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September 2009 Newsletter

A2LA has launched a newly designed website. The new design incorporates feedback received over the past several years to make the site more user-friendly. All existing information and documents are still available but organized in a more intuitive layout to streamline searching and accessing content. Users are invited to provide any additional comments on the new design. A2LA also announces adopting a new scope and certificate format.

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Panneer Selvam
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
72 views12 pages

September 2009 Newsletter

A2LA has launched a newly designed website. The new design incorporates feedback received over the past several years to make the site more user-friendly. All existing information and documents are still available but organized in a more intuitive layout to streamline searching and accessing content. Users are invited to provide any additional comments on the new design. A2LA also announces adopting a new scope and certificate format.

Uploaded by

Panneer Selvam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 12

A2LA Launches

New Website
General Updates, Notices &
Press Releases:
A2LA Launches New Website

A2LA Adopts New Scope & Certificate

Format
Fall Training Schedule

Recent Promotions
Change in Terminology of the Best

Measurement Capability (BMC) for
Accredited Calibration Laboratories
Updates on A2LA
Operations & Policies:
New & Updated Documents

Use of the NIST Website for Timer

Calibration
New Applications of ISO/IEC 17025

Requirements
What is an Acceptable Standard Method

for Surface Plate Calibration?
Meeting Summaries:
Veterinary Program Update
AACC Annual Meeting

2009 NCSL International Conference
International Activities:
A2LA Well Represented in Producing
the New International Standard for
Proficiency Testing
A2LA is proud to launch our newly designed website! The new design
takes into consideration comments, suggestions and criticisms from all of the sites us-
ers over the past several years. The changes made are intended to make the site more
Editor: Teresa Barnett

user-friendly, such that information is more readily at hand and easily retrievable. All
of the same information, documents, publications and announcements are contained  Layout Design: Gina McInturff
on the new website but in a more intuitive layout that should make your search and
retrieval processes more streamlined.
If you have any comments or questions concerning our new website design, please
contact us at [email protected] or 301 644 3248.
General Updates, Notices & Press Releases

A2LA Adopts New Scope &


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This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General Requirements Defortermi Eleme ratory 00
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and Scopes will be uploaded to the A2LA website in _______________________


President & CEO
For the Accreditation Council

print-ready quality and all Certificates and Scopes that


Certificate Number 3999.01
Valid to 31 July 2011

are updated, issued or re-issued on or after July 20, For the tests or types of tests to which this accreditation applies, please refer to the laboratorys Chemical Scope of Accreditation.
Page 1
of 3

2009 will appear in the new format.


Please be sure to alert your customers and end users of the new look to your accreditation documents so there is no
confusion in the marketplace.
If you have any questions, please contact your Accreditation Services staff person directly or A2LA at 301 644 3248.

Course: Venues:
September 27-October 2, 2009
Title: Introduction to Measurement
Uncertainty The Westin Indianapolis
50 South Capitol Avenue
October 1-2, 2009-Indianapolis, IN
Indianapolis, IN 46204
($795.00 non-members, $745.00 members)
(800) 228 3000
November 16-17, 2009-Charleston, SC Rate: $159.00 Per Night
($795.00 non-members, $745.00 members)
October 18-23, 2009
Title: ISO/IEC 17025 and Accreditation Sheraton Fishermans Wharf
September 28-30, 2009-Indianapolis, IN 2500 Mason Street
($995.00 non-members, $945.00 members) San Francisco, CA 94133
November 18-20, 2009-Charleston, SC
 (888) 627 7024
($995.00 non-members, $945.00 members) Rate: $165.00 Per Night
November 15-20, 2009
Title:  ssessment of Laboratory
A The Mills House Hotel
Competence 115 Meeting Street
October 19-23, 2009-San Francisco, CA Charleston, SC 29401
($1595.00 non-members, $1545.00 members) (843) 577 2400

 or additional course information, please contact Julie Stevens, A2LA Training Coordinator, at 301 644 3235 or
F
[email protected].

