INFORMATION AND DOCUMENTS TO BE SUPPLIED BY LABORATORIES IN THE APPLICATION FOR APPROVAL
The application file shall include the following information and documents:
1. The name and address of the applicant organisation;
2. The legal status and, where applicable, the composition of the board of directors of the applicant organisation;
3. The name and address of the laboratory carrying out the analyses, if different from those of the applicant organisation;
4. The date on which the laboratory was set up;
5. The full name of the laboratory director and, if applicable, the chairman of the board of directors;
6. Documents justifying the laboratory’s sources of funding;
7. The organisation chart of the laboratory’s staff;
8. The full name, position, professional qualifications, curriculum vitae and diplomas of the laboratory director, the chairman of the board of directors and the person(s) responsible for taking samples and/or performing analyses;
9. The list of analyses for which approval is sought; the analysis methods used;
10. The accreditation certificate and technical annex issued by COFRAC or any other equivalent European body that is a signatory to the multilateral agreement concluded within the framework of the European co-ordination of accreditation bodies for the analyses covered by the application for approval;
11. A sworn statement from the head of the laboratory certifying :
– its undertaking to carry out the analyses for which it is applying for approval, under the conditions and in accordance with the procedures defined for accreditation, and to deliver the results corresponding to these analyses, under accreditation;
– its undertaking of confidentiality, impartiality and independence with regard to the analyses and sampling activities carried out;
– its undertaking to transmit the results of the analyses to the public establishment mentioned in article L. 3512-15 of the Public Health Code as quickly as possible;
– its undertaking to inform the public establishment referred to in Article L. 3512-15 of the Public Health Code without delay of any anomalies or non-conformities detected.
Three copies of the application must be sent by post with acknowledgement of receipt to the public establishment referred to in article L. 3512-15 of the Public Health Code.