National Cooperation for Laboratory Accreditation

NACLA'S
IMPORTANT MISSION
AND
CURRENT STATUS
HOW NACLA
EVALUATES AND RECOGNIZES
LABORATORY ACCREDITATION BODIES

April 7, 2003

National Cooperation for Laboratory Accreditation z P.O. Box 4045 z Gaithersburg, MD 20885-4045
(301) 975-6472 z Fax: (301) 963-2871
 National Cooperation for Laboratory Accreditation

April 7, 2003

Dear NACLA Stakeholders:

NACLA's objectives in 2003 include improved communications with all its constituents
and more transparent operations. The attached White Paper on NACLA's Important
Mission and Current Status serves to advance both objectives.

At the present time, there is confusion and misrepresentation in the marketplace about the
NACLA recognition process and about the roles and motivations of some of NACLA's
most generous supporters. The confusion and misrepresentation are based on a lack of
adequate understanding of why and how NACLA operates its recognition system. For
example, many do not realize that the system functions in a manner that is totally
independent from the NACLA officers and Board of Directors/Operations Council.

Our hope is that this paper will benefit all stakeholders, by deepening their understanding
of NACLA's basic mission and its primary activity, the recognition of qualified and
competent U.S. accreditation bodies.

We urge you to learn more about NACLA and to communicate with its leaders by
becoming a frequent visitor to the NACLA web site, www.nacla.net, and by using that
medium to express your concerns, questions and suggestions.

We hope to hear from you often. We encourage you to become an active supporter of
NACLA, by joining our organization and getting involved in its programs.