2
General Updates, Notices & Press Releases

Recent Promotions
of A2LA Staff
So far in 2009, several reorganizations have occurred within A2LAs Accreditation Services department both to recognize advanced
levels of achievement and to maintain an efficiently managed system.
Please join us in congratulating the following staff members who have been promoted within Accreditation Services:
Pam Wright has been appointed an Accreditation Manager in the Calibration area.
Rob Miller has been appointed an Accreditation Manager in the ElectroMechanical area.
Roger Brauninger has been promoted to the level of Program Manager in the area of Biosafety testing.
Adam Gouker has been promoted to the level of Program Manager in the area of EMC testing.
Mike Hart has been promoted to the level of Program Manager in the area of Construction Materials testing.
Beth Carbonella has achieved the level of Senior Accreditation Officer within the Materials/Physical testing group.
The organizational structure of A2LAs Accreditation Services department can be viewed below or via A115a Accreditation Services
Structure Chart which is available on the A2LA website.

Operations Manager
Trace McInturff 223

Accreditation Manager Accreditation Manager Accreditation Manager Accreditation Manager


Life Sciences Materials/Physical Calibration ElectroMechanical
Randy Querry 221 Steve Medellin 228 Pam Wright 201 Rob Miller 239

Program Manager Program Managers Program Managers Program Managers


ISO 15189 ILAC G13 / ISO Guide 43 ISO/IEC 17020 ISO Guide 65
Roxanne Robinson 208 Randy Querry 221 Steve Medellin 228 Rob Miller 239
(acting) ISO Guide 34 Construction Materials EMC
Accreditation Officer Randy Querry 221 Mike Hart 237 Adam Gouker 217
Ray Minnick 215 Biosafety Sr. Accreditation Officers Accreditation Officers Accreditation Officers
Accreditation Associate Roger Brauninger 233 Beth Carbonella 219 Elizabeth Smith 207 Matthew Torres 225
Lauren Moore 231 Accreditation Officers Accreditation Officers Vincent Pugh 232 Diana Gavin 234
Atefeh Fathi 210 Sara Weitzel 224 Robert Knake 218 Kimberly Watson 482
Brian Conner 216 Aruna Kaveeshwar 226 Jason Poore 205 Accreditation Associate
Ray Minnick 215 Karin Athanas 236 Ashly Bowers 238 Office Coordinator
Liz Shanklin-Selby 220 Accreditation Associate Accreditation Associate Karen Rudd 206
Chris Gunning 481 Office Coordinator Training / Membership
Accreditation Associate Karen Rudd 206 Coordinator
Lauren Moore 231 Julie Stevens 235

3
General Updates, Notices & Press Releases

Change in Terminology of the Best Measurement


Capability (BMC) for Accredited Calibration
Laboratories
Metrological traceability is being disseminated to the market by will be changed to CMC (see ILAC 2009-08-20 BMC to CMC
A2LA (an International Laboratory Accreditation Cooperation Circular). The intention is to achieve world-wide harmonization
(ILAC) MRA signatory) accredited calibration laboratories and by of terminology in the dissemination of metrological traceability.
National Metrology Institutes (NMIs) under the CIPM MRA. This A2LA has always required its accredited laboratories to publish
traceability provides reliability in measurements around the world. its CMC on their Calibration Scope of Accreditation; however, it
Currently, the services provided by accredited calibration labo- was termed Best Uncertainty. In an effort to remain consis-
ratories are described by the term Best Measurement Capabil- tent with ILAC and its arrangement signatories, effective immedi-
ity (BMC) which expresses the lowest uncertainty that can be ately, A2LA will begin transitioning our laboratories to the CMC
achieved during a calibration. This terminology is widespread in terminology through our regular annual review and renewal of
accreditation around the world. accreditation process; with the expectation that we will com-
NMIs have a similar description of the services provided to their plete this transition by September 2010. During this transition
customers; however, the term is Calibration and Measurement period, references on A2LA scopes of accreditation may specify
Capability (CMC). the BMC as well as the CMC terminology. As a consequence of
the CIPM-ILAC Common Statement and the ILAC Circular (dat-
The Bureau International des Poids et Mesures (BIPM) and the ed August 20, 2009) the BMC and the CMC shall be considered
Regional Metrology Organisations (RMOs) have, in cooperation equal by laboratories, their customers, the market and regulators.
with the ILAC and Regional Accreditation Bodies (RABs), inves-
tigated the difference in terminology and have arrived at the fol- If you have any questions or concerns, please contact your
lowing conclusion: accreditation officer.

