Environment

Test Bodies

What is a Test Body?

During the verification procedure, if additional tests are needed, the proposer designates one or more Test Bodies for testing or for supporting testing done by the proposer. The Test Bodies should comply to the ISO 17025 standard for the methods of testing and calibration relevant for ETV or should be certified by the EN ISO 9001 standard. The staff involved should be independent from the one responsible for the evaluation of the test results in the Verification Body. Please note that absence of accreditation or certification of a test body does not exclude it from performing testing for verification purposes. In this case however, the proposer should be aware that in order to meet the overall quality requirements of the verification procedure, the Verification Body is obliged to check the quality management system of the test body by means of an audit. This activity will result in additional costs to be covered by the proposer.

What is the role of the Test Body in the verification?

Test bodies are responsible for:

  • drafting a test plan in agreement with the Verification Body taking into account the requirements of the GVP and the specific verification protocol;
  • performing the tests, ensuring the level of quality required in the specific verification protocol;
  • ensuring quality of analysis used in the test and, when applicable, the compliance of analytical laboratories with the requirements of this GVP;
  • drafting the report on the tests performed

How can I become an ETV Test Body?

Test bodies are designated by the proposer in consultation with the Verification Body. A specific accreditation or certification to perform tests or analysis under ETV is not foreseen and rather complies with existing quality management procedures and standards. Therefore any organisation that is able to provide reliable and auditable test results and analyses can be eligible to supply results for a proposer taking part in an ETV procedure. The only requirement is that there is an independence in the production of the results and that these provide sufficient quality assurances to be accepted by the Verification Body under the strict quality requirements of the ETV programme.