A PPLICATION FOR ONC-AUTHORIZED TESTING & CERTIFICATION BODY (ONC-ATCB) STATUS: PART I
Please complete all sections of the application form and submit the completed application and requested supporting documentation to the National Coordinator for Health Information Technology.
A complete Part I of the application will include the following components:
Application Components for Part I |
Action Required |
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General Identifying Information |
Provide Information |
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Designated Point of Contact for ONC-ATCB Applicant |
Provide Information |
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ISO/IEC 17025:2005 Self-Audit Conformance Checklist |
Complete Self-Audit |
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Proof of Conformance to ISO/IEC 17025:2005 |
Document Conformance |
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ISO/IEC Guide 65:1996 Self-Audit Conformance Checklist |
Complete Self-Audit |
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Proof of Conformance to ISO/IEC Guide 65:1996 |
Document Conformance |
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Agreement to Adhere to the Principles of Proper Conduct for ONC-ATCBs |
Sign Original Agreement |
For electronic submissions, applicants must return a completed application, including all documents, in PDF to ATCBapplication@hhs.gov.
If submitting the completed application form by e-mail, please include the applicant’s name and the date in the subject line. In addition, in the body of the mail, please include a list of the names of all the attachments submitted with the e-mail, indicating to which application requirement each attachment applies. All supporting documents must be clearly labeled with a document title and the organization name.
Paper applications must be submitted to the following address. Two (2) copies of submitted documentation are required for postal mail submission.
Office of the National Coordinator for Health Information Technology
Attention: Certification Programs
Hubert H. Humphrey Building, Suite 729D
200 Independence Ave, S.W., Washington, D.C. 20201
Please review all information contained within the application form carefully before submission.
For inquiries and questions about the application process or how to complete the application form, please contact the Office of the National Coordinator for Health Information Technology:
Office of the National Coordinator for Health Information Technology
Attention: Certification Programs
Hubert H. Humphrey Building, Suite 729D
200 Independence Ave, S.W., Washington, D.C. 20201
Phone: (202) 690-7151
E-mail: ATCBapplication@hhs.gov (Application Questions)
Email: ONC.Certification@hhs.gov (General Questions)
Applicant Name(s):
Address:
City, State: Zip Code:
Homepage URL:
Name (Last, First): Title:
Phone: Cell:
E-mail:
ISO/IEC 17025:2005 Self-Audit Conformance Checklist
Please check each box as appropriate. If you believe that a particular requirement of ISO 17025 does not apply to your application for authorization as an ONC-ATCB, please clearly identify the requirement and attach a detailed explanation for why the requirement should not apply.
Management Requirements |
Section 4 |
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Organization |
Section 4.1 |
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Management System |
Section 4.2 |
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Document Control |
Section 4.3 |
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General |
Section 4.3.1 |
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Document approval and issue |
Section 4.3.2 |
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Document changes |
Section 4.3.3 |
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Review of requests, tenders and contracts |
Section 4.4 |
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Subcontracting of tests and calibrations |
Section 4.5 |
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Purchasing services and supplies |
Section 4.6 |
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Service to the customer |
Section 4.7 |
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Complaints |
Section 4.8 |
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Control of nonconforming testing and/or calibration work |
Section 4.9 |
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Improvement |
Section 4.10 |
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Corrective action |
Section 4.11 |
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General |
Section 4.11.1 |
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Cause analysis |
Section 4.11.2 |
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Selection and implementation of corrective actions |
Section 4.11.3 |
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Monitoring of corrective actions |
Section 4.11.4 |
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Additional audits |
Section 4.11.5 |
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Preventive action |
Section 4.12 |
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Control of records |
Section 4.13 |
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General |
Section 4.13.1 |
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Technical records |
Section 4.13.2 |
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Internal audits |
Section 4.14 |
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Management reviews |
Section 4.15 |
Technical Requirements |
Section 5 |
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General |
Section 5.1 |
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Personnel |
Section 5.2 |
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Accommodation and environmental conditions |
Section 5.3 |
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Test and calibration methods and method validation |
Section 5.4 |
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General |
Section 5.4.1 |
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Selection of methods |
Section 5.4.2 |
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Laboratory-developed methods |
Section 5.4.3 |
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Non-standard methods |
Section 5.4.4 |
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Validation of methods |
Section 5.4.5 |
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Estimation of uncertainty of measurement |
Section 5.4.6 |
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Control of data |
Section 5.4.7 |