Sincerely,

Dr. Louis T. Dixon

National Cooperation for Laboratory Accreditation z P.O. Box 4045 z Gaithersburg, MD 20885-4045
(301) 975-6472 z Fax: (301) 963-2871
 THE HISTORY AND EVOLUTION OF NACLA’s RECOGNTION PROGRAM
The theme of 2002 World Standards Day was
"One Standard, One Test, Accepted
Everywhere." The purpose of this paper is to
explain the role of one of the many organizations
that are working to achieve this ambitious goal.
The organization is the National Cooperation for
Laboratory Accreditation (NACLA).
NACLA is a U.S. not-for-profit entity,
incorporated in 1998. It focuses particularly on
the one-test element of the theme by recognizing
accreditation bodies that demonstrate
competence in their work of assessing and
accrediting laboratories capable of producing
accurate test and calibration data. To appreciate
the part that NACLA plays in this scenario, it is
necessary to understand several phenomena:
• The role of laboratory accreditation;
• The international system for evaluating
laboratory accreditation bodies (ABs); and
• The unique accreditation situation in the U.S.
Laboratory Accreditation
Accreditation of laboratories is a process
intended to provide confidence to users of the
services of testing and/or calibration
laboratories. Users want some assurance that the
laboratory with which they contract is capable
of providing the services they offer and can
produce accurate data. One means of gaining
this confidence is by first hand monitoring of
the laboratory. Over time, most users have come
to appreciate that assessing and accrediting of
the laboratory by a third party is a more
efficient means to that end.
International System
Since its founding in 1978, the
International Laboratory Accreditation
Cooperation (ILAC) has worked at continuously
improving the quality of laboratory accreditation
and creating a uniform worldwide system of
accreditation, as a means to ensure reliable
laboratory data and to facilitate trade. The initial
work on the standards for competent laboratories
- for many years, ISO/IEC Guide 25, and now
Page 1
ISO/IEC 17025 - was carried out within ILAC.
ILAC also prepared the early drafts of the
worldwide standard for a competent AB -
ISO/IEC 58.
ILAC is basically an organization of ABs
from almost all countries of the globe. Other
stakeholder groups participate to a limited degree
but only ABs are full-fledged ILAC members.
Accordingly, when ILAC developed a system for
evaluating the competence of ABs, it devised a
pure peer-review system, i.e., staff from several
ABs evaluating the operations of the applicant
AB. Further, regional "cooperations" were
established to carry out these evaluations. The
two mature cooperations are EA (the European
co-operation for Accreditation) and APLAC (the
Asia Pacific Laboratory Accreditation
Cooperation). Each cooperation has established
its Mutual Recognition Arrangement (MRA)
which is signed by those ABs within the region
that have demonstrated their competence to the
satisfaction of other members of the cooperation.
When an AB within the region wishes to
sign the region's MRA (and thereby be
recognized by its peer ABs), an evaluation team
of peers conducts a comprehensive evaluation of
the applicant. When the team believes that the
applicant is in compliance with ISO/IEC 58 and
ancillary protocols of the cooperation, it presents
the data to current MRA signatory bodies, who
vote on whether to invite the applicant to sign
the MRA and be recognized. ABs that are
signatories of either the EA or APLAC MRAs
are automatically invited to sign the ILAC MRA.
Currently, 41 ABs from around the world are
signatories of the ILAC MRA.
The objective of the ILAC system is to
facilitate world trade by creating confidence
within industry and government that, if data
coming from another nation have been produced
by a laboratory that is accreditated by an ILAC-
MRA-signatory AB, there can be confidence in
the reliability of the data and there is no need to
reverify its accuracy. Hence, the ILAC system
supports the industry mantra and World
Standards Day theme: One test or calibration
accepted everywhere.
 Unique U.S. Accreditation Situation
In almost all countries of the world, there
is a single body that accredits laboratories; e.g.,
in the UK that is UKAS; in France, it's
COFRAC; in Mexico, it's ema; and in Canada,
it's SCC. Each has direct or indirect endorsement
from the government and operates, for the most
part, with no competition. The situation within
the U.S. is entirely opposite. There are scores of
laboratory accreditation bodies: some created by
government agencies, some by industry, some by
assocations, some nonprofit, some for-profit. A
number of them compete with each other for
business.
In addition, the standards for
accreditation are an area of significant
differences. Most ABs around the world have
either joined ILAC or wish to - and they base
their system on the ISO/IEC 58-17025 standards.
Within the U.S., many of the ABs have
customized standards that have traditionally
suited the needs of the organizations that rely on
them. Most of these have not yet switched to the
ISO/IEC standards.
The uniqueness of the U.S. situation
makes this country's alignment with the
international system much more difficult than is
the case in the UK, France, Mexico and Canada.
However, if for no other reason than the trade
interests of U.S. companies, it important that the
U.S. accomplish this alignment.
NACLA’S Mission
NACLA was established with a mission
to coordinate the diversified U.S. laboratory
accreditation activities and to help U.S. ABs
achieve international recognition. But the