In the context of the CIPM


MRA and ILAC Arrangement,
and in relation to the CIPM-
ILAC Common Statement, the CIRCULAR TO ALL ILAC MEMBERS
following shared definition is
agreed upon:
ACTION REQUIRED BY ILAC MEMBERS
CMC is a calibration and measure- ON ILAC GENERAL ASSEMBLY RESOLUTIONS
ment capability available to cus-
tomers under normal conditions:
TOPIC: Change in Terminology Relating to Best Measurement Capability (BMC)
(a) as published in the BIPM key and Calibration Measurement Capability (CMC)
comparison database (KCDB) of
the CIPM MRA; or DATE: 20 August 2009
(b) as described in the laboratorys
The ILAC General Assembly in Sydney 2007 and in Stockholm 2008, made the
scope of accreditation granted by following resolutions:
a signatory to the ILAC Arrange-
ment. ILAC Resolution GA 12.23
ILAC reaffirms its commitment to the agreement (ILAC resolution GA 11.20) between ILAC and
ILAC has decided to make a BIPM by implementing a terminology change from BMC to CMC as soon as practicable.
shift of terminology and in the The General Assembly notes that other issues have been identified during the development of
this agreement and these will be addressed in the new measurement uncertainty document
future all references to BMC currently under preparation.

It is important that action on the above resolution is taken as soon as possible. This will be
addressed under the section of this agenda associated with Working Group 2.
Continued on page 5
ILAC Resolution GA 11.20
The ILAC General Assembly accepts the ILAC/BIPM joint paper on Calibration & Measurement
Capabilities (CMC) as a significant step forward in the coordination of this concept between
4 ILAC and BIPM.
DATE: 20 August 2009

The ILAC General Assembly in Sydney 2007 and in Stockholm 2008, made the
following resolutions: General Updates, Notices & Press Releases
ILAC Resolution GA 12.23
ILAC reaffirms its commitment to the agreement (ILAC resolution GA 11.20) between ILAC and
BIPM by implementing a terminology change from BMC to CMC as soon as practicable.
The General Assembly notes that other issues have been identified during the development of
this agreement and these will be addressed in the new measurement uncertainty document
currently under preparation.

It is important that action on the above resolution is taken as soon as possible. This will be
addressed under the section of this agenda associated with Working Group 2.

ILAC Resolution GA 11.20


The ILAC General Assembly accepts the ILAC/BIPM joint paper on Calibration & Measurement
Capabilities (CMC) as a significant step forward in the coordination of this concept between
ILAC and BIPM.

ILAC will take this joint paper into account when preparing future documents on measurement
uncertainty, in collaboration with the BIPM.

These resolutions were the result of extensive liaison and agreement by ILAC and
BIPM, that a change in terminology from BMC (Best Measurement Capability) to
CMC (Calibration Measurement Capability) was appropriate and desirable.

The background to these discussions may be found on the ILAC website under
Publications and Resources, by scrolling down to Calibration and Measurement
Capabilities (CMC) and clicking on CMC in the last sentence. The paper is entitled
Calibration and Measurement Capabilities A Paper by the Joint BIPM/ILAC
working group.

The following points are to be noted.

1. References to BMC in scopes of accreditation for calibration facilities should


be amended to read CMC. This change is considered to be a terminology
change only, as BMC and CMC have been agreed to be equivalent.

2. The timeframe for the terminology change has been set at two years from the
date of this circular.

The means whereby this change should be made has not been defined but
ILAC Members are invited to review the scopes of accreditation of calibration
facilities during the next relevant scheduled visit and make the relevant change
in terminology from BMC to CMC. This should be undertaken in line with a
review of the CMCs of the NMI which provides the calibration laboratory with its
metrological traceability. (The CMCs of NMIs can be found on the CIPM-
database.)
2009-08-20_BMC to CMC Circular
3. Progress by ABs in implementing this terminology change will be reviewed Pageat
1 of 2
the next evaluation of the AB that occurs two years from the date of this circular.

4. It is recognised that further work is required by ILAC and BIPM to clarify and
harmonise matters around CMC. This work is ongoing and further relevant
information will be provided at an appropriate time.

5. The intention of this terminology harmonisation is to improve the dissemination


of metrological traceability. The adoption of the same terminology in relation to
accredited calibration facilities and NMIs will greatly assist in this process and
provide clarity in the market place.

The ILAC Marketing and Communications Committee has also been asked to
prepare suitable material for ABs to distribute that defines the benefits of this
terminology change for end users.

