Internal Laboratory Scope - Methods & Standards

J

JR Anderson

#1
The laboratory scope has three requirements as listed in the glossary of QS-9000. The third requirement is: "a list of methods and standards to which it performs the above." (tests). For a general metrology lab that uses primarily CMMs as well as micrometers, an occasional surface plate check , etc, what would satisfy this requirement? Does this mean that I need instructions on how to use each piece of equipment?

[This message has been edited by JR Anderson (edited 31 August 1999).]
 
T

TheOtherMe

#2
I'm going to give you my answer, but it is historical as evidenced in these forums that each registrar has their own interpretation.
"a list of methods and standards to which it performs the above." (tests)
I interpret this to be an index of controlled documents relating to the lab. That list should include lab procedures (a list of methods) and internal specs and documents of external origin (a list of standards). However, UL did not like this approach at one client.

See http://Elsmar.com/ubb/Forum1/HTML/000159.html
Also see http://Elsmar.com/ubb/Forum4/HTML/000074.html
 

Marc

Retired Old Goat
Staff member
Admin
#4
Greg Gogates on 03/10/2000 04:15:02 PM
Subject: Laboratory Scope

Date: Fri, 10 Mar 2000 00:05:58 EST
From: DEPilgrim
To: fasor.com
Subject: Laboratory Scope

Was wondering if anyone could shed light on laboratory scope. I have written some per the Glossary definition in QS-9000, but have not written one for Guide 25 Accreditation. If we go with A2LA, they have forms to fill out that would appear to make up the laboratory scope. Is that all that is needed, or do we need a stand-alone document too!?

Date: Wed, 15 Mar 2000 14:31:40 -0500
From: Steven R Stahley - www.Cummins.com
To: Greg Gogates
Subject: Re: Laboratory Scope

As the chairman of the AIAG Cal Lab Work Group I can not tell you what your QS auditor will want to see as I have seen a very broad range of interpretations for lab scope. I would recommend you try to adopt the ILAC model as closely as it makes sense, refer to the ILAC document on lab scope on their web site www.ilac.org as this will be the direction I believe you will need to go in the future.

Steven Stahley
Manager, Corporate Metrology
Cummins Engine
 

Marc

Retired Old Goat
Staff member
Admin
#5
On a related note:

Date: Tue, 15 Feb 2000 10:32:05 +0100
From: Viggo Munck
To: Greg Gogates
Subject: SV: ISO 17025 Documents and Experts RE8

Dear sirs,

Defining the scope of accreditation is very difficult. The easiest way to do it is to list all the methods and group them. And group the groups. Then the scope natually follows. In Denmark we accredit according to the list of methods, and we do therefore not have any problems in formulating the scopes. The scope can fill up to half a page and not just a few lines. (It must fit in on the accreditation document) Some problems might arise if the accreditation body want you to use fixed wordings and groups. Instead of trying to put things into fixed boxes one should set frames around the real matter. We have been working with flexibility in the scope and I can assure you that this is much more difficult to formulate.

Yours

Viggo Munck
DANAK
Danish Accreditation


-----Oprindelig meddelelse-----
Fra: Greg Gogates
Sendt: 15. februar 2000 00:22
Til: quality.org
Emne: ISO 17025 Documents and Experts RE8


Moderator Note:

I now understand what you are trying to acheive and will keep my eyes open for other related docs and forward them to you.

Maybe you can get some buy-in from http://www.european-accreditation.org/ where I got the prevoisly sent links.

As an assessor , I agree on the need to try and sort out scopes.

Cheers,
Greg

Date: Mon, 14 Feb 2000 15:17:22 -0500
From: "James D. Jenkins"
To: Greg Gogates
Subject: RE: ISO 17025 Documents and Experts RE1

Greg,

Thank you for the links to some existing documents which address requirements of Laboratory Scopes. You can be rest assured that we are not out to re-invent the wheel in this matter. Our objective at NCSL is to review and update our existing document "RP-9". One of our objectives is to review other similar existing documents in order to ensure that we do not provide any "conflicting information" and achieve technical correctness and acceptance of our "Recommended Practice" as a guide consistent with the requirements of accepted International Standards. Although all of the other existing documents I have reviewed thus far,(including those listed below), seem to be somewhat vague in the practical application aspect of the given requirements. In the format of a "Recommended Practice" we intend to provide guidance in this area. As a consultant for Laboratory Accreditation and an Instructor in measurement uncertainty I find a large number of Laboratories have difficulty in formulating their Scope of Laboratory Capability, as this is one of the most frequent areas of which I receive questions and requests for guidance. Being dedicated to the Laboratory Accreditation effort, I wish to assist the NCSL in developing documents which will assist those in the accreditation process and spend my professional time at Quametec assisting, teaching and consulting in areas which require more than a simple instructional explanatory document.

For the International Standardization effort to succeed, it will require accepted standards, consistent interpretations, and guidance where required. Unfortunately, it seems that for a document to be accepted as a standard it must have a certain amount of vagueness to it in order to satisfy the varying interpretations people wish to give it. Case in point, I had heard (RUMOR)that one country was going to vote against ISO17025 unless they could get one more "as applicable" added in an area of concern. It would be nice if the people writing proposed standards would define where these "as applicable"s are applicable. If they could do that, then maybe we wouldn't need all these other interpretive guidance type documents. Which occasionally also give unintended "conflicting information".

