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FAQ

Frequently Asked Questions

About ANAB

Recognition

Accreditation Process for Laboratory-related Programs

Technical Questions Related to Accreditation for Laboratory-related Programs

Questions Related to Management Systems Accreditation

About ANAB

What is ANSI-ASQ National Accreditation Board?

The ANSI-ASQ National Accreditation Board is a non-governmental organization that provides accreditation services to public- and private-sector organizations. ANAB is jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ).

Why should I use the services of ANAB?

ANAB 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.

Under what authority does ANAB operate?

ANAB is a Wisconsin limited liability corporation operating under an agreement between the American National Standards Institute (ANSI) and the American Society for Quality (ASQ), both of which are New York nonprofit corporations.

ANAB operations are in keeping with U.S. government support for use of standards and conformity assessment solutions developed or adopted by private, voluntary consensus standards bodies in lieu of developing government-unique standards or regulations (per the National Technology Transfer and Advancement Act of 1995, Public Law 104-113). ANAB operations are also consistent with the government's endorsement of close interaction and cooperation between the public and private sectors as critical to developing and using standards that serve national needs and support innovation and competitiveness (per the Office of Management and Budget a-119: Federal Participation in the Development and Use of Voluntary Consensus Standards in Conformity Assessment Activities).

ANSI, one of the owners of ANAB, is the U.S. body to the International Organization for Standardization (ISO). ANAB's board of directors and Accreditation Council are composed of representatives of stakeholders of ANAB programs, including government.

Who oversees ANAB's work?

ANAB complies with international standards and requirements for accreditation bodies and is a member of the International Accreditation Forum (IAF) and the InterAmerican Accreditation Cooperation (IAAC). ANAB is signatory of the IAF and IAAC multilateral cooperative arrangements (MLAs) for QMS and EMS. IAF and IAAC members are admitted to the MLAs after a stringent assessment of their operations by a peer evaluation team charged to ensure full compliance with international standards and IAF and IAAC requirements. MLA signatories are required to recognize the certificates issued by certification bodies accredited by all other signatories of the MLAs.

Through the IAF, ILAC, IAAC, and APLAC MRAs/MLAs and the Multilateral Cooperative Accreditation Arrangement, ANAB cooperates with other accreditation bodies around the world to provide value to its accredited customers and their customers, ensuring that accredited certificates are recognized nationally and internationally. The global conformity assessment system ensures confidence and reduces risk for customers engaging in trade worldwide.

How is ANAB financially supported?

ANAB is supported by fees charged for its accreditation services. ANAB receives no funding from ASQ or ANSI.

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.

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

ANAB is jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ). ANAB is the U.S. accreditation body for management systems (for example, ISO 9001) certification bodies, and provides accreditation for ISO/IEC 17025 forensic test agencies and ISO/IEC 17020 forensic inspection agencies, 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. ANAB 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, ANAB 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.

Recognition

Is ANAB recognized domestically and internationally?

ANAB is a signatory of the multilateral recognition arrangements (MRAs) of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). ANAB is also a signatory of the Inter-American Accreditation Cooperation (IAAC) multilateral recognition arrangement (MLA). Domestically, ANAB 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 ANAB demonstrate its capability as an accreditation body?

ANAB, 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 ANAB 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 for Laboratory-related Programs

How do I start the accreditation process?

Call ANAB at 877-344-3044, ext. 202, 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 ANAB 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 ANAB customers?

ANAB 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 for laboratory-related programs?

For laboratory-related programs, 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 for laboratory-related programs?

At the end of the accreditation assessment, you'll receive a copy of the assessor checklist and any nonconformities. The assessor will tell you prior to leaving the facility if your company will be recommended for accreditation. After corrective action responses are approved, ANAB 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 laboratory 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 ANAB Guidance Document on Scopes of Accreditation.

Are all ANAB 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. ANAB 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 ANAB accreditation?

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

Technical Questions Related to Accreditation for Laboratory-related Programs

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.

ANAB has an easy to understand guidance documents on uncertainty 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 MA 2002 or contact your Accreditation Manager.

Does ANAB 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?

ANAB 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 ANAB when they are available. If no results have been received within six months of accreditation, the accredited laboratory is subject to suspension until ANAB 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, ANAB 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, ANAB 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 ANAB, 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 ANAB 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 ANAB, require accredited labs to participate every year in some form of PT or reasonable alternative if none is available. ANAB 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 ANAB-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.

Questions Related to Management Systems Accreditation

What is certification?

Certification is the act of verifying the conformance to a standard or other requirements. A certification body audits an organization and, if appropriate, a certificate of conformance to a given standard (for example, ISO 9001 for quality management systems) is issued. With regard to management systems, the terms certification and registration are used interchangeably. (Certification also refers to the process of validating and verifying the credentials of individuals, such as auditors.)