5
Updates on A2LA Operations & Policies

Traceability and Use of the


NIST Website for Timer &
The following documents have been updated
Stopwatch Calibrations
within the controlled A2LA management sys- By Rob Knake, A2LA Accreditation Officer
tem. All of these documents are available on
the A2LA website (www.A2LA.org) through If your organization offers calibrations for timers & stopwatches
the Document Finder option unless other- and uses the Official U.S. Time Clock reference standard (avail-
wise indicated. able through the National Institute for Standards and Technologies
P106 Branch System Policy was updated on (NIST) website at http://nist.time.gov) to conduct a Direct Com-
June 11, 2009. (Document Finder category: Policies) parison for calibration, problems arise when it comes to establishing
R212 Specific Requirements: Nondestructive traceability.
Testing Laboratory Accreditation Program was up- More than likely your organization is using a personal computer
dated on June 11, 2009. (Document Finder category: with a web browser to utilize this resource. However, there is a se-
Specific Requirements) rious flaw in this approach as your computers clock will actually
R307 General Requirements: Accreditation supersede the time displayed on the website when your web browser
of ISO/IEC Guide 65 Product Certification Bodies is left open. In essence, once you have opened the website on your
was updated on August 7, 2009. (Document Finder internet browser the time being displayed is actually the time being
category: General Requirements) kept by your computers own internal clock. It is true that many web
browsers will automatically refresh at pre-set time intervals, 5, 10, or
R301 General Requirements: Accreditation
15 minutes for example, but during the time in between refreshes,
of ISO/IEC 17020 Inspection Bodies was updated
the time displayed is not actually coming directly from NIST but
on August 7, 2009. (Document Finder category: Gen-
rather from your own personal computer. As such, you no longer
eral Requirements)
have an established traceability chain.
P101 Reference to A2LA Accredited Status-
Please note that NIST does provide traceable reference standards for
A2LA Advertising Policy was updated on August 7,
timer & stopwatch calibrations in other formats (telephone & radio
2009 (Document Finder category: Policies), as was
signal) that are available to the public and maintain the traceabil-
the associated assessor checklist, C104 - General
ity chain. For more information regarding acceptable methods and
Checklist: Reference to A2LA Accredited Status-
acceptable traceable reference standards please refer to NIST Rec-
A2LA Advertising Policy (Document Finder category:
ommended Practice Guide 960-12 Stopwatch and Timer Calibra-
General Checklists).
tions, which is available at http://tf.nist.gov/general/pdf/2281.pdf.
R104 General Requirements: Accreditation
As tempting as it may be, the
of Field Testing and Field Calibration Laboratories
time clock provided by the
was updated on August 6, 2009 (Document Finder cat-
NIST website should not
egory: General Requirements) and the associated
be used as your labora-
checklist, C103 General Checklist: Accreditation
torys reference stan-
of Field Testing and Field Calibration Laboratories
dard as traceabil-
(Document Finder category: General Checklists),
ity is not established
was similarly updated on August 7, 2009.
and your laboratory
F117 Technical Staff Matrix for Accredita- would not be meet-
tion: ISO/IEC 17025 was updated on August 12, 2009 ing the requirements
(Document Finder category: Application Forms). of ISO/IEC 17025:2005
If you have any questions about these updates, please or P102 A2LA Policy on
contact A2LA at 301 644 3248 or your Accreditation Measurement Traceability.
Officer directly.

6
Updates on A2LA Operations & Policies

New Applications of
ISO/IEC 17025 Requirements
In August 2009, the A2LA Criteria Council voted to approve four new applications of the ISO/IEC 17025:2005
requirements. These and other explanations may be found on the A2LA website section, Understanding ISO/
IEC 17025.

1 Is the master list my lab created to meet Section 4.3.2.1


of the Standard considered a record or is it considered a
document that would be subject to document control require-
3 My laboratory is part of a multi-laboratory organization.
All laboratories within my organization are A2LA accred-
ited and fall under the classification of a branch system as de-
ments? fined by A2LA. If my laboratory receives work from a client but
RESPONSE: A2LA considers a laboratorys master list to be a sends the work to another of our accredited branch laborato-
record and not a document that is subject to document control ries (with the final report being issued by my laboratory), is this
requirements. Section 4.3.2.1 of ISO/IEC 17025 indicates that considered sub-contracting per Section 4.5 of the Standard?
the clause can be met by use of either a master list (subject RESPONSE: As stated in Part C, Section I of R101 General
to requirements associated with record management) OR an Requirements: Accreditation of ISO/IEC 17025 Laboratories,
equivalent document control procedure (subject to document A2LA accreditation is site specific, meaning that each discrete
control requirements). location is considered to be its own entity whether or not it

2
is part of a larger, accredited, multi-laboratory organization. As
Per Section 5.9.1 of the Standard, what sort of quality con- such, transfer of work among accredited locations within such
trol practices can my laboratory implement for destruc- a branch system is considered to be sub-contracting and is
tive and/or pass/fail types of tests in which no equipment is subject to all requirements related to sub-contracting in ISO/
used? IEC 17025 and related A2LA requirements documents.