NOTE 1: If Lynne Neumann, Jarl Forsten and/or Peter van de Leemput (17025 Drafting Group) read this, let me say that I think your document is an excellent document of which you should all be proud of and I understand the politics of writing standards leaves you little choice in using some undefined "as applicable"s. NOTE 2: "NOTE 1" demonstrates my abilities in politics. Although I sincerely commend them on a job well done.

Keep up the good work Greg, your efforts are commendable and appreciated. I enjoy reading all the threads you relay and recommend your discussion group to all of my customers involved with measurements.

Sincerely,
James D. Jenkins
mailto:Jenkins - quametec.com

> From: owner-iso25 - quality.org On Behalf
> Of Greg Gogates
> Sent: Monday, February 14, 2000 12:21 PM
> To: iso25 - quality.org
> Subject: ISO 17025 Documents and Experts RE1
>
>
> Moderator Note;
> Please incorporate the following EXISTING documents. This community does
> not need more conflicting information.
> Greg
>
> EA-2/05
> The Scope of Accreditation and Consideration of Methods and
> Criteria for the Assessment of the Scope of testing (with
> EUROLAB)
> (previously EAL-P10)
> http://www.european-accreditation.org/pdf/EA-2-05.pdf
>
> And
>
> EA-4/01*
> Requirements Concerning Certificates Issued by Accredited
> Calibration Laboratories (previously EAL-R1)
> http://www.european-accreditation.org/pdf/EA-4-01.pdf
> and
> Appendix C of this document lists suggested EMC scopes of accreditation
> EA-4/13
> Guidance on the Application of EN 45001 and ISO/IEC Guide 25
> to Electromagnetic Compatibility (EMC) Testing (previously
> EAL-G27)
> http://www.european-accreditation.org/pdf/EA-4-13.pdf
>
> Greg
>
> Date: Sat, 12 Feb 2000 11:43:00 -0500
> From: "James D. Jenkins"
> To: Greg Gogates
> Subject: RE: ISO 17025 Documents and Experts
>
> Greg,
> The "Official" ISO/IEC 17025 has recently been made available at
> http://global.ihs.com Global. We at QUAMETEC received our copy from Global
> on 2-Feb-2000. Our people have been applying it to several ISO
> 17025 quality
> systems we have under development for our customers. We began using the
> DIS/ISO17025 format for laboratory quality systems about a year ago and
> adding the additional Guide 25 and A2LA requirements into them where
> relevant. We are also currently updating our Laboratory
> Management Class to
> include the ISO/IEC 17025 requirements.
>
> On a slightly different subject, the NCSL has assigned me the
> task, through
> the "Accreditation Resources Committee", of heading up the effort of
> reviewing and rewriting RP-9, the "Calibration Laboratory Capabilities
> Documentation Guidelines". This document has been referenced by
> A2LA as the
> guide for how laboratories should report their "Scope of Laboratory
> Capabilities". This project is officially under the responsibility of the
> "Accreditation Resources Committee" and committee Chairman Larry
> Neilson of
> Southern California Edison. The document will be expanded to
> include Testing
> Laboratories and provide instructional guidance among other things. I will
> be presenting a paper outlining the draft changes to the document at the
> Toronto NCSL conference in July of 2000. Currently, I am looking for
> comments and ideas pertaining to this subject. I have several myself, but
> wish to use the combined knowledge of as many people as possible
> to produce
> a competent, comprehensive document which will have the makings of an
> International Guide for Testing and Calibration Laboratories. The
> objective
> of the paper to be presented at the NCSL 2000 conference is to
> put forth the
> ideas and supporting logic pertaining to the proposed changes to RP-9 for
> comment. If anyone has any ideas or comments they wish to be
> considered, or
> is aware of any other efforts in the USA or other countries pertaining to
> documents about Laboratory Scope requirements and formats, please email me
> at mailto:jenkins@quametec.com . NOTE: I currently have the ILAC document.
> Anyone wishing to submit comments or ideas, please do so as soon as
> possible. We have set an aggressive schedule in order to get this update
> published in a timely manner.
>
>
> Sincerely,
> James D. Jenkins
> QUAMETEC
> http://www.quametec.com
 

Marc

Retired Old Goat
Staff member
Admin
#6
Date: Tue, 15 Feb 2000 23:37:57 -0000
From: Trevor Thompson
To: Greg Gogates
Subject: RE: ISO 17025 Documents and Experts RE9

UKAS sees the problems exactly the same as DANAK. We are looking at "generic scopes" for laboratories and have made some progress. The idea is that the lab has (and shows us) a decent mechanism for deciding exactly which tests it is competent to undertake, within some agreed technical bounds. I have tried to have schedules agreed between us and the laboratories based a declared "technical bounds" or "parameter based" arrangement ie listing the limits of all the measured parameters involved in the testing for which the lab has demonstarted its equipment, competence, traceability etc.

Not easy.

Trevor Thompson
Accreditation Manager
United Kingdom Accreditation Service
tjt - ukas.com
 

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