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Author Topic:   Laboratory Capability
Marc Smith
Cheech Wizard

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From:West Chester, OH, USA
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posted 08 October 1999 08:43 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Date: Sat, 18 Sep 1999 15:54:25 -0400
From: Philip Stein
To: Greg Gogates
Subject: Re: Laboratory Capabality verification

>Date: Fri, 10 Sep 1999 17:07:11 -0400
>From: Etienne Godbout
>To: iso25@fasor.com
>Subject: Laboratory Capabality verification
>
>Can someone explain to me, or where could I find the method or
>informations on how to verifiy Laboratory Capability, based on the QS-9000
>third edition requirement.

Well, there is no one way. This is a non-prescriptive requirement and it's up to you to decide how to do it.

One way is to become Guide 25 accredited (see A2LA, NVLAP, SCC, etc.) Another is to set things up according to the requirements of Guide 25 without actually becoming accredited.

Another way is to use measurement assurance, with control charts and check standards (see, for example, PMAP software by JTI Systems, courses from me or from Coast Metrology Systems, etc.)

Yet another way is to join a proficiency test program or to set one up. See ISO Guide 43, ASTM E-1301, or www.proficiency.org. Philip Stein O- Consultants in the Physical Sciences, Measurements, and Quality Fellow, American Society for Quality, and Member of its Board of Directors Past Chair, ASQ Measurement Quality Division, A2LA Assessor Check out http://www.metrology.org, http://www.hamvention.org and of course, http://www.measurement.com

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Theron Taylor
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From:Independence, KS USA
Registered: Jan 99

posted 13 October 1999 03:00 PM     Click Here to See the Profile for Theron Taylor   Click Here to Email Theron Taylor     Edit/Delete Message   Reply w/Quote
With regard to ISO/IEC Guide 25, I have a question? In QS9000 under 4.11.2 on page 44, in the middle of the page is a paragraph that I do not understand at all. Can you explain the last half of the paragraph where it states;, - - - - - - - "assessment by an OEM customer or an OEM customer-approved second party, that they meet the intent of ISO/IEC Guide 25 or national equivlent." I do not know who the Big Three are refering to here when they say OEM customer or OEM customer-approved second party.

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Brad Lee
Lurker (<10 Posts)

Posts: 3
From:Singapore
Registered: Sep 1999

posted 14 October 1999 07:38 AM     Click Here to See the Profile for Brad Lee     Edit/Delete Message   Reply w/Quote
What is a definition of a "Laboratory" anyway?
Does it require some proper set-up?
Can one declares that his company does not have a "lab" but there is some facility to measure, test, and calibrate?

-Brad

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Marc Smith
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posted 15 October 1999 08:42 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
A lab is pretty much anywhere inspection and/or testing is done except on line. QS 9 defines a laboratory as "...a test facility that may include chemical,...or test validation." As I'm sure you see, they don't refer to calibration, although as I understand it your calibration lab is part of the show...

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admin
Cheech Wizard

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Registered: Feb 99

posted 15 October 1999 04:55 PM     Click Here to See the Profile for admin     Edit/Delete Message   Reply w/Quote
quote:
QS9000 under 4.11.2 on page 44 - Can you explain the last half of the paragraph where it states: "assessment by an OEM customer or an OEM customer-approved second party, that they meet the intent of ISO/IEC Guide 25 or national equivlent."
4.11.2.b.1 Well, an audit by Ford, GM or Chrysler or some company they approve. They may have a list - anyone have any specifics on this?

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Theron Taylor
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From:Independence, KS USA
Registered: Jan 99

posted 18 October 1999 01:13 PM     Click Here to See the Profile for Theron Taylor   Click Here to Email Theron Taylor     Edit/Delete Message   Reply w/Quote
Marc, is the OEM customer in the reference section, the OEM themselves? If so, and we are doing business with GM, they would be the OEM customer, spoken of in this section. Could the second party be a QS9000 registar or does it have to be someone different than your registar?
Our registar's representative auditor said they were not qualified to determine if we met the intent of Guide 25 and did not know how we, or any lab, could prove they meet this requirement on intent alone. In other words he was saying A2LA, NAVLAP or other qualified source would have to do a registration audit to Guide 25, and grace us or the supplier lab with a Certificate.