4
RESPONSE: Section 5.9.1 requires each laboratory to have
quality control procedures for monitoring the validity of tests Do Sections 4.1.5 (b) and (d) of the Standard require our
or calibrations undertaken. This clause also lists possible ways laboratory to have a Code of Ethics in place?
in which this monitoring may occur, but it is clearly stated that RESPONSE: ISO/IEC 17025 does not explicitly require that a
the items in the list are not mandatory (This monitoring laboratory have a Code of Conduct or Code of Ethics in place
may include) and that the list is not intended to be com- as part of its management system. That said, however, each ac-
prehensive (may include, but not be limited to). As such, credited organization is strongly encouraged to have such mea-
for tests or calibrations for which the items listed in 5.9.1 are sures in place to aid in fully complying with these sections of the
not practical or possible, other means for monitoring quality Standard and to aid in substantiating the ethical grounds upon
control may be employed such as observation of technicians which an organization operates if their actions are ever called
and technique during routine training, performance evaluations, into question.
internal audits, etc. The laboratory is not required to have a A helpful tool to assist any organization in developing and main-
single procedure to meet the requirements of Section 5.9.1 and taining a Code of Conduct or Code of Ethics is an ethics self-
so if other forms of monitoring quality control are employed, assessment. Such a self-assessment can help an organization
these may certainly be described in other procedures within identify those areas where they are on strong ethical ground
the management system, such as training procedures, internal as well as areas that they may wish to examine further as an
audit procedures, etc. The outcome of all monitoring activities, opportunity to enhance or further define their ethical and
however, must be recorded and reviewed in compliance with leadership practices. Some points to consider in an ethics self-
Section 5.9.1. assessment might include:
Continued on page 8

7
Updates on A2LA Operations & Policies
Continued from page 7

Do you strive to be a role model for ethical behavior? Do you maintain confidences entrusted to you?
A
re your statements and actions consistent with profession- D
o you demonstrate through personal action and organi-
al ethical standards? zational policies zero tolerance for any form of staff harass-
A
re your statements and actions honest even when ment?
circumstances would allow you to confuse the issues? D
o you expect and hold staff accountable for adherence to
D
o you advocate ethical decision making by your organiza- your organizations ethical standards (for example, through
tions Board, management team and staff? periodic performance reviews)?

Do you use an ethical approach to conflict resolution? D


o you hold all staff and business partners accountable for
compliance with professional standards, including ethical be-
D
o you initiate and encourage discussion on the ethical havior?
aspects of your organizations management issues?
A
re you mindful of the importance of avoiding even the ap-
D
o you use your authority solely to fulfill your responsibili- pearance of wrongdoing, conflict of interest or interference
ties and not for self-interest or to further the interests of with free competition?
family, friends or associates?
D
o your organizations structure and processes ensure the
W
 hen an ethical conflict confronts you or your organiza- integrity of its activities?
tion, are you successful in finding an effective resolution and
ensuring it is followed? D
oes your organization present itself accurately and hon-
estly to the public?
D
o you demonstrate your organizations vision, mission and
value statements in your actions? D
o you understand and abide by local, state and federal laws
and regulations applicable to you?
D
o you have a routine system in place for members of your
organization to make full disclosure and reveal potential con- (Information drawn from The Joint Commission on Accredi-
flicts of interest? tation of Healthcare Organizations, The American College of
Healthcare Executives and the Higher Learning Commission.)

