FAQ

In general, a well-prepared applicant can complete the accreditation process in three to six months. If you have a specific timeline or a crucial deadline to meet, please let your accreditation officer and assessor know. Every effort will be made to accomodate your needs. Applicant readiness is the most important factor in determining the time it will take to obtain INTERAS accreditation. Applicants who have taken the time to prepare for assessments and who respond quickly to assessment deficiencies can complete the process in a timely manner.

Delays in the accreditation process are most frequently related to:

• Incomplete application packages
• Measurement uncertainty budget issues
• Delays in responding to deficiencies

Terms such as “quality system registration” or “audit to the intent of” convey a process of verifying that the organization in question is following a documented quality management system in accordance with the quality system elements of standards (e.g. ISO 9

All INTERAS staff, assessors, and technical experts involved in the assessment and accreditation process must sign a conflict of interest and confidentiality policy to ensure that the confidentiality of our customers is maintained.

All information in relation to a customer’s application is kept in strictest confidence and may only be released under written approval by the customer. In cases where review by a broader audience is required, documents are stripped of any identification of the organization or excerpts are taken to ensure confidentiality.

The most important factor in determining the number of assessors that will be assigned is the size and breadth of the proposed Scope of Accreditation.

For example, if a conformity assessment body (CAB) is seeking accreditation for only one field of testing, one calibration discipline, or a single area of inspection, usually one assessor will suffice.

If the CAB is seeking accreditation in multiple fields of testing, multiple calibration disciplines, or multiple conformity assessment standards, multiple technical experts may be needed to cover all the tests, types of tests, calibrations, inspections, etc. that are being proposed for the Scope(s).

Other factors include the size of the facility and the level of measurements being made (especially in calibration).

Each decision is handled on a case-by-case basis after careful review of the application and the desired Scope(s) of Accreditation.

You can discuss the number of assessors being assigned in more detail with your assigned Accreditation Officer (AcO).

Exceptions to the INTERAS Traceability Policy can be made for Measuring and Test Equipment (M&TE) for which an acceptable accredited source of calibration is not currently available or when an acceptable accredited source of calibration is currently available but special circumstances regarding the nature of the calibration precludes the laboratory from obtaining an accredited calibration. These exceptions are evaluated on a case-by-case basis and require that the organization seeking an exception maintain documentation to support traceability of the calibration results received from the unaccredited provider.

An acceptable accredited source includes recognized National Metrology Institutes, such as NIST, and calibration laboratories accredited by INTERAS or one of our mutual recognition partners.

Yes, however, under INTERAS’s multilateral recognition arrangement (MRA) obligations in the Global Accreditation Cooperation Incorporated (Global ACI) community and the rules governing international commerce, INTERAS must encourage international organizations to pursue accreditation with accreditation bodies in their local economies wherever possible. If you can demonstrate that local accreditation bodies cannot meet your needs for whatever reason, INTERAS can accredit your organization. Global ACI full-member (MRA Signatory) organizations may be found at the Global ACI website.

Please note that all document submissions to INTERAS must be in English. For international customers, we will work to the best of our ability to find an assessor local to you who is fluent in your language.

International travel by INTERAS assessors may be limited at certain times or to certain locations due to travel advisories, safety concerns, or other factors beyond our control.

The CMC is normally stated numerically, but where the CMC is a function of the quantity to which it refers (or any other parameter), it should be given in the form of an equation. For example, the dominant uncertainty contributor for calipers is often resolution. In these cases, the best way to represent uncertainty is as a function of the resolution (e.g., U = 0.6R) where “R” is the resolution in microinches. Similarly, gage blocks often quantify uncertainty based on length (e.g., U = 4 + 3L) where “L” is the length of the block in inches.