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Equipment |
Section 5.5 |
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Measurement traceability |
Section 5.6 |
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General |
Section 5.6.1 |
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Specific Requirements |
Section 5.6.2 |
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Reference standards and reference materials |
Section 5.6.3 |
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Sampling |
Section 5.7 |
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Handling of test and calibration items |
Section 5.8 |
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Assuring the quality of test and calibration results |
Section 5.9 |
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General |
Section 5.10.1 |
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Test reports and calibration certificates |
Section 5.10.2 |
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Test report |
Section 5.10.3 |
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Calibration certificates |
Section 5.10.4 |
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Opinions and interpretations |
Section 5.10.5 |
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Testing and calibration results obtained from subcontractors |
Section 5.10.6 |
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Electronic transmission of results |
Section 5.10.7 |
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Format of reports and certificates |
Section 5.10.8 |
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Amendments to test reports and calibration certificates |
Section 5.10.9 |
Please provide copies of the following documents as evidence of conformance.
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By completing the check-boxes and signing below, I hereby
attest that I have read and understood the requirements as outlined
in ISO/IEC 17025:2005 and my organization is conformant with the
requirements listed except as noted above and in the explained
attachments.
Signature: ______________________________________________________
Name: _________________________________________________________
Date: __________________________________________________________
Organization: ___________________________________________________
ISO/IEC Guide 65:1996 (Guide 65) Self-Audit Conformance Checklist
Please check each box as appropriate. If you believe that a particular requirement of Guide 65 does not apply to your application for authorization as an ONC-ATCB, please clearly identify the requirement and attach a detailed explanation for why the requirement should not apply.
Certification Body |
Section 4 |
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General Provisions |
Section 4.1 |
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Organization |
Section 4.2 |
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Subcontracting |
Section 4.4 |
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Quality Systems |
Section 4.5 |
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Conditions and procedures for granting, maintaining, extending, suspending and withdrawing certification |
Section 4.6 |
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Internal audits and management reviews |
Section 4.7 |
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Documentation |
Section 4.8 |
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Records |
Section 4.9 |
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Confidentiality |
Section 4.10 |
Certification Body Personnel |
Section 5 |
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General |
Section 5.1 |
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Qualification Criteria |
Section 5.2 |
Changes in certification requirements |
Section 6 |
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Changes in the certification requirements |
Section 6 |
Appeals, complaints, and disputes |
Section 7 |
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Appeals, complaints and disputes procedures |
Section 7.1 |
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Application for certification |
Section 7.2 |
Application for Certification |
Section 8 |
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Information on the procedure |
Section 8.1 |
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The application |
Section 8.2 |
Preparation for Evaluation |
Section 9 |
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Maintain records |
Section 9.1 |
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Prepare plan for evaluation activities |
Section 9.2 |
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Assign evaluation personnel |
Section 9.3 |
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Provision of working documents to personnel |
Section 9.4 |
Evaluation |
Section 10 |
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Evaluation |
Section 10 |
Evaluation Report |
Section 11 |
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Evaluation Report |
Section 11 |
Decision on Certification |
Section 12 |
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Decision on certification |
Section 12.1 |
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Delegation of authority |
Section 12.2 |
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Certification documents |
Section 12.3 |
Surveillance |
Section 13 |
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Documented surveillance procedures |
Section 13.1 |
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Product changes and modification updates |
Section 13.2 |
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Documentation of surveillance activities |
Section 13.3 |
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Periodic evaluation to confirm conformance of marked products |
Section 13.4 |
Use of licenses, certificates and marks of conformity |
Section 14 |
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Control over ownership, use and display of licenses, certificates and marks of conformity |
Section 14.1 |
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Guidance on use of certificates and marks |
Section 14.2 |
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Action in response to misrepresentation of certification systems, licenses, certificates and marks |
Section 14.3 |
Complaints to suppliers |
Section 15 |
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Complaints to suppliers |
Section 15 |
Please provide copies of the following documents as evidence of conformance.
