If you have any questions about the accreditation process, feel free to reach out to U.S. Accreditation at [email protected]. Alternatively, you can simply fill out the form on our "Get Accredited" page to initiate the process.
To initiate the accreditation process, the Conformity Assessment Body (CAB) completes and submits the application for accreditation, along with all required supporting documentation specified in the application form. The U.S. Accreditation staff then reviews the submitted application to ensure its completeness and proposes an assessor or assessment team based on the CAB's desired scope of accreditation. The CAB is notified of the proposed assessor or assessment team and is given their bios to confirm that there are no actual or potential conflicts of interest. Once the assessor or assessment team has been agreed upon, the application package is provided to them for further evaluation.
The lead assessor contacts the applicant to discuss scheduling the assessment and requests additional management system documentation to facilitate their document review, which is conducted prior to the assessment. CABs have the option to undergo a pre-assessment, during which the assessor identifies any areas not currently in compliance with the requirements before proceeding to the full assessment. This helps ensure a smoother and more efficient evaluation process.
During the full assessment, various activities are conducted, including an entry briefing, review of management system documentation and records, examination of sample handling processes, interviews with technicians, observation of tests being performed, and evaluation of technical records and reporting processes. At the conclusion of the assessment, a written assessment report is provided to the CAB, which includes any identified areas of non-conformance. This report is presented at the closing meeting, ensuring that the CAB is fully informed of the assessment outcomes and any necessary follow-up actions.
Following the assessment, the CAB addresses any cited non-conformities by providing U.S. Accreditation with a detailed corrective action response. U.S. Accreditation staff reviews this response for completeness and communicates with the CAB directly if further information is needed. Once the CAB's response is deemed complete, all assessment-related information is forwarded to a panel of the U.S. Accreditation Council for a vote. Accreditation is granted upon receiving affirmative votes from the Accreditation Council and after addressing any concerns raised by the Council. This process ensures that the CAB has successfully demonstrated compliance with the established accreditation criteria and is committed to maintaining high-quality standards.
On average, new applicants complete the accreditation process within five months, from start to finish. However, it is important to note that this timeframe is heavily dependent on the CAB's readiness, preparation, and responsiveness. A well-prepared CAB that actively engages in the process can significantly expedite the accreditation timeline.
Accreditation Process Flowchart
Typical Steps in Preparing for the Accreditation Process
This document outlines the various accreditation processes at U.S. Accreditation for all accreditation programs and fields, with the exception of specific programs or fields not covered herein. For detailed information on the accreditation process for those excluded programs or fields, please consult the relevant documentation or contact U.S. Accreditation directly for guidance.
Accreditation at U.S. Accreditation involves an annual activity that starts with an initial assessment, or in some cases, a pre-assessment. Once an organization achieves accreditation, it is referred to as a Conformity Assessment Body (CAB). Following the initial assessment, a two-year anniversary date is set, which also serves as the accreditation's expiration date.
At the mid-point of the initial accreditation cycle, the CAB is required to undergo a surveillance assessment (typically lasting one day) conducted by a U.S. Accreditation assessor. The purpose of this surveillance assessment is to verify that the CAB's management system has been fully implemented, corrective actions taken since the last assessment were effective, and the technical capabilities continue to comply with the accreditation requirements.
The renewal process is similar to the initial assessment process, with the exception that a surveillance assessment at the mid-point of the next accreditation cycle is typically not mandated. However, a mid-cycle surveillance assessment may be required if significant problems were noted during the last assessment that warrant follow-up, or if substantial issues have arisen since the last assessment that could call into question the organization's compliance with the accreditation requirements.
At the mid-point of subsequent assessment cycles, the CAB is required to submit updated information about its organization, facilities, key personnel, etc., along with specific quality system records requested through the U.S. Accreditation customer portal. The organization's assigned Accreditation Officer (AcO) will conduct a desk audit of this submitted information to ensure ongoing compliance with accreditation requirements.
Overall Accreditation Cycle:
- Initial Year (First Assessment)
- Year 1: Surveillance Assessment (typically one day)
- Year 2: Renewal Assessment
- Year 3: Annual Review (Desk audit)
- Year 4: Renewal Assessment
- Year 5: Annual Review (Desk Audit)
Note: Accreditation is a yearly activity. Renewal assessments are to be completed every 2 years with Annual reviews to be completed on the off years.