What is an Acceptable Standard Method for


Surface Plate Flatness Calibration?
By Robert Knake, A2LA Accreditation Officer
A very important part of the calibration process is determining which method your laboratory will use to perform the calibration. For
many calibrations the choice is usually fairly simple and straightforward. The reason for this is that there is often a standard method avail-
able that is widely accepted throughout the industry. These methods are often published in international, regional, or national standards
and are easy to access for use. However, there are times when determining a standard method for a specific calibration is not clear or
straightforward.
Concern was raised in the A2LA Measurement Advisory Committee (MAC) about the confusion that exists among A2LA accredited
organizations regarding an acceptable standard method for the calibration of Surface Plate Flatness. It was determined at the MAC meet-
ing held during the A2LA 2009 Conclave that the method described in the article titled How to Calibrate Surface Plates in the Plant
published in the October 1955 edition of The Tool Engineer is considered an acceptable standard method for the calibration of Surface
Plate Flatness. This method is also commonly referred to as the Moody Method as it was written by Mr. J. C. Moody.
For those laboratories performing calibrations for Surface Plate Flatness as described in the Moody Method, A2LA considers you to be
using a standard method that does not require validation. If your laboratory chooses to use another method for the calibration of Surface
Plate Flatness, your method may be subject to validation per ISO/IEC Section 5.4.5.
For further information please contact Robert Knake at 301 644 3218 or [email protected].

8
Meeting Summaries

Veterinary Program American Association


for Clinical Chemistry/
Update Clinical Laboratory
By Matthew Torres, A2LA Accreditation Officer

In February 2009, the first internationally-recognized accreditation to the


Expo (AACC)
revised A2LA Veterinary Laboratory Accreditation Program requirements
was granted to the National Veterinary Services Laboratories in Ames, IA
Annual Meeting
and the National Veterinary Services Foreign Animal Disease Diagnostic
Laboratory in Plum Island, NY. The Veterinary Laboratory Accreditation
Trace McInturff, Operations Manager, and Randy
Program requirements were revised to include the OIE Quality Standard
Querry, Accreditation Manager-Life Sciences, rep-
and Guidelines for Veterinary Laboratories: Infectious Diseases, 2008, which
differ from ISO/IEC 17025. Dr. Peter Wright, an Expert Participant on
resented A2LA at the 2009 AACC Annual Meet-
the OIE Biological Standards Commission since 1991, states, We are hear- ing in Chicago, IL from July 19 23. AACC is an
ing more and more credit being given to quality management systems like international medical society of clinical laboratory
ISO 17025, and veterinary laboratories around the world are picking up on professionals, physicians, research scientists and
that. Both the quality management system and method validation prin- other individuals involved with clinical chemistry
ciples must be present together. and related disciplines.
The National Veterinary Services Laboratories (NVSL) provides a wide A2LA attended the US Technical Advisory Group
variety of services and information for both domestic and international for ISO/TC 212 meeting held in conjunction with
purposes centered on diagnosis of domestic and foreign animal diseases, the AACC annual meeting.Topics of discussion in-
support of disease control and eradication programs, reagents for diagnos- cluded the ongoing revisions to ISO 15189 and
tic testing, and training. This accreditation program incorporates specific the current progress on revising several other
requirements with respect to unique aspects of veterinary laboratories while ISO technical standards. The next US TAG ISO/
maintaining standard requirements of ISO/IEC 17025 accreditation. Dr.
TC212 meeting will be held during the CLSI Lead-
Elizabeth Lautner, NVSL Director, says, The NVSL is pleased to achieve
ership Conference scheduled for March 22 26,
accreditation to the new requirements. This is a significant milestone in our
continued enhancements of our quality management system to better meet 2010 in Baltimore, Maryland.
the needs of our customers, stakeholders, and the public. A2LA exhibited at the AACC Clinical Lab Expo
The NVSL has recently to promote A2LA accreditation and the ILAC Ar-
added a new, major facil- rangement.The Clinical Lab Expo is said to be the
ity to their expansive Iowa largest clinical laboratory tradeshow in the world,
campus: The new Na- hosting some 600 exhibiting organizations. A2LA
tional Centers for Animal fielded many questions from attendees regarding
Health laboratory facil- A2LAs history and background, the A2LA assess-
ity, which opened in July ment and accreditation processes and costs, ISO
2009. Functions of the National Veterinary Services Laboratories are lo- 15189:2007 standard applications, the ILAC Ar-
cated in this new facility along with the National Animal Disease Center rangement, and other accreditation services of-
and the Center for Veterinary Biologics. fered by A2LA, such as reference material produc-
er and proficiency testing provider accreditation.
In March 2009, A2LA initiated a new veterinary training course for those We were pleased with the interest in our pro-
laboratories seeking to understand ISO/IEC 17025:2005 and the new Vet- grams and look forward to attending future clini-
erinary Laboratory Accreditation Program requirements. Daren Valentine, cal conferences.
A2LA Communications Manager, and Matthew Torres, A2LA Accredi-
tation Officer, conducted the pilot veterinary training course for several
state, university, and industry veterinary laboratories at the Maryland De-
Continued on page 10

