Get the free Application Form for Validation and Certification of Diagnostic Tests

Standard Operating Procedure (SOP) for ONE Validation and Certification of Diagnostic Assays Application Form for Validation and Certification of Diagnostic Tests Use this form to submit an application

Applicants must be the test holder for that particular diagnostic test and have completed the certification process specified on the SOP. In order to submit your application you must provide verification that you've submitted the calibration samples for the test. You will receive a notification from ONE within 7 to 14 calendar days of the receipt of your verification and the processing of your application. Please be sure to read 'Validation and Certification Process and Procedures: Information and Administrative Forms' prior to submitting your application. Important: Each laboratory has different processes for the validation and registration of tests. In order to meet the validity requirements, it is recommended (but not required) that the analytical product, the test and its sample package be sent for validation and/or certification as soon as possible after the testing is completed. Please contact ONE or a laboratory for information on when to send the samples. Once validated and approved you will receive a confirmation email from ONE. Before filling out the Application Form, please call ONE at or email if you need more information or have questions. Applications must be submitted by 4.30pm London time (GMT) for validation and certification procedures. You cannot submit an application for validation and certification if the sample is not validated by ONE and/or has not been certified by ONE, as per the procedures above. To complete an application for validation and certification of tests (SOP), applicants must have an official validation and certification document (validation and/or certification) from one of the following four recognized European organizations: Department DES sciences DE la matter et de la Santa et de recherché Department DES sciences DES matters de recherché Department de recherche energies University de Lyon Please read 'Technical Description of Laboratories' and 'Technical Validation Process and Procedures' prior to filling out the Application Form (available on ONE's website), because the instructions differ from SOP's, and are given in French only. Application Form (SOP): This form is used for both validation and certification of tests and for other administrative procedures. To get a signature the applicant must sign (or affix his or her name) with the signature of a responsible person authorized to sign.

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