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By
completing the check-boxes above and signing below, I hereby attest
that I have read and understood the requirements as outlined in
ISO/IEC Guide 65:1996 and my organization is conformant with the
requirements listed except as noted above and in the explained
attachments.
Signature: ______________________________________________________
Name: _________________________________________________________
Date: __________________________________________________________
Organization: ___________________________________________________
Agreement to Adhere to the Principles of Proper Conduct for ONC-ATCBs
Please confirm that you have read, understand, and agree that your organization(s) will adhere to the following Principles of Proper Conduct by checking the box next to each Principle of Proper Conduct and signing and dating the attestation below.
Principles of Proper Conduct for ONC-ATCBs |
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Operate a certification program in accordance with ISO/IEC Guide 65:1996 and testing program in accordance with ISO/IEC 17025:2005. |
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Maintain an effective quality management system which addresses all requirements of ISO/IEC 17025:2005. |
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Attend all mandatory ONC training and program update sessions. |
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Maintain a training program, consistent with the ISO/IEC standards that include documented procedures and training requirements to ensure its personnel are competent to test and certify Complete EHRs and/or EHR Modules. |
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Use test tools and test procedures approved by the National Coordinator for the purposes of assessing Complete EHRs and/or EHR Modules compliance with the certification criteria adopted by the Secretary of the U.S. Department of Health and Human Services. |
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As set forth in 45 CFR, Part §170.423; Final Rule (the Rule) Report to ONC within 15 days any changes that materially affect its:
(7) Other such matters that may otherwise materially affect its ability to test and certify Complete EHRs and/or EHR Modules. |
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Allow ONC, or its authorized agents(s), to periodically observe on site (unannounced or scheduled) during normal business hours, any testing and/or certification performed to demonstrate compliance with the requirements of the temporary certification program. |
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Provide ONC, no less frequently than weekly, a current list of Complete EHRs and/or EHR Modules that have been tested and certified which includes, at a minimum:
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Retain all records related to tests and certifications according to ISO/IEC Guide 65:1996 and ISO/IEC 17025:2005 for the duration of the temporary certification program and provide copies of the final results of performed tests and certifications to ONC at the sunset of the temporary certification program. |
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Promptly refund any and all fees received for:
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Ensure adherence to the following requirements when issuing a certification to Complete EHRs and/or EHR Modules:
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Further, I acknowledge and agree to abide by the regulatory requirements listed in 45 CFR, Part 170; § 170.465, Revocation of Authorized Testing and Certification Body Status.
As the applicant ATCB’s Authorized Representative, I agree and am bound to the above conditions for authorization. Further, I attest that all statements made in this application are correct to the best of my knowledge and are made in good faith.
Signature: ______________________________________________________
Name: _________________________________________________________
Date: __________________________________________________________
Organization: ___________________________________________________
1http://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2005&source=google&adgroup=iso9&keyword=iso%2Fiec%2017025&gclid=CKDg3_-XvKECFVhJ2god_AfX-w
2http://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+Guide+65%3a1996&source=google&adgroup=iso10&keyword=iso%2Fiec%20guide%2065&gclid=CL-5_L-XvKECFRRM5Qod0QigAw
File Type | application/msword |
File Title | APPLICATION TO ACHIEVE STATUS OF ONC-AUTHORIZED TESTING & CERTIFICATION BODY |
Author | Coon, Constanze |
Last Modified By | Michael L. Lipinski |
File Modified | 2010-11-17 |
File Created | 2010-11-17 |