What is a certification body (CB)?

A CB (also known as a registrar) is a third-party company contracted to evaluate the conformance of an organization to the requirements of the appropriate standard(s) and issue a certificate of conformance when warranted.

What are the benefits of management systems certification?

Benefits of implementing quality management systems include increased operational efficiency; an opportunity to critically examine how employees do their work and interact between functions; establishing the proper processes for future operations; better documentation of methods and responsibilities; consistency of process; greater employee awareness about quality; cost savings from less scrap and rework, as well as fewer warranty claims; enhanced communication among employees; customer satisfaction; competitive edge; increased credibility; ease of trade; perceived higher quality; reduced customer audits; increased market share; and fulfilling supplier requirements for certification.

Benefits of implementing environmental management systems include potential reduction in process by-products and wastes ; greater employee awareness about the environment and the impact of their jobs on it; potential increased energy efficiency and energy conservation in design, production, and postproduction processes; creation of systematic structure for complying with environmental regulations; customer satisfaction/requirement; competitive advantage; ease of trade, avoiding non-tariff trade barriers; potential for improved market share; and improved image with community and environmental groups.

Implementing other management systems may offer some of the same benefits, as well as benefits unique to the specified type of management system.

What is accreditation?

Accreditation is the means by which an authoritative body (such as ANAB) gives formal recognition that an organization (such as a CB) is competent to carry out specific tasks. Accreditation provides assurance to a CB's customers that the CB continues to operate according to internationally accepted criteria.

Accreditation is used to validate or verify the conformance of a certification body to the requirements of national and/or international criteria.

An accreditation body is an organization that grants the authority to issue certificates to the certification body. An accredited certification body is an organization assessed and recognized by an accrediting body for its competence to audit and issue (and withdraw) certification attesting that an organization, product, or person meets the requirements of a standard or other requirements.

An organization considering certification rightfully wants to know about the reputation and competence of the CB it selects. The organization wants assurance that the CB is competent to evaluate its systems and that their customers will value the CB's judgment, no matter where their customers are located. Each country is responsible for devising its own system for providing such assurance through the process of accreditation. In many countries, the job is vested in a single accreditation body, often a government agency. In the United States, that body is ANAB for management systems.

How can I obtain a list of ANAB-accredited management systems CBs?

This site contains a searchable directory of accredited management systems CBs. You can search the directory by CB name, location, scope category (for QMS), and other qualifications.

How does ANAB determine whether a management systems CB meets ANAB's accreditation criteria?

ANAB accreditation assessors evaluate a prospective CB's written policies and procedures, including the credentials of its auditors. If all of these are acceptable, the ANAB assessor team performs a rigorous on-site examination of the CB's internal operations and then witnesses the CB conducting a complete client audit.

How often are accredited management systems CBs re-examined?

Accreditations are valid for four years. Continuance of accreditation (surveillance) includes an annual office assessment and an annual witnessed audit. a complete reassessment is required every four years. Increased surveillance may required performed if the CB wishes to extend the scope of accreditation to cover additional industry sectors or to participate in certain specialty fields.

What should I do if I believe that an ANAB-accredited management systems CB has not done an adequate job?

Each management systems CB is required to have a system for handling complaints. ANAB evaluates the operation of the complaint system during its surveillance. Every CB also has an appeals system through which clients can appeal adverse decisions. The CB's appeals system is also evaluated by ANAB during surveillance.

If you have a complaint, please go to ANAB's online complaint center.

How can my organization become an ANAB-accredited management systems CB?

There is information about applications on this website. While ANAB accepts applications from CBs based outside of North America, ANAB encourages such CBs to seek accreditation by their local national accreditation body.

What is the certification process for management systems?

Certification is done by a CB through a series of document reviews and facility visits and audits. The CB's auditors examine an organization's procedures, processes, and operations to determine their conformance to the requirements (elements) of the standard.

The CB evaluates a variety of issues. For QMS certification, these include but are not limited to the applicant organization's administrative, design, and production processes; quality system documentation; personnel training records; management reviews; and internal audit processes. For EMS certification, these include but are not limited to the applicant organization's administrative processes; technical capabilities and operations; training and experience of personnel; regulatory compliance; environmental aspects and impacts; and management review and internal audit processes.

The certification process can take anywhere from several weeks to more than a year, depending on the readiness of the organization applying for certification. Other factors that can contribute to the amount of time certification takes are the size of the organization, the scope of the certification, and the number of facilities being certified and their location.

What is a pre-assessment?

Pre-assessment is an option offered by most CBs to help an organization determine its readiness for the certification audit. Other terms for pre-assessment are pre-audit and trial audit. Pre-assessments offer the opportunity for a "no-risk-of-failure" audit and the experience of a third-party audit.

