ACLASS Frequently Asked Questions
About the ANSI-ASQ National Accreditation Board
Technical Questions Related to Accreditation
About the ANSI-ASQ National Accreditation Board
What is ANSI-ASQ National
The ANSI-ASQ National Accreditation Board is a non-profit,
non-governmental organization that provides accreditation services
to public- and private-sector organizations. ACLASS, FQS,
and ANAB are the three brands of the ANSI-ASQ National
Accreditation Board, which is jointly owned by the American
National Standards Institute (ANSI) and the American Society for
Why should I use the services
of the ANSI-ASQ National Accreditation Board/ACLASS?
ACLASS is committed to customer service and technical competence
and maintains international recognition. We provide quality and
value to our customers. Our staff and assessors are technically
competent, personable, and effective communicators. This ensures a
more beneficial and pleasant experience for our customers.
What's the mission of
the ANSI-ASQ National Accreditation Board?
The mission of the ANSI-ASQ National Accreditation Board is to
be a leader in guiding the international development of
accreditation processes that build confidence and value for
stakeholders worldwide and providing high quality and reliable
accreditation services with the most professional value-added
services for customers and end users.
Does the ANSI-ASQ National
Accreditation Board have a quality policy?
Yes. The ANSI-ASQ National Accreditation Board:
- Is committed to being a value-added, competent, and
cost-effective provider of accreditation of conformity assessment
services to national and international standards with the highest
integrity and in a timely manner.
- Will advance the credibility of accreditation by maintaining
mutual recognition agreements that advance international acceptance
of conformity assessment.
- Will provide its customers the best accreditation and
assessment services possible while helping its customers and other
interested parties focus on achieving and providing value.
- Will provide its employees a satisfying work environment that
encourages teamwork and high performance.
What are the benefits of
Accreditation provides formal recognition to competent
organizations. It provides a conduit for regulators and industry to
find reliable products and services to meet their specific needs.
Accreditation is a means to reduce costs and redundancy and
eliminate trade barriers. Most important, accreditation assures
industry and government decision-makers that accredited
organizations are competent and their results can be relied on.
What companies are accredited
These are just some of the organizations accredited by
||NASA Johnson Space Center
|American Type Culture Collection (ATCC)
||National Insitute of Health, Peru
|Browne and Sharpe/Hexagon Metrology (Romer, Sheffield)
||Standards Institute of Israel
|Columbia Food Labs
||Sypris Test & Measurement
||Thermo Fisher Scientific
|Lockheed Martin (including Stennis Space Center)
How are ACLASS, ANSI, ANAB, and
ASQ related, and what's the history behind the company
The ANSI-ASQ National Accreditation Board is jointly owned by
the American National Standards Institute (ANSI) and
the American Society for Quality (ASQ). We have
three brands: ACLASS, FQS, and ANAB. ANAB is the U.S. accreditation
body for management systems (for example, ISO 9001) certification
bodies, and FQS provides accreditation for ISO/IEC 17025 forensic
test agencies and ISO/IEC 17020 forensic inspection agencies.
ACLASS provides accreditation for ISO/IEC 17025 calibration and
testing laboratories, ISO/IEC 17020 inspection bodies, ISO Guide 34
reference material producers, ISO/IEC 17043 proficiency testing
providers, and (through ANSI) ISO Guide 65 product certifiers.
ACLASS also has industry-specific programs for the EPA National
Lead Laboratory Accreditation Program, TNI Proficiency Test
Providers, National Environmental Field Activities Program, the
Department of Defense Environmental Laboratory Accreditation
Program, the Consumer Product Safety Commission Requirements for
Children's Products, EPA Energy Star, ISA Secure, and Food Test Lab
Accreditation. In addition, ACLASS offers a variety of training
courses related to its accreditation programs.
As the voice of the U.S. standards and conformity assessment
system, ANSI empowers its members and constituents to strengthen
the U.S. marketplace position in the global economy while helping
to assure the safety and health of consumers and the protection of
the environment. ANSI oversees the creation, promulgation, use of
thousands of norms and guidelines that have a direct impact on
businesses in nearly every sector. ANSI also offers accreditation
for product and personnel certifiers and greenhouse gas
ASQ has been the world's leading authority on quality for more
than 60 years. With more than 93,000 individual and organizational
members, the professional association advances learning, quality
improvement, and knowledge exchange to improve business results,
and to create better workplaces and communities worldwide. As a
champion of the quality movement, ASQ offers technologies,
concepts, tools, and training to quality professionals, quality
practitioners, and everyday consumers. ASQ has been the sole
administrator of the Malcolm Baldrige National Quality Award since
Is ACLASS recognized
domestically and internationally?