2. PREPARING FOR INITIAL ACCREDITATION
If at any point, while preparing for accreditation, you have questions or need further assistance please contact U.S. Accreditation using the contact us form found at https://accreditation.us/contact or email [email protected] directly.
1. Obtain an official copy of the conformity assessment standard(s) to which you are seeking accreditation to (e.g. ISO/IEC 17025, ISO/IEC 17020, etc.).
2. Review the applicable requirements documents for the areas in which you are seeking accreditation from the applicable pages on the U.S. Accreditation website. This will help to ensure a basic understanding of the accreditation process and the general criteria for accreditation. Please note that; your organization will be evaluated against these requirements during your assessment.
3. For additional information on the estimated cost of accreditation (i.e. applicable accreditation fees and assessment costs), complete the "Get Accredited" form that is linked from the U.S. Accreditation home page. In order for us to generate an accurate estimate, please provide a completed selection list or a draft scope of accreditation. Selection lists for various disciplines are located on our website at https://portal.accreditation.us/. Search for 'Selection Lists' and choose the form that is applicable to your program.
4. Create and implement a Management System with policies and procedures that meet the applicable conformity assessment standard and U.S. Accreditation requirements in the program for which you are seeking accreditation (e.g. ISO/IEC 17025, ISO/IEC 17020, etc.). Ensure that these documents fulfill the applicable requirements and that the personnel concerned are aware and accept the content.
5. Perform an internal audit to verify compliance with all U.S. Accreditation requirements, applicable conformity assessment standard requirements (e.g. ISO/IEC 17025, ISO/IEC 17020, etc.), the CAB’s own management system requirements and all applicable technical requirements and document the results of this audit. Discuss all relevant accreditation criteria thoroughly with those directly involved, identify the organization’s weak points and implement corrective actions where necessary. It is important to seek feedback from all applicable individuals to get the most comprehensive evaluation of the organization.
6. Perform a management review and document the results.
Where applicable, ensure that all supporting documents are translated into English prior to applying for accreditation. In most cases, all documentation must be provided in English and the assessment conducted in English. An appropriate English translation of pertinent documentation must be provided as well as a translator, if needed, to facilitate the assessment.
Please note any requested exceptions for assessments conducted in English on the submitted estimate https://accreditation.us/get-accredited, however, please note, that some documents (e.g. corrective action responses, etc.) must still be provided in English. U.S. Accreditation staff will provide further details as appropriate, upon request.
7. Identify an individual as the “U.S. Accreditation authorized representative” to assume responsibility for upholding the accreditation requirements and for making them available to relevant staff and applicable resources. This individual shall have binding authority from your organization to enter into the accreditation agreement with U.S. Accreditation.
8. The application can be accessed from U.S. Accreditation website, by clicking on the "Get Accredited" link at the top of the page or using this link: https://accreditation.us/get-accredited
9. U.S. Accreditation will process your application within 2 business days and you will be notified via email of your assigned U.S. Accreditation Staff Person with the necessary login information to access the Customer Portal. In the portal, you will need to upload supporting documentation that will be required to complete this portion of the application. All applicable documentation (including full text checklist(s)) specific to your area(s) of accreditation, DRAFT scope(s) of accreditation, open invoices and the ability to make credit card or eCheck payments, as well as, a means to track open assessments and annual reviews are accessible from your Customer Portal. Please note that an application will not be deemed complete until all supporting information is received.
10. U.S. Accreditation will notify you through the Customer Portal of the name(s) of the selected assessor(s) and provide a brief biography. If you have justifiable objections (e.g. conflicts of interest) to the proposed assessor(s), changes in the assignment(s) may be made.
11. The lead assessor will contact you directly to schedule the initial assessment.
3. OPTIONAL PRE-ASSESSMENT
1. U.S. Accreditation does offer the option of having a pre-assessment. A pre-assessment provides an opportunity for the organization to evaluate its preparedness for the initial assessment. In most cases the same (lead) assessor assigned to perform the initial assessment will perform the pre-assessment. The assessor will usually spend a day assessingthe facility evaluating the management system. This is an opportunity to identify areas of possible non-compliance before a full assessment is performed.