The following is taken from ILAC-P14:11/2010 “ILAC Policy for Uncertainty in Calibration”:

In the context of the CIPM MRA and ILAC Arrangement, and in compliance with the CIPM-ILAC Common Statement, the following definition is agreed upon:

A CMC is a calibration and measurement capability available to customers under normal conditions:

• As described in the laboratory’s scope of accreditation granted by a signatory to the ILAC Arrangement; or
• As published in the BIPM key comparison database (KCDB) of the CIPM MRA.

The following is adapted from ILAC-P14:09/2020 ILAC Policy for Uncertainty in Calibration:

The term “best existing device” is defined as a device to be calibrated that is commercially or otherwise available for customers, even if it has a special performance (stability) or has a long history of calibration.

In exceptional instances, it is recognized that a “best existing device” does not exist and/or contributions to the uncertainty attributed to the device may significantly affect the uncertainty. If such contributions to uncertainty from the device can be separated from other contributions, then the contributions from the device may be excluded from the CMC statement. For such a case, however, the scope of accreditation shall clearly identify that the contributions to the uncertainty from the device are not included.

Example: “The contributions from the ‘best existing device’ are not included in the CMC claim.”

In general, no. CMCs are usually calculated based on optimistic (but realistic) estimates of the uncertainty contributors. Unless the conditions of an actual calibration match the assumptions used to estimate the CMC, the calibration uncertainty will generally be larger than the CMC.

The uncertainty of reported measurements has to be stated as the actual uncertainty of the measurement, not as the accredited CMC unless that CMC actually applies. An indiscriminate use of the CMC as the uncertainty of an actual calibration is not justified.

On the other hand, some calibration labs will calculate CMCs based on the worst conditions that they’re likely to see. In these cases, the CMC on the scope of accreditation will be large enough to cover all of those conditions. This is why some labs quote their accredited CMCs for most of their work. Although this method is acceptable, it has the disadvantage that it doesn’t allow the lab to quote a smaller uncertainty if a calibration is performed under conditions better than were assumed for the scope of accreditation.

The definition of Calibration and Measurement Capability (CMC) implies that, within its accreditation, a laboratory is not entitled to claim a smaller uncertainty of measurement than the CMC. This means that the laboratory shall be required to state a larger uncertainty than that corresponding to the CMC whenever it is established that the actual calibration process adds significantly to the uncertainty of measurement. Typically, the equipment under calibration may give a contribution. The actual uncertainty of measurement can never be smaller than the CMC.

No. Contributions to the uncertainty stated on the calibration certificate shall include contributions that can reasonably be attributed to the customer’s device. The exclusion option only applies for the uncertainty calculation that supports the calibration and measurement capabilities (CMCs) on the Scope of Accreditation.

ISO 15189 is an internationally-recognized standard, with over 40 ILAC-recognized accreditation bodies offering ISO 15189 accreditation programs. In some countries it is the standard by which laboratories are reimbursed. Although ISO 15189 is not mandatory in the U.S., an increasing number of clinical labs have recognized the benefit of being accredited by an internationally-recognized accreditation body (such as INTERAS) along with their CLIA accreditation.

Similar to how you expect your customers to select a laboratory based upon their qualifications and credentials, so should you when choosing an ISO 15189 accreditor. Anyone can self-declare competence in offering ISO 15189 accreditations, but you need to ask yourself: “What are their credentials and who has accredited them?” When it comes to INTERAS, the answer is easy. INTERAS’s over 45 years of experience in accrediting specifically to ISO standards and our signatory status within the ILAC MRA for the accreditation of clinical laboratories to ISO 15189 speak for themselves. Our technical expertise is second-to-none as is our experience with management systems and ISO standards. We not only accredit laboratories to these standards, but we are expert enough in their development and implementation to train others in how to utilize them to better their laboratory’s performance.

ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

INTERAS assigns assessors with the education and expertise to complement a laboratory’s desired Scope of Accreditation. All of our clinical assessors have extensive experience in assessing CLIA laboratories and have been found to meet INTERAS’s stringent requirements for being contracted members of our assessor corps. A lead assessor is assigned as are additional assessors depending on the extensiveness of the laboratory’s desired Scope of Accreditation. The time spent on-site by our assessors is not only commensurate with the desired Scope and but also takes into account the time necessary for a thorough review of the laboratory’s management system. All of our assessors, while undeniably technical experts, also undergo extensive training on the assessment of all QMS elements. INTERAS approaches this training as an ongoing investment to ensure the high caliber of our assessor corps. All assessors are observed and evaluated performing actual assessments and this evaluation process occurs at regular intervals throughout the term of their contract with INTERAS, ensuring a continual level of consistency and expertise.

Absolutely. A peer evaluation team is selected to cover all areas for which an accreditor is seeking recognition under the ILAC MRA. Therefore, each team selected to evaluate INTERAS includes at least one member with internationally-recognized expertise in the clinical field. This individual then systematically examines all aspects of the INTERAS clinical laboratory accreditation program, including observation of one or more actual INTERAS on-site assessments of a clinical laboratory to ISO 15189.

For more information about ILAC, peer evaluation, and INTERAS’s formal recognitions, see the “About INTERAS” category of the FAQ.

Assessor teams are selected based upon a laboratory’s desired Scope of Accreditation.

ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

ISO/IEC 17025 incorporates the essential elements of ISO 9001 and adds technical competency underpinnings relevant to testing and calibration laboratories. Its primary application is to improve the management and techni­cal structure of testing and calibration laboratories. ISO/IEC 17025 accreditation (as opposed to ISO 9001 registration) includes both an assessment of the Management System and an evaluation of the technical competency of the testing and/or calibration laboratories.

ISO 9001 is a registration of a quality management system and serves as the basis for many of the other ISO standards because of its intentional generalness.

ISO/IEC 17020 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to inspection bodies. Its primary application is to improve the management and techni­cal structure of inspection bodies. ISO/IEC 17020 accreditation (as opposed to ISO 9001 registration) includes both an assessment of the Management System and an evaluation of the technical competency of the Inspection Body.

INTERAS serves the forensic community through attendance and presentations at meetings and through participation on committees and commissions.

INTERAS staff maintain memberships with numerous forensic associations including the Association of Forensic Quality Assurance Managers (AFQAM), ASTM Committee E30 on Forensic Sciences, OSAC Quality Task Group and Seized Drugs Subcommittee, Scientific Working Group on Digital Evidence (SWGDE), ILAC AIC Working Group 10, NFPA Fire Investigation Units (FIU) Committee, the International Association for Identification (IAI), and the Maryland Forensic Laboratory Advisory Committee (FLAC).

INTERAS contracted assessors maintain memberships with ASTM forensic committees and forensic scientific working groups (SWGs) as well as continuing to work in their respective fields.

All INTERAS staff, assessors, and technical experts involved in the assessment and accreditation process must sign a conflict of interest and confidentiality policy to ensure that the confidentiality of our customers is maintained.

All information in relation to a customer’s application is kept in strictest confidence and may only be released under written approval by the customer. In cases where review by a broader audience is required, documents are stripped of any identification of the organization or excerpts are taken to ensure confidentiality.

All assessment documentation is housed in INTERAS’s secure, NIST-compliant database.

The organization as a whole is required to meet INTERAS R103 – General Requirements – Proficiency Testing for ISO/IEC 17025 Laboratories. R103 requires organizations to participate in external PT where available and appropriate. Individual analysts/examiners; however, are not subject to R103’s external PT requirement. Instead, INTERAS R221 and R318 each have separate monitoring requirements for personnel that reference the participation of either commercial PT, intralaboratory comparisons, OR interlaboratory comparisons annually for each discipline in which they are authorized. All authorized sub-disciplines shall be covered in a four-year period.

INTERAS does not charge fees for such activities. However, if review by a technical assessor or an on-site assessment is needed to confirm the continued compliance of your facility, you may be invoiced for the assessor’s time and travel expenses. In such cases, INTERAS would notify you in advance of any potential cost to you before moving forward.