ACLASS is a signatory of the multilateral recognition
arrangements (MRAs) of the International Laboratory Accreditation
Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation
Cooperation (APLAC). ACLASS is also a signatory of the
Inter-American Accreditation Cooperation (IAAC) multilateral
recognition arrangement (MLA). Domestically, ACLASS has been
recognized by the Federal Communications Commission, the National
Institute of Standards and Technology (NIST) National Voluntary
Conformity Assessment Systems Evaluation Program (NVCASE), the
NELAC Institute (TNI), and many other private and government
How does ACLASS demonstrate its
capability as an accreditation body?
ACLASS, like other MRA-signatory accreditation bodies, is
evaluated every four years by its peers in the international
accreditation community. This includes evaluation of its compliance
with the requirements of ISO/IEC 17011, Conformity assessment -
General requirements for accreditation bodies accrediting
conformity assessment bodies. (In this context, "conformity
assessment bodies" refers to calibration and testing laboratories,
inspection bodies, PT providers, and reference material producers.)
The evaluators also accompany ACLASS assessors and staff on select
assessments to evaluate the diligence and appropriateness of the
assessment process to conform with ISO/IEC 17011 and the relevant
standard used to assess the conformity assessment body.
How do I start the
Call ACLASS at 877-344-3044 to begin a mutually beneficial
dialog. We start by gathering information and in a short time can
recommend specific guidance documents, provide pricing information,
explain the estimated timeline of accreditation for your company,
and answer any questions. Then we'll send a quote, application for
accreditation, and all necessary documentation. You can also
download a request for quote and an application from this
I need help preparing for
accreditation; can ACLASS help?
We offer several types of preparatory evaluations prior to the
assessment; however, we cannot engage in consulting. We have tools,
resources, and contacts to which we can direct you to help you get
What information is available
to ACLASS customers?
ACLASS has an open system. Customers have access to any
documentation that's not restricted based on privacy, accreditation
mandate, or other legal issues. This includes checklists used in
the accreditation process.
How much advance notice is
provided in scheduling assessments?
Assessment schedules for current customers are maintained
approximately 120 days in advance. Customers typically receive
assessment schedules 30 to 60 days in advance.
How long will it take to be
notified of accreditation results after the
At the end of the accreditation assessment, you'll receive a
copy of the assessor checklist and any nonconformances. The
assessor will tell you prior to leaving the facility if your
company will be recommended for accreditation. After corrective
action responses are approved, ACLASS will begin the accreditation
decision review process. A certificate and scope of accreditation
are issued if your company is approved for accreditation.
How is the scope of lab
The scope is a detailed description of the specific tests and/or
calibrations for which your laboratory is accredited. To ensure
consistent uniformity for all scopes of accreditation, the format
must be written in accordance with NIST 811, Guidelines for the
Expression of SI Units. Also refer to the ACLASS Guidance Document
on Scopes of Accreditation.
Are all ACLASS fees disclosed
in my quote?
The only charges not included in our quotes are for actual
travel costs, any time for corrective action review, and
reimbursement for assessor travel time. If travel is required, we
try to keep expenses to a minimum. ACLASS monitors assessor travel
arrangements to ensure costs are as low as possible. Assessment
time (days on site) may vary depending on the complexity of the
proposed scope of accreditation.
How can I inform my customers
that my company has applied for any ACLASS
ACLASS provides a letter stating that accreditation is in
progress so your customers understand you're working to become
What's the difference between
CMC and MU?
CMC stands for calibration and measurement capability, while MU
stands for measurement uncertainty. CMC is a calibration
laboratory's "best capability." This means calibration was
performed using the best standards, with the smallest uncertainty,
the smallest error, and under the best environmental conditions,
with calibration performed on a very high-end piece of equipment.
