO9000 is a standard requirement on many tenders – whether having it
actually means anything in reality can be debated ‘till the cows come home J

 

When you say “not able to afford” – how big is the company and how much
have they been quoted?

 

There are ISO9000 schemes designed for micro-companies which cost <£1k p.a.

 

Regards

Charlie

 

From: peter merguerian [mailto:pmerguerian2...@yahoo.com] 
Sent: 19 January 2010 01:24
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] ISO 9000 and Sales Tenders in the EMEA

 

Dear Group Members,

 

I am told that ISO9000 is a  must-have" to participate in sales tenders in
Europe, Middle East and Africa.

 

 Is anyone familar with an alternative to ISO9000 certification for companies
not able to afford ISO9000 certification but who would like to penetrate these
markets?

 

Thanks,

 

Peter Merguerian

 

 

 


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Re: ISO 9000 and Sales Tenders in the EMEA

2010-01-19 Thread emc-p...@ieee.org
In message <580243.62817...@web113504.mail.gq1.yahoo.com>, dated Mon, 18 
Jan 2010, peter merguerian  writes:

>I am told that ISO9000 is a  must-have" to participate in sales tenders 
>in Europe, Middle East and Africa.
> 
> Is anyone familar with an alternative to ISO9000 certification for 
>companies not able to afford ISO9000 certification but who would like 
>to penetrate these markets?

I doubt it, but I will ask my colleague who is a specialist in ISO 9000 
about possible lower-cost routes to certification.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
I should be disillusioned, but it's not worth the effort.

-

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ISO 9000 and Sales Tenders in the EMEA

2010-01-18 Thread emc-p...@ieee.org
Dear Group Members,
 
I am told that ISO9000 is a  must-have" to participate in sales tenders in
Europe, Middle East and Africa.
 
 Is anyone familar with an alternative to ISO9000 certification for companies
not able to afford ISO9000 certification but who would like to penetrate these
markets?
 
Thanks,
 
Peter Merguerian
 
 
 

-

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Re: ISO 9000 Document

2009-03-04 Thread emc-p...@ieee.org
Grace,
 
Per Japan, if the radio component manufacturer does not have ISO9000, you can
submit the quality manual for review
 
Peter Merguerian

--- On Tue, 3/3/09, Grace Lin  wrote:


From: Grace Lin 
Subject: ISO 9000 Document
To: emc-p...@ieee.org
Date: Tuesday, March 3, 2009, 8:56 AM


Dear Members,
 
Could someone please advise what documents are required per ISO 9000 
(ISO
9001?)?  This seems off topic for EMC engineers.  However, a production
quality system certificate (or alternative document) is required to obtain
Type Certificate for radio devices per MIC Japan.
 
A quick Google search found a link htt
://www.iso.org/iso/iso_catalogue/manage
ent_standards/iso_9000_iso_14000/iso_90
1_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm.  Is
this the best list of the document required by ISO 9000?
 
Thank you and look forward to hearing from you.
 
Best regards,
Grace Lin
 
 
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ISO 9000 Document

2009-03-03 Thread emc-p...@ieee.org
Dear Members,
 
Could someone please advise what documents are required per ISO 9000 (ISO
9001?)?  This seems off topic for EMC engineers.  However, a production
quality system certificate (or alternative document) is required to obtain
Type Certificate for radio devices per MIC Japan.
 
A quick Google search found a link http
//www.iso.org/iso/iso_catalogue/managem
nt_standards/iso_9000_iso_14000/iso_900
_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm.  Is
this the best list of the document required by ISO 9000?
 
Thank you and look forward to hearing from you.
 
Best regards,
Grace Lin
 
 
-

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RE: ISO 9000

2002-06-20 Thread Gregg Kervill


I think you will find that this dependant upon the product type and ISO 900
may not be sufficient.


Gregg Kervill DipIM, MIMgt, MIEEE

VP Engineering
Test4Safety.com Inc
PO Box 310,
Reedville, VA
22539. USA

Phone  ( 804) 453-3141
Fax(804) 453-9039



--Original Message-
-From: owner-emc-p...@majordomo.ieee.org
-[mailto:owner-emc-p...@majordomo.ieee.org]On Behalf Of
-ron_well...@agilent.com
-Sent: Wednesday, June 19, 2002 10:25 AM
-To: marti...@appliedbiosystems.com; emc-p...@majordomo.ieee.org
-Subject: RE: ISO 9000
-
-
-
-Hello Martin,
-
-If you are a medical device manufacturer, to comply with the
-European Medical Device Directive, you have to have ISO 9000
-accreditation. Otherwise, ISO 9000 compliance is a
-market/customer requirement, not a regulatory requirement.
-
-Regards,
-+=+
-|Ronald R. Wellman|Voice : 408-345-8229   |
-|Agilent Technologies |FAX   : 408-553-2412   |
-|5301 Stevens Creek Blvd.,|E-Mail: ron_well...@agilent.com|
-|Mailstop 54L-BB  |WWW   : http://www.agilent.com |
-|Santa Clara, California 95052 USA|   |
-+=+
-
-
--Original Message-
-From: marti...@appliedbiosystems.com
-[mailto:marti...@appliedbiosystems.com]
-Sent: Tuesday, June 18, 2002 7:24 PM
-To: emc-p...@majordomo.ieee.org
-Subject: ISO 9000
-
-
-
-Greetings,
-
-Several years ago most manufacturing companies were getting
-evaluated to
-ISO 9000 standards.  Since that time, there have been some
-revisions to the
-standards.  Does your company still spend time and money
-dealing with ISO
-9000 and it's revisions.  If so, why.  If not, why not?
-
-I realize this subject is not directly related to product
-safety/EMC, so,
-if you like,  you can email me directly with your responses.
-
-All responses are appreciated.
-
-Regards
-
-Joe Martin
-EMC/Product Safety Engineer
-Applied Biosystems
-marti...@appliedbiosystems.com
-
-
-

