Laboratory Capabality Verification based upon QS-9000 Third Edition

[Marc]

Date: Sat, 18 Sep 1999 15:54:25 -0400
Subject: Re: Laboratory Capabality verification

>Date: Fri, 10 Sep 1999 17:07:11 -0400
>From: Etienne Godbout
>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

Check out http://www.hamvention.org and of course, http://www.measurement.com

 

[Theron Taylor]

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.

 

[Brad Lee]

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

 

[Marc]

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...

 

[Forum Administrator]

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?

 

[Theron Taylor]

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.

 

[Sam]

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?

 

[Marc]

Marc, is the OEM customer in the reference section, the OEM themselves?

OEM = Ford, Chrysler or GM as I understand it (see below).

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.

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. Example: Eagle Registrations is a small registrar in Dayton, Ohio. 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 Eagle will be 'certifying' the lab or whether a simple letter will be given by Eagle to the lab audited (what is YOUR definition of 'certifying'?). If you go to a lab and they say they were audited by Eagle Registrations and your OEM is GM you're in gear - you can use the lab because Eagle 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.

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).]

 

[barb butrym]

In reality, QS (AIAG) has agreed that a lab, registered to ISO 9002, including guide 25 in its system....meets the requirements.

 

[Steph]

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.