During a pre-assessment, the audit team evaluates all applicable management systems elements for approach, implementation, and the amount of evidence available. Audit findings are limited to weak implementation or failure to address an element or requirement. These are described in a written pre-assessment report; formal nonconformance reports may not be issued.

Accredited CBs are not permitted to offer advice on how to resolve nonconformances, as this would be considered consulting. Accredited CBs are not allowed to offer certification and consulting together. ANAB limits the number and frequency of pre-assessments to prevent the perception of consulting or advice giving.

Who does a CB interview during the course of the certification process?

a CB's audit team can interview anyone from the chief executive officer to line workers and operators. This interview process is typically done on a sampling basis and covers a wide range of personnel from diverse divisions and departments.

How helpful may a management systems CB be to the success of an organization's certification effort?

a management systems CB may not engage in advice-giving or consulting with the organization it is certifying. One of the conditions of accreditation is that certification and consulting may not be marketed together, nor may it be said or implied that certification may be easier as a result of using the services of a particular consultant. Persons engaged in both certification assessment and consulting for the same organization must separate these activities by at least two years of time. ANAB considers private or tailored training to be consulting if it is offered by a CB (or related body) to an organization being certified.

How much does management systems certification cost?

The cost depends on a variety of factors including but not limited to the amount of time that the process takes, which is based in part on the size of the organization, the scope of the certification, and the number of facilities being certified and their location. Other factors may also come into play. For example, whether an organization seeking ISO 14001 certification already has an ISO 9001 system in place and whether that system is registered may have an impact on the cost.

Must management systems certification be periodically renewed?

Yes. The process includes annual surveillance audits and a periodic re-assessment. The two most common processes for surveillance audits are one surveillance audit annually or two surveillance audits annually at approximately six-month intervals. The total number of audits days annually is usually the same in either case, as this is established by IAF Guidance, and should total about one-third of the days required for the initial audit.

a re-assessment audit is also required. Normally this occurs in the third year of a certification cycle, with an audit duration of about two-thirds the number of days required for the initial audit; this is also established by IAF Guidance.

IAF guidance allows flexibility in the frequency of the audits and audit duration. The CB is responsible for assuring that the surveillance and re-assessment program is sufficient to verify continued conformance of a certified organization. ANAB requires the CB to have documented justification for any variation from the surveillance and re-assessment audit frequency and duration specified in the IAF Guidance.

It's important to note that some CBs issue certificates for three years with an expiration date. Others do not include an expiration date on the certificate and it is considered valid unless withdrawn. Both of these are acceptable options. In all cases with either system, if there is any question about the validity of a current certificate, one should contact the CB directly.

What happens if a CB finds nonconformities at a facility during the management systems certification audit?

It's important to note that there are several degrees of nonconformities, or NCRs. Typically, these are minor and major NCRs, and possibly also observations.

An observation is just that: an observation. Not a violation of the criteria, an observation is typically an identification that there may be a better way to monitor a process or document a procedure. It's not a problem, just a potential for improvement - a way to avoid future problems.

a minor nonconformance by itself doesn't indicate a systemic problem with the management system. It is typically an isolated or random incident. An example would be not having the most current version of a document available at an operator's station; the updated version exists but a copy of it is not available for the operator's use and the operator is using an outdated procedure. Other examples are a form without a document control number on it, a micrometer that is out of calibration, and an internal audit finding with an overdue corrective action request pending.

a major nonconformance occurs when one of the criteria of the standard has not been addressed or has not been addressed adequately. Typically, major NCRs occur when an organization has not addressed all of the requirements of a specific element or criterion. They also occur when an organization has put a process or procedure in place but has not implemented it or cannot yet demonstrate effective implementation.

a major nonconformance can also occur if a significant number of minor NCRs in a given activity or against a given element point to a systemic failure. For example, a minor nonconformance in document control may not in itself constitute a significant problem. But if several problems (the audit team leader judges what constitutes a significant number) are found with document control, then this points to a larger systemic document control problem and would constitute a major nonconformance.

If the CB discovers a regulatory noncompliance during an EMS certification audit, does the organization fail the audit?

a regulatory noncompliance won't necessarily result in failing the certification audit. CBs recognize that all facilities will be out of regulatory compliance at one time or another. The CB's audit team will look at how an organization handled the situation. Did the system identify how to address the noncompliance? Was it reported quickly and properly? Was a root-cause analysis done to prevent future violations? How the environmental management system responded to the noncompliance will determine whether an organization passes the certification audit.

What is IAAR?

The Independent Association of Accredited Registrars (IAAR) is an association of accredited management systems CBs operating in North America. IAAR actively promotes the establishment and maintenance of effective management systems in companies through the use of accredited certification. ANAB representatives play an active role in IAAR activities.