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Sam
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Registered: Sep 1999

posted 18 October 1999 02:03 PM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
Ref. Theron Taylor; our auditor made the same comments to us concerning guide 25.

My question is "who is the national equivalent "to guide 25?

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Marc Smith
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posted 18 October 1999 06:25 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
Marc, is the OEM customer in the reference section, the OEM themselves?
OEM = Ford, Chrysler or GM as I understand it (see below).
quote:
If so, and we are doing business with GM, they would be the OEM customer, spoken of in this section.
Yes, as I understand it.
quote:
Could the second party be a QS9000 registar or does it have to be someone different than your registar?
The verbiage sucks, but as I understand it, the second party may or may not be your or any other registrar. A small registrar. They have gotten together with GM and GM has approved them to audit labs to Guide 25. This has recently taken place. There is still a snag, however. They are trying to decide whether a small registrar will be 'certifying' the lab or whether a simple letter will be given by the registrar to the lab audited (what is YOUR definition of 'certifying'?). If you go to a lab and they say they were audited by a small registrar and your OEM is GM you're in gear - you can use the lab because the small registrar audited them.

The verbiage sucks, as I say, in my opinion, because it says "...by an OEM customer..." I understand OEM to be Ford, Chrysler and / or GM, and their customers are every-day folks thru dealerships. I admit it - I'm confused as well. Maybe someone who has gone thru the QS9000 Registrar Auditor course can respond to this.

quote:
My question is "who is the national equivalent "to guide 25?
If you live in Brazil and Brazil doesn't recognize Guide 25 (in reality I have no idea whether Brazil actually does or does not), they will probably have a Brazilian 'national' equivalent.

[This message has been edited by Marc Smith (edited 18 October 1999).]

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barb butrym
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posted 19 October 1999 08:40 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
In reality, QS (AIAG) has agreed that a lab, registered to ISO 9002, including guide 25 in its system....meets the requirements.

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Steph
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From:Concord, Ontario, Canada
Registered: Mar 99

posted 19 October 1999 10:00 AM     Click Here to See the Profile for Steph   Click Here to Email Steph     Edit/Delete Message   Reply w/Quote
Sam

I'm not sure what the equivalents are in other countries, but in Canada the Standards Council has PALCAN, which is accepted by ISO as the same as Guide 25. I think most countries have there own version that is the equivalent to Guide 25.

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Theron Taylor
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From:Independence, KS USA
Registered: Jan 99

posted 21 October 1999 03:23 PM     Click Here to See the Profile for Theron Taylor   Click Here to Email Theron Taylor     Edit/Delete Message   Reply w/Quote
Barb, can you explain your statement in more detail. I am not sure I understand what you are really saying. Including Guide 25 in your QS or ISO registration?

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barb butrym
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posted 22 October 1999 08:11 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
If you add the details from guide 25 to your system, as your own requirements, then the registrar must audit to them, and that satisfies the requirement...by formal agreement.

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dewie
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From:BKK
Registered: Sep 1999

posted 23 October 1999 01:52 PM     Click Here to See the Profile for dewie   Click Here to Email dewie     Edit/Delete Message   Reply w/Quote
barb butrym
Please give me more describe. As I know Registrar who can assess ISO/IEC Guide 25 need to be accreditation body. Is case that the registrar who audit ISO or QS 9000 audit the lab against Guide 25, how they can say that this lab is complied to guide 25.

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barb butrym
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posted 25 October 1999 10:03 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
I am not sure what you were asking.....sorry. I do contract 2nd party guide 25 audits for a major manufacturer as well....not sure what your point is?

Are you saying that an ISO/QS9000 lead assessor cannot audit the requirements of a standard/published guide 25 (or any other for that matter?)...I am saying the AIAG etal. have agreed that they will accept the results of an ISO9002 registration audit of a lab, operating to a system whose scope includes the requirements of guide 25. Guide 25 is clear in its requirements....very audit friendly, and runs the same line ISO9002 does. As the client, I would look for experience in my industry...any industry....before chosing a registrar/auditor.

[This message has been edited by barb butrym (edited 25 October 1999).]

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