9
Meeting Summaries
Continued from page 9

partment of Agriculture College Park Animal Health Diagnostic


Laboratory in College Park, MD. Peter Unger, A2LA President & A2LA Accreditation Officer, Matthew Torres, also attended the
CEO states, These new training classes show A2LAs commitment ACVIM (American College of Veterinary Internal Medicine) con-
to teaching veterinary laboratories about ISO/IEC17025 by far ference in Montral, Qubec, Canada from June 2, 2009 to June 6,
the most popular standard for accrediting veterinary laboratories 2009. This venue was an international educational venture hosted
throughout the world. The standard is so valuable because of its by an American veterinary specialty group. The CVMA (Canadian
flexibility to give power back to the laboratories where it belongs. Veterinary Medical Association) also had a large presence and role in
This makes ISO/IEC 17025 what the most cutting-edge labs are organizing this meeting which was beneficial to all attendees. The
using today. This class is ideal for those seeking to understand overall focus of the meeting, similar to the NAVC (North Ameri-
17025 and the role of quality managers in a veterinary testing set- can Veterinary Conference) and WVC (Western Veterinary Con-
ting. Essentially, ISO/IEC 17025 explains the duties of the quality ference) was continuing education for veterinarians with a clinical,
manager and an understanding of the interpretation of ISO/IEC practice-oriented theme. The meeting differed, however, in that the
17025 will provide veterinary quality managers with the confidence ACVIM, like the American Society of Veterinary Clinical Patholo-
they need to fulfill their duties. Dr. Thomas Jacobs, Assistant State gists (ASVCP), also has a focus on board certification in addition to
Veterinarian of Maryland says, The ISO 17025/OIE Standards continuing education. Many attendees expressed interest in ISO/
were clearly explained by experienced instructors. The handouts, IEC 17025 accreditation in general and veterinary laboratory ac-
power-point and blackboard presentations were clear and precise. creditation specifically.
Overall the training allowed us to begin the accreditation process
with confidence. In addition to training on ISO/IEC 17025 and The high quality of the talks presented at the ACVIM conference
A2LAs R216 (Veterinary Laboratory Accreditation Program Re- made this one of the best venues for broad veterinary continuing
quirements), select state participants also shared interest in A2LAs education because it is a meeting of internists with diverse special-
ISO 15189 Medical Accreditation Program. Interested parties may ty groups represented. Many talks were offered on the subjects of
refer to the completely refreshed A2LA webpage which has promi- ACVIM consensus statements, infectious diseases, neurology, gas-
nent tabs dedicated to Veterinary Medical Testing and (Human) troenterology, and food animal health. The outcome of this years
Medical Testing. ACVIM consensus statements was communicated effectively by
the United States Animal Health Association (USAHA) newsletter
published daily.

2009 NCSL International Conference


This years NCSLI conference was held at the San Antonio Convention Center in
San Antonio,Texas during the last week of July. The theme for this years conven-
tion was Metrologys Impact on Global Trade. A2LA was represented by Rox-
anne Robinson, A2LA Vice President/COO, Pamela Wright, A2LA Accreditation
Manager, and Rob Knake, A2LA Accreditation Officer. In keeping with this years
theme, Ms. Robinson presented Metrology & Accreditation Their Role in the
Global Market at one of many informative technical sessions that were offered
during the course of the conference.
A2LA was one of approximately 100 exhibitors that attended the conference, many of which were our accredited laborato-
ries. The conference allowed us to meet with professionals and experts in the calibration arena and explain the benefits that
accreditation has to offer. It was also a valuable opportunity for our accredited laboratories and other interested parties to
meet with A2LA staff in person and have any of their questions regarding accreditation answered. We look forward to next
years conference which is scheduled for July 25 July 29, 2010 in Providence, Rhode Island. The theme for 2010 will be 21st
Century Innovations in Metrology.
We at A2LA wish to express our sincere thanks to those who stopped by the A2LA booth with questions regarding our ac-
creditation programs. For inquiries or questions regarding the accreditation programs offered by A2LA, please contact A2LA
headquarters at 301 664 3248 or visit us on the web at: http://www.A2LA.org/.