founders of NACLA believed there was a flaw in
the ILAC structure - the dominant role of ABs.
Therefore, NACLA was formed as a stakeholder
organization, with balanced representation on its
policy body from four stakeholder groups:
Industry, Government, laboratories and ABs.
Because one of NACLA's goals is to
prepare U.S. ABs for the ILAC system and,
ultimately, to be itself accepted by ILAC as a
regional cooperation, NACLA bases its
recognition of competent ABs on the ISO/IEC
Page 2
58-17025 standards; and it has developed an
MRA, which ABs that have demonstrated
competence are invited to sign. However, the
NACLA evaluation and recognition systems are
also more democratic than those of the current
ILAC regions. Instead of a pure peer system,
NACLA evaluation teams include
representatives of industry and Government as
well as of peer ABs; and the final vote on the
competence of an evaluated applicant is taken by
persons from the three stakeholder groups.
NACLA's modifications of the ILAC system
provide important checks and balances on the
influence of ABs that operate in the diversified
and sometimes competitive U.S. market.
The NACLA Organization
NACLA was incorporated in 1998 and it
is still maturing. (This is not unusual for
cooperations; ILAC was established in 1978 and
was not even incorporated until 2002.) NACLA
has limited funding and a staff of two part-time
persons, and it depends heavily on a cadre of
dedicated volunteers from its stakeholder groups.
Board and committee members contribute their
time and talent. Further, members of evaluation
teams receive no compensation, but only have
their travel expenses reimbursed by the AB being
evaluated.
Understandably, NACLA relied heavily
in establishing its recognition system upon
persons familiar with ILAC and its operations.
Two ABs have been active in ILAC for more
than 20 years: The American Association for
Laboratory Accreditation (A2LA) and the
National Voluntary Laboratory Accreditation
Program (NVLAP), which is part of the U.S.
Department of Commerce’s National Institute of
Standards and Technology. Fortunately, both of
them have been more than generous in helping
NACLA get off the ground, by providing
expertise, staff members to chair and serve on
NACLA committees, Board and evaluation
teams, and in other ways. The contributions from
both organizations, in terms of dollars and
volunteer person-hours, over the past five years
are incalculable.
Ironically, of the 100+ U.S. ABs, none
need NACLA less than A2LA and NVLAP do.
Both gained national recognition many years
ago. Both are leaders in APLAC and ILAC. Both
have achieved signatory status in APLAC and
ILAC MRAs. NACLA recognition adds little if
anything to their stature. This makes their
invaluable contributions to NACLA even more
remarkable.
The NACLA Evaluation/Recognition Process
NACLA recognition is neither easily nor
quickly gained by any applicant AB, no matter
how qualified it may be. The protocols of the
recognition process are contained in NACLA's
Accreditation Body Recognition Procedure
document, which can be viewed on NACLA's
web site (www.nacla.net). Even a casual review
of the document will make it clear to the reader
that NACLA evaluates all applicants carefully
and rigorously. Consider one aspect alone - the
scheduling of pre-evaluation and evaluation
visits. Coordinating the schedules of the
evaluation team members, the key AB personnel,
and the several laboratory assessments to be
observed is a challenging and time-consuming
process. As with ILAC and EA, working one's
way through the evaluation process normally
takes two years. And it can take longer, when the
AB has difficulty bringing its accreditation
system into compliance with NACLA
requirements.
It is important to note that there is a clear
separation of powers when it comes to NACLA
recognition. The Board of Directors/Operations
Council sets the policies that govern the
evaluation-recognition processes, but the
Board/Council has no role in the evaluation itself
nor in the decision on whether to recognize an
applicant AB. The latter is the role of the
Acceptance Panel, composed of ABs and
specifiers.
NACLA's Progress in Recognition of ABs
NACLA's challenge is daunting, given
the rigorous ILAC requirements for
cooperations, NACLA's limited resources, the
lengthy and comprehensive international AB-
evaluation process, and the fact that the
evaluation process is carried out, as a career
Page 3
sideline, by volunteers, most of whom have
demanding full-time jobs that must take
precedence over their commitments to NACLA.
Further, most applicants for NACLA recognition
are either newly established or have not based
their systems on ISO/IEC 58-17025. For them,
meeting the requirements of these standards and
of additional NACLA requirements is at least as
daunting as is NACLA's task of evaluating them
to these protocols. Not surprisingly, therefore,
NACLA is making progress that is slow and
steady.
To date, NACLA has fully evaluated and
recognized four ABs. The four, which are
signatories to the NACLA MRA are: A2LA,
AIHA (the American Industrial Hygiene
Association), IAS (the Internationl Accreditation
Service)and NVLAP. NVLAP and A2LA were
founded in the 1970's and have national and
international stature and acceptance as was
noted above. AIHA and IAS are more narrowly
focused programs that serve a few segments of
the commercial marketplace; both have many
years of experience and well developed
infrastructures. Like A2LA and NVLAP, ICBO
ES is a signatory to both the APLAC and ILAC
MRAs. In addition, eight other U.S. ABs have