2. During this pre-assessment, the management system will be assessed for implementation and compliance with the applicable conformity assessment standard as well as the applicable U.S. Accreditation requirements. If requested, a sampling of technical activities may also be evaluated. Note that the U.S. Accreditation assessor is not permitted to provide consulting services during this assessment.
3. When the CAB feels that they have addressed the items noted during the pre-assessment they should contact their AcO to proceed with the initial assessment as described above.
4. PREPARING FOR SURVEILLANCE ASSESSMENT
1. Your organization will be required to undergo a surveillance assessment. This is typically a one-day assessment to confirm implementation of the management system. Reaffirmation of accreditation to the established anniversary date will be based upon having the surveillance assessment, U.S. Accreditation’s receipt of the appropriate final payment of fees, and resolution of all (where applicable) deficiencies cited during the surveillance.
2. The surveillance assessment will be initiated 6 months prior to the midpoint of your initial accreditation cycle. When you are alerted that the surveillance assessment has been generated you will log on to your designated Customer Portal, confirm your CAB information, and agree to abide by the U.S. Accreditation – Conditions for Accreditation.
3. Upload an up-to-date organization chart identifying by name, the key personnel involved for each function. Highlight any changes since the initial U.S. Accreditation assessment. If your organization is part of a larger organization, provide the organizational chart of that organization and identify reporting relationships within that organization.
4. Upload the applicable, requested documentation via your Customer Portal.
5. An assessor (usually the same person who performed your initial assessment, where practicable) will be proposed to your organization upon receipt of the aforementioned documents. The assessor will schedule and perform the surveillance assessment.
5. PREPARING FOR ANNUAL REVIEW OF ACCREDITATION
1. Annual reviews occur during the midpoint of each 2-year renewal accreditation cycle. This process is initiated 3 months prior to the midpoint of your renewal accreditation cycle. Once alerted that the annual review of accreditation has been initiated, log on to your designated Customer Portal, confirm your CAB information, agree to abide by the U.S. Accreditation – Conditions for Accreditation, upload the required Annual Review Supporting Information, and submit payment.
2. Upload an up-to-date organization chart identifying by name, the key personnel involved for each function. Highlight any changes since the last U.S. Accreditation assessment. If your organization is part of a larger organization, provide the organizational chart of that organization and identify reporting relationships within that organization.
3. Upload the results of your most recent internal audit and management review and any further documents that are requested via the Customer Portal.
Please Note: The annual review documentation must be submitted by the designated due date (assigned by U.S. Accreditation and communicated to each CAB through the Customer Portal) or remedial action could occur. Please do not hold up submission of the required annual review documentation if certain functions (e.g. the internal audit, management review, etc.) are scheduled for a timeframe after the required annual review submission date. Please submit the most recent complete set of records.
4. Once all the appropriate information is provided and payment is received, U.S. Accreditation will reaffirm the accreditation of your organization.
6. PREPARING FOR RENEWAL OF ACCREDITATION
1. The renewal of accreditation process is initiated 6 months prior to the expiration date of your current accreditation. Once the assessment has been generated you will log on to your Customer Portal, confirm your CAB information, and agree to abide by the U.S. Accreditation – Conditions for Accreditation.
2. Review the applicable requirements documents that are readily located on your Customer Portal, and also from the U.S. Accreditation website at accreditation.us. Please note that your organization will be evaluated against these requirements during your assessment.
3. Upload an up-to-date organization chart identifying by name, the key personnel involved for each function. Highlight any changes since the last U.S. Accreditation assessment. If your organization is part of a larger organization, provide the organizational chart of that organization and identify reporting relationships within that organization.
4. Complete and upload the applicable conformity assessment checklist(s) (located on your Customer Portal https://portal.accreditation.us).
5. Upload an uncontrolled copy of your current management system documentation that is referenced in the completed assessor checklist(s) (e.g. operating procedures, work instructions, etc.).
6. Upon receipt of all the necessary documentation U.S. Accreditation will notify you through the Customer Portal of the name(s) of the selected assessor(s) and provide a brief biosketch. If you have justifiable objections to the proposed assessor(s), changes in the assignment(s) may be made.
7. The assessor schedules and performs the renewal assessment.