10
International Activities

A2LA Well Represented in Producing


the New International Standard for
Proficiency Testing
By Dan Tholen, A2LA Assessor

ISO/IEC 17043 (Conformity assessment - General requirements


for proficiency testing) will soon be an approved International
Standard, and A2LAs influence will run throughout the docu-
ment. ISO CASCO Working Group (WG) 28 held their 5th
and possibly final meeting on June 29-July 1 in Milwaukee and
recommended that FDIS 17043 be advanced to ballot as an ap-
proved International Standard. If the ISO and IEC ballots are
successful the Standard will be published in early 2010.
WG28 consisted of 57 experts from 33 different countries and
providers seeking accreditation. Many accrediting bodies, par-
5 liaison organizations. While the WG is representative of the
ticularly in Europe, have delayed offering accreditation of PT
entire ISO CASCO membership, including all areas of con-
providers until there was an ISO standard. Currently A2LA
formity assessment and countries, 7 of the members of WG28
accredits 16 PT providers, which also places A2LA among the
have direct ties to A2LA - by far the most of any accrediting
global leaders, along with NATA (Australia) and UKAS (United
body. Several A2LA assessors and experts from A2LA-accred-
Kingdom).
ited organizations participated extensively on WG28. Assessor
and A2LA Member, Dan Tholen, served as Convener of WG28 If, as expected, ISO/IEC 17043 is approved by the ISO and IEC
and was supported by assessors, Jeff Gust (Measure PT), Arlene memberships in late 2009, a cascade of events will occur quickly
Fox (AOAC International), and Werner Schaefer (Cisco Sys- - many accrediting bodies (including A2LA) will use it, rather
tems). Also on the Working Group were Henrik Nielsen (HN than ILAC G13, as the general requirements for accreditation;
PT - representing Denmark), Tony Russell (formerly of NATA, ILAC will withdraw G13 as a current document; APLAC and
Australia), and Tom Coyner (formerly of APG, Inc.) - all from ILAC (and possibly other regions) will begin negotiations to ex-
organizations accredited by A2LA as PT providers (as are Mea- tend the Mutual Recognition Agreement to include PT provid-
sure PT and AOAC International). Dan, Jeff, Arlene, Henrik, ers; and 17043 will become an EN standard - giving it the force
Tom, and Tony all attended the meeting in Milwaukee. of law in Europe (according to the Vienna Agreement). Several
accrediting bodies, APLAC, and IAAC are all planning training
ISO/IEC 17043 is a revision of ISO Guide 43-1 and 43-2
for PT providers and assessors to prepare for the transition.
(1997). It used ILAC G13:2007 as a base document, and, like
ILAC G13, it shares a lot of requirements with ISO/IEC 17025. The new standard retains most of the management system re-
The revision resulted from an urgent request from ILAC in a quirements of 17025 (and ILAC G13), with a few changes to
Work Item Proposal filed in June 2006. The work item was ap- reflect changes in ISO 9001 made since 2005 as well as some
proved by CASCO members and the first meeting of WG28 oc- wording changes for clarity. The technical requirements are very
curred in December 2006. The rapid progression of the project similar to ILAC G13, but contain a few major changes; most sig-
reflects the urgency felt by ILAC members - it is very unusual nificantly, PT providers in the calibration area will be required
to have a Standard approved in less than 3 years from the start to use assigned values with metrological traceability and PT pro-
of work (4-5 years is typical; 7 years is not unusual). While viders in other areas will need to at least consider the traceability
it is not clear how many ILAC members offer accreditation of and uncertainty necessary to assure that the assigned values are
PT providers, the number is growing, as are the number of PT fit for their intended use. Consensus values are allowed in non-

Continued on page 12

11
International Activities
Continued from page 11

calibration areas, but providers will be required to demonstrate feeling that the most important benefit of PT is as a tool for
the suitability of the values. The other significant change is that quality improvement. PT providers see results from all methods
PT providers will not be allowed to subcontract the design of in use, they see how mistakes can occur, and they know what
the PT scheme, the evaluation of performance, or the authoriza- participants do to best agree with the assigned value - knowl-
tion to issue the final reports. Less significant changes include edge that should be shared with all participants.
the need to report the uncertainty of the assigned values and to The members of the writing group brought to WG28 the val-
include more information in the final report, including sum- ues that are shared throughout A2LA - external verification of
mary statistics for different methods used by participants and competence, traceability of measurements, and continual qual-
general technical comments on performance. These changes ity improvement for all laboratories. The new standard reflects
are based on the experience of the members of WG28 and their that commitment.

The American Association for Laboratory Accreditation


World Class Accreditation 5301 Buckeystown Pike, Suite 350
Frederick, Md 21704

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