In other words, the calibration is as near ideal as possible for a
given calibration laboratory. These CMC values are reported on your
scope of accreditation.
Because a calibration laboratory cannot always work in its best
environment and with its best reference standards, it needs to
calculate an MU for each particular instrument it calibrates. In
this case, the laboratory needs to estimate the uncertainty, taking
into account potentially larger uncertainties and errors (compared
w those in its CMCs) from its working standards, the contribution
of more environmental variance, and possibly use of a lower-end
piece of equipment with less resolution.
What will my assessor look for
when reviewing my CMC budgets?
First, the assessor will want to see your procedure for
calculating the uncertainty budgets. The procedure should include a
method for identifying all the potential error contributors for a
calibration. It should also refer to any software you intend to use
and the coverage factor you'll be reporting (usually k=2). You
might also want to describe when and why a contributor may be
excluded because it won't be significant.
The second area to be reviewed will be the contributors in your
uncertainty budgets to see how they were determined. We'll verify
the uncertainty from your calibration certificates to make sure
they're correct. We'll look at standard error from the calibration
certificates, repeatability studies, contributions of environmental
variance, deflection, etc.
Last, we'll review uncertainty budgets to make sure you're using
the proper distributions in the calculations. It's very important
that these are correct because the budgets could be over- or
understated dramatically if these are improperly applied.
ACLASS has an easy to understand guidance document its
Why is it important to use
accredited laboratories for calibration of standards?
ISO/IEC 17025 Section 220.127.116.11.1 states:
"When using external calibration services, traceability of
measurement shall be assured by the use of calibration services
from laboratories that can demonstrate competence, measurement
capability and traceability. The calibration certificates issued by
these laboratories shall contain the measurement results, including
the measurement uncertainty and/or a statement of compliance with
an identified metrological specification (see also 18.104.22.168).
"NOTE 1: Calibration laboratories fulfilling the
requirements of this International Standard are considered to be
competent. A calibration certificate bearing an accreditation body
logo from a calibration laboratory accredited to this International
Standard, for the calibration concerned, is sufficient evidence of
traceability of the calibration data reported."
To calculate your CMCs, you will need certain information from
your calibration provider. Pay particular attention to the note. In
some cases, the manufacturer may be an acceptable source for
calibration of calibration equipment. Review the requirements in Document 3 or contact your Accreditation
Does ACLASS offer accreditation
to ANSI-NCSL Z540-1 and Z540.3? How does the assessment differ from
the ISO/IEC 17025 assessment?
We continue to offer assessment of the requirements of both
standards for our ISO/IEC 17025 customers. For ANSI-NCSL Z540.3, we
assess the requirements of section 5.3, the only section not
already covered during the ISO/IEC 17025 assessment. This requires
an additional half-day of assessment time during initial assessment
and reassessment. The checklist used during this assessment is
available on the website. The scope and certificate of
accreditation will refer to both standards when they've been
Although ANSI-NCSL Z540-1 has been replaced by Z540.3, it's
still referred to in some of our customers' contracts and we
therefore offer it to customers who request it. The additional
requirements are included in the ISO/IEC 17025 checklist and
identified as "Z540-1." No additional assessment time is
required. The scope and certificate of accreditation will refer to
both standards when they've been verified.
For ISO/IEC 17025 customers who request assessment to both of
these national standards, the scope and certificate of
accreditation will refer to all three standards.
Do test labs have to estimate
Every ISO/IEC 17025 accredited lab needs to be diligent about
uncertainties, including all testing labs. In fact, all ISO/IEC
17025 accreditation visits must include verification that the
laboratory has demonstrated this diligence. There must be a
documented procedure in the system describing how uncertainties are
handled. For some testing labs, this may be a simple statement that
all tests are qualitative and not quantitative and they do not need
to determine any uncertainties. Most testing labs do not need to
calculate or demonstrate what we call ISO-GUM uncertainties for all
relevant uncertainties for tests on their scope of accreditation.
They rarely if ever might report an uncertainty on any test report
either. They only need to demonstrate to their ISO/IEC 17025
assessors with a few specific examples how they would calculate
those MUs for a customer requesting them.