applied for NACLA recognition and are in
various stages of the lengthy evaluation process.
NACLA's Assistance to Government Agencies
• The National Institute for Standards and
Technology (NIST). Under the National
Technology Transfer and Advancement Act,
of 1996, the U.S. Congress gave NIST the
charge to coordinate U.S. standards and
conformity assessment activities, which
include laboratory accreditation. On July 7,
2000, NIST signed a memorandum of
understanding (MOU) with NACLA, under
which NACLA helps NIST to meet its
coordination responsibilities. Among other
things, NIST commits to accept NACLA
recognition of ABs that accredit laboratories
to the technical requirements of international
mutual recognition agreements in which
NIST is named as the U.S. designating
authority; To encourage government
 agencies at all levels to accept the use of
laboratory accreditation bodies recognized by
NACLA; and To treat NACLA recognition
of ABs as a suitable alternative to direct
NIST recognition under its National
Voluntary Conformity Assessment System
Evaluation (NVCASE) program. NACLA,
for its part, agrees to submit to periodic third-
party assessments; To maintain impartiality
and integrity in its recognition program; and
To follow accepted international standards
and guides and accommodate relevant
government requirements.
• Department of Energy (DOE). In 2002, the
DOE Primary Standards Laboratory
approved the use of accredited commercial
calibration laboratories in support of the
DOE Nuclear Weapons Complex, provided
that the accreditation was awarded by a
NACLA-recognized AB. This will enable
DOE gradually to eliminate the on-site audits
conducted by DOE personnel; saving the
Government the $5,000 to $10,000 that each
audit costs.
• Federal agencies that rely on construction
materials testing laboratories. Recently the
NACLA Board/Council tentatively agreed to
evaluate ABs that wish to be recognized for
their competence to accredit construction
materials testing laboratories to a set of
special technical requirements that will meet
the needs of four Federal agencies: the
Federal Highway Administration, the Federal
Aviation Administration, the U.S. Army
Corps of Engineers and the Bureau of Land
Reclamation. Representatives of these four
agencies and of several ABs and other
stakeholders served on the NACLA
Technical Requirements Subcommittee Task
Group that developed the requirements.
• The Nuclear Regulatory Commission
(NRC). Another NACLA Task Group has
been working with officials of the NRC and
some major power companies to develop a
protocol acceptable to the NRC, whereby
tests and calibrations by laboratories
accredited by a NACLA-recognized AB will
be accepted by the NRC. The group made
significant progress in 2002; it is hoped that
Page 4
the project will be successfully completed in
2003.
NACLA's Assistance to the Automotive
Industry
In 2000, the U.S. auto manufacturers - at
least GM and Daimler Chrysler - adopted a
revised version of their quality systems standard,
QS 9000. The new standard introduced a
requirement that all laboratories used by
suppliers had to have equipment calibrated by an
accredited laboratory. At the time, most of the
thousands of affected calibration laboratories
were not accredited, so the new requirement
created a sudden demand for accreditation
services. The supply of available accrediting
bodies (basically A2LA and NVLAP) was
considered inadequate in light of this huge
demand. So a number of new ABs were founded.
GM and Daimler Chrysler learned of
NACLA's existence and a dialogue between
NACLA officials and auto officials was initiated.
The automakers wished to have some assurance
of the competence of the ABs upon which they
would rely. NACLA explained that gaining
recognition was a lengthy process even for
mature, experienced ABs and that for a new AB
it would take years to put all the
infrastructure together, implement its full system
and gain the required amount of experience to be
ready for a full evaluation. However, NACLA
expressed its desire to help this major industrial
sector. The following plan was jointly
developed.
It was agreed that NACLA would
conduct document reviews and pre-evaluations
of the recently established ABs that had applied
for recognition. Further, with the approval of
these ABs, a representative of the automakers
would participate as an observer on each pre-
evaluation team. As is customary in the NACLA
process, each AB would receive a pre-evaluation
report, with a list of the deficiencies discovered
by the pre-evaluation team. Designated officials
of GM and Chrysler would also receive the
reports. Then, on the basis of the reports and the
observations of the team observer, automakers
would make their decisions about which ABs
would be put on the GM and Daimler Chrysler
list of approved ABs. And NACLA would then
continue the process of evaluating the ABs. This
plan was implemented in the spring of 2001.
Four new ABs were pre-evaluated and reports
were issued in the summer of 2001. The
automakers received those reports and
presumably based their decisions on approval of
ABs on those data. Meanwhile, the new ABs are
continuing to progress toward possible NACLA
recognition.
Arrangement with Standards Council of
Canada
In March of 2001, NACLA signed an
arrangement with the Standards Council of
Canada (SCC). Under it, SCC agrees to
recognize the accreditations of NACLA-
recognized ABs, who, in turn, agree to recognize
the SCC accreditations. Further, both agreed to
promote to all interested parties the recognition
of the test and calibration reports issued by all