-This message is from the IEEE EMC Society Product Safety
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RE: ISO 9000

2002-06-19 Thread ron_wellman

Hello Martin,

If you are a medical device manufacturer, to comply with the European Medical 
Device Directive, you have to have ISO 9000 accreditation. Otherwise, ISO 9000 
compliance is a market/customer requirement, not a regulatory requirement.

Regards,
+=+
|Ronald R. Wellman|Voice : 408-345-8229   |
|Agilent Technologies |FAX   : 408-553-2412   |
|5301 Stevens Creek Blvd.,|E-Mail: ron_well...@agilent.com|
|Mailstop 54L-BB  |WWW   : http://www.agilent.com |
|Santa Clara, California 95052 USA|   |
+=+


-Original Message-
From: marti...@appliedbiosystems.com
[mailto:marti...@appliedbiosystems.com]
Sent: Tuesday, June 18, 2002 7:24 PM
To: emc-p...@majordomo.ieee.org
Subject: ISO 9000



Greetings,

Several years ago most manufacturing companies were getting evaluated to
ISO 9000 standards.  Since that time, there have been some revisions to the
standards.  Does your company still spend time and money dealing with ISO
9000 and it's revisions.  If so, why.  If not, why not?

I realize this subject is not directly related to product safety/EMC, so,
if you like,  you can email me directly with your responses.

All responses are appreciated.

Regards

Joe Martin
EMC/Product Safety Engineer
Applied Biosystems
marti...@appliedbiosystems.com



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Re: ISO 9000 --- Or ISO/IEC 17025

2002-06-19 Thread Larry Gradin

Martin,

The key issue is the competence of the testing and demonstration of
compliance to both EMC and Product Safety requirements.

The standard to use is ISO/IEC 17025, "General Requirements for the
Competence of Calibration and Testing Laboratories".

This is the foundation for acceptance of testing worldwide including most
mutual recognition agreements.  As recognized by various goivernments and
and industries as well as ISO and IEC in the Introduction to ISO/IEC 17025:

"Certification against ISO 9001 and ISO 9002 does not of itself demonstrate
the competence of the laboratory to produce technically valid data and
results.
The acceptance of testing and calibration results between countries should
be facilitated if laboratories comply with this International Standard and
if they obtain accreditation from bodies which have entered into mutual
recognition agreements with equivalent bodies in other countries using this
International Standard.  The use of this International Standard will
facilitate cooperation between laboratories and other bodies, and assist in
the exchange of information and experience, and in the harmonization of
standards and procedures."

Hope this helps.  ISO 9000 was not the answer years ago and it still is not.


Larry Gradin

***
*  Larry Gradin, PE, QMS-LA
*  Email:  lgra...@integrity-solutions.org   &  l.gra...@ieee.org
*  Integrity Solutions Group, Inc.
*  6419 Bridgewood TerraceBoca Raton, FL 33433 USA
*  Phone 561-395-6007Efax: 978-285-6589
*  Web Page http://www.Integrity-Solutions.org
___
Remember -  Quality depends on Integrity, Attention To Detail,
 Cost-Effective Action, and Commitment -- not buzzwords.
*






- Original Message -
From: 
To: 
Sent: Tuesday, June 18, 2002 10:23 PM
Subject: ISO 9000


>
> Greetings,
>
> Several years ago most manufacturing companies were getting evaluated to
> ISO 9000 standards.  Since that time, there have been some revisions to
the
> standards.  Does your company still spend time and money dealing with ISO
> 9000 and it's revisions.  If so, why.  If not, why not?
>
> I realize this subject is not directly related to product safety/EMC, so,
> if you like,  you can email me directly with your responses.
>
> All responses are appreciated.
>
> Regards
>
> Joe Martin
> EMC/Product Safety Engineer
> Applied Biosystems
> marti...@appliedbiosystems.com
>
>



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ISO 9000

2002-06-19 Thread MartinJP

Greetings,

Several years ago most manufacturing companies were getting evaluated to
ISO 9000 standards.  Since that time, there have been some revisions to the
standards.  Does your company still spend time and money dealing with ISO
9000 and it's revisions.  If so, why.  If not, why not?

I realize this subject is not directly related to product safety/EMC, so,
if you like,  you can email me directly with your responses.

All responses are appreciated.

Regards

Joe Martin
EMC/Product Safety Engineer
Applied Biosystems
marti...@appliedbiosystems.com



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ISO 9000:2000 standards

2001-10-10 Thread Andre, Pierre-Marie

Hi colleagues,
I am not sure this subject is part of this forum.
Are the ISO 9000:2000 standards available on line ? I would appreciate at
least some overview.
Looking at
http://www.iso.org/iso/en/iso9000-14000/iso9000/qmp.html#Principle5 give me
some views
but not enough.

thanks for your help

Pierre-Marie Andre
Intel Sophia Senior Approval Engineer
Tel : +33 (0) 4 93 00 14 13   Fax : +33 (0) 4 93 00 14 01
> http://www.intel.com
> 

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