Do we need to participate in
proficiency testing or inter-laboratory comparisons (PT/ILC) before
our initial assessment? Do we need to demonstrate participation for
every discipline on our proposed scope of accreditation? What about
ACLASS requires that applicant labs demonstrate proof of
participation in a test that meets the requirements of ISO/IEC
17043 prior to the initial assessment visit, whenever
possible. This means that the lab must have participated and
provided its input to the provider, but the results may or may not
be available yet. The lab is required to forward the results to
ACLASS when they are available. If no results have been received
within six months of accreditation, the accredited laboratory is
subject to suspension until ACLASS receives them. The minimum
required participation prior to the initial assessment visit is one
discipline from the proposed scope of participation.
Following the initial accreditation, ACLASS requires that
accredited labs participate in at least one PT/ILC each calendar
year. In addition, the lab must participate in at least one PT/ILC
for each major sub-area of its scope of accreditation during any
calendar four-year period. Major sub-areas are identified on the
scope of accreditation by Roman numerals (I. Dimensional
Calibration, II. Thermal Testing, etc.).
What is a scope of
The scope of accreditation is a document listing a laboratory's
specific test or calibration capability as verified by the
accreditation body. For a calibration laboratory, the scope
includes the type of test or calibration, range or detection
limits, reference standards, and procedures used and the
calibration and measurement Capabilities (CMCs). The scope refers
to a certificate of accreditation.
The laboratory I've been using
for calibration of my standards says it complies with ISO/IEC 17025
but only has an ISO 9001 certificate on their website.
Chances are it is not accredited. Laboratories accredited by an
accreditation body that is a signatory to the ILAC mutual
recognition arrangement (MRA) have been assessed to all the
requirements of ISO/IEC 17021. This means all aspects of the
management and calibration processes were evaluated. This
evaluation includes traceability, measurement uncertainty (MU), use
of acceptable methods, environmental controls, results, reporting,
and many other factors. It also includes a complete review of the
management system of the laboratory. As a signatory of the ILAC
MRA, ACLASS can accept for calibration traceability only
laboratories that have been accredited by an MRA signatory
accreditation body. We trust that they have done as good a job as
we would in assessing a laboratory's capabilities.
What proof of traceability is
required during assessment?
During initial assessment and reassessment, assessors review
proof of "metrological traceability" for all standards listed on
the proposed or existing scope of accreditation. The easiest way to
demonstrate traceability is by producing a calibration certificate
issued by a national metrology institute, such as the National
Institute of Standards and Technology, or by a laboratory
accredited for that discipline by an accrediting body, such as
ACLASS, that is an International Laboratory Accreditation
Cooperation (ILAC) signatory. A list of ILAC signatories is
available from ILAC. If you can't find an NMI or accredited
source for the calibration, contact ACLASS for assistance.
Am I required to participate
in proficiency testing (PT) and/or inter-laboratory comparisons
(ILC)? How often and what are the costs? What if there are no
commercial PTs or ILCs available for me?
Unfortunately, there's a shortage of proficiency testing
programs available to accredited laboratories around the world. In
many cases, especially for testing labs, there is no reasonable PT
program available. Most accreditation bodies, including ACLASS,
require accredited labs to participate every year in some form of
PT or reasonable alternative if none is available. ACLASS must
approve the alternative. We also have a framework to approve any PT
program that is not commercially offered but might satisfy the PT
requirement for ACLASS-accredited labs. Costs can run from a few
hundred dollars to more than $1,000 for some programs and the
frequency of participation. We work with each lab on its PT
programs at each visit to make them increasingly value-added to
their QA and to building international confidence in their
demonstration of competence via PT/ILC.
What about NIST traceable v.
traceability to the SI Unit? Can I be traceable to another
country's NMI instead of NIST?
NIST traceable calibrations are often called ISO 9001
calibrations. In the ISO/IEC 17025 world, the term we should use is
metrological traceability, and the chain of comparisons is to the
SI unit, not any particular national metrology institute (NMI). The
vast majority of the global NMI's participate with each other in
comparisons to most of the highest precision measurements to
measure or "realize" many of the SI units or other indirect unit.
The participants recognize each other through these "key
comparisons," and thus the traceability chain can channel through
any one of them in most cases. This means that a lab in the United
States may have a very satisfactory metrological traceability for
some of their measurements that have no participation from NIST in
their chain of comparisons.