the accredited laboratories of all Parties to the
arrangement. The arrangement also specifies that
SCC and NACLA will cooperate in the
development and operation of proficiency testing
programs and interlaboratory comparisons.
Recent Initiatives to Enhance NACLA's
Service to Stakeholders
As it evolves, NACLA is learning from
its early experiences and is making changes to
continuously improve its performance. Shortly
after he took office, on January 1, 2003,
NACLA's current President, Dr. Louis Dixon
announced that the two main objectives of his
administration would be: improved customer
service and more efficient NACLA processes.
"Among the lessons I learned during my
automotive industry career," he said, "is that
success comes only by understanding customer
needs and meeting these needs with efficient
processes. Several process improvements were
made in the past year - Giving industry and
government representatives the opportunity to
vote with recognized ABs on the recognition of
applicant ABs; and streamlining the NACLA
organizational structure. I plan to continue this
Page 5
improvement process and make a special effort
to inform and listen to NACLA's customers."
Several steps were taken in the first
quarter of 2003 to achieve these objectives:
• Expanded Annual General Meeting
(AGM). On March 19, following NACLA's
annual Laboratory Accreditation Forum,
NACLA expanded the time of its AGM from
an hour to an afternoon to allow for a full and
open dialogue between its stakeholders and
leaders. Stakeholders offered their criticisms
and suggestions and NACLA leaders
promised to consider them carefully and take
action where warranted. Among the
comments: there is need for better
communications and more transparent
operations; applicant ABs have to wait too
long for service from NACLA and its
evaluation teams; an evaluation timeline
should be established; Paid evaluators should
be used, because total dependence on
volunteer evaluators makes a complicated
process even more difficult to implement;
NACLA should make it easier for
stakeholders to get involved on its
committees and to attend committee
meetings; signatories to the NACLA MRA
should accept the assessments of other
signatories.
• Modifications in Evaluator protocols. The
NACLA Board of Directors/Operations
Council met on March 20. Even before the
previous day's AGM, recommendations for
improving the efficiency of the evaluation
process had been proposed by the
Recognition Committee Chair. The
Board/Council adopted a number of
modifications aimed at improving the
process and offering better customer service.
o Payment of Lead Evaluators. Qualifed
lead evaluators are the most important
persons in the evaluation/recognition
process and they are in short supply.
From now on, they will be paid a fee for
their services, in hopes that this will
attract an increased number of qualified
candidates for the job.
o Use of Lead Evaluators from Other
Countries. The Board/Council
encouraged the Recognition Committee
Chair to reach out to other accreditation
cooperations, like APLAC and ILAC to
invite experienced Lead Evaluators to
lead NACLA teams.
o More flexibible Criteria for Lead
Evaluators. As a further means of
increasing the Lead Evaluator pool, the
Board/Council voted to permit the
appointment of exceptional candidates
who do not meet the letter of the current
Lead Evaluator criteria but who are
trained as evaluators and who, because
of their abilities, merit the approval of
the Recognition Committee Chair, the
Training Subcommittee Chair, the
Executive Committee and 3/4ths of the
signatories to the NACLA MRA.
o Opportunity for Applicants to have a
Second Pre-Evaluation On-site Visit.
Current practice is for the average
applicant AB to have one pre-evaluation
on-site visit from a small evaluation
team, and then, after implementing
changes dictated by the team's findings,
to have a full-bore evaluation by the
entire team. In response to requests
from applicants, the Board/Council
approved offering applicants the
opportunity for a second pre-evaluation
visit by the Lead Evaluator or another
team member, to check on the AB's
progress.
o Evaluation Timeline. Again, in
response to customer requests, a
timeline for processing
applications/evaluating ABs, that covers
Page 6
expected performance of both ABs and
NACLA, will be developed.
• Addressing Concerns about NACLA
MRA. During its March meeting, the Board/
Council received a report from its MRA
TaskGroup and then it took several actions. It
decided to ask the four signatory ABs to
review and revise the MRA, taking into
account specific Task Group
recommendations that address stakeholder
concerns. It charged the Task Group to
develop additional documentation to support
the implementation of the MRA, such as
guidance to MRA signatories on
interpreation of MRA commitments. And it
appointed a group of NACLA leaders to
initiate a dialogue with the signatory ABs
about practical means to reduce overlap and
duplication in laboratory assessments
conducted in the same laboratory for the
same field of testing.
Conclusion
NACLA will continue to evolve and
improve in the coming months and years, as it
seeks to meet its serious obligation to evaluate
all applicant accreditation bodies rigorously and
thoroughly and to recognize only ABs that have
demonstrated that they fully comply with
NACLA's high standards for competence. Visit
NACLA's website, www.nacla.net, to keep
abreast of its progress. Join and get involved in
NACLA to help accelerate its progress and its
effectiveness in the pursuit of its challenging
objective: "One test or calibration, accepted
everywhere."
x x x