The independent expert laboratory must comply with the requirements of EN/ISO 17025 and it must be accredited. It is preselected by the manufacturer (or the MCB) from the database of laboratories established by the MGC. Collaborative laboratories are selected by the expert laboratories and they participate in the interlaboratory study. Collaborative laboratories must comply with EN/ISO 17025 but do not need to be accredited.
The independent expert laboratory is in charge of the co-ordination and the supervision of the two phases of the validation procedure:
- A method comparison study of the alternative method against the reference method
- An interlaboratory study of both methods.
The expert laboratory must comply with the requirements of EN/ISO 17025 and be accredited. The expert laboratory is pre-selected by the manufacturer or the MCB from the database of laboratories to be established by the MGC. The qualification "expert laboratory" is only valid for the MicroVal certification of the alternative method it was selected for.
The expert laboratories select the collaborative laboratories. There is no limit to the number of collaborating laboratories; however, a minimum of eight from three different countries is required for the study to be valid. The expert laboratory will report to the Technical Committee of the MCB, which will propose a certification proposal to the MCB. The final decision is taken by the MCB. The secretariat of the MGC is informed of this decision.
List of MicroVal qualified laboratories(To become a MicroVal approved expert laboratory, please download the questionnaire).
|ASEPT SAS||Mrs. M. Coignard||Rue des docteurs, Calmette et Guerin, PB 2047, 53020 Laval, Cedex 9||France|
|Adria Développement||Mrs. D. Sohier||2 A Creac'l Gwen, 29196 Quimper, Cedex||France|
|Campden BRI||Mr. R. Betts||Chipping Campden, Gloucestershire, GL 55 GLD||United Kingdom|
|Foedevaregion Nord *||Mr. E. Dahm||Sofiendalsvei 90, DK - 9200 Aalborg SV||Denmark|
|Institut Pasteur de Lille SERMHA||Mrs. V. Ewe||Rue du Professeur Calmette, BP 245, 59019, Lille Cedex||France|
|Institut Scientifique d'Hygiene et d'Analyse (ISHA)||Mr A. Boubetra||25, Avenue de la Republique 91300, Massy||France|
|Institute of Food Quality and Food Safety University of Veterinary Medicine Hannover||Mr A. Abdulmawjood||Bischofsholer Damm 15, 30173 Hannover||Germany|
|Institute of Veterinary Food Science, University Giessen||Mrs. F. Düker||Frankfurter Str. 12, 35392 Giessen||Germany|
|Instituto Zