ACLASS Frequently Asked Questions

About the ANSI-ASQ National Accreditation Board

What is ANSI-ASQ National Accreditation Board?

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 Quality (ASQ).

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?

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 by ACLASS?

These are just some of the organizations accredited by ACLASS:

Agilent Technologies	NASA Johnson Space Center
American Type Culture Collection (ATTC)	Nano Measurements
Avianca Airlines	National Insitute of Health, Peru
Boston Scientific	Sartorius
Browne and Sharpe/Hexagon Metrology (Romer, Sheffield)	SGS
Caterpillar	Standards Institute of Israel
Columbia Food Labs	STR
General Electric	Sypris Test & Measurement
Horiba	Tektronix
IEH	Thermo Fisher Scientific
Intertek	Tyco Corporation
Johnson Diversey	U.S. Army
Kistler Instruments	USDA
Lockheed Martin (including Stennis Space Center)	U.S. Pharmacopeia

How are ACLASS, ANSI, ANAB, and ASQ related, and what's the history behind the company name?

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 verifiers.

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 1991.

Recognition

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 organizations.

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.

Accreditation Process

How do I start the accreditation process?

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 website.

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 started.

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 assessment?

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 accreditation established?

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 accreditation?

ACLASS provides a letter stating that accreditation is in progress so your customers understand you're working to become accredited.

Technical Questions

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 website.

Why is it important to use accredited laboratories for calibration of standards?

ISO/IEC 17025 Section 5.6.2.1.1 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 5.10.4.2).

"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 Manager.

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 verified.

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 measurement uncertainty?

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 continuing requirements?

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 accreditation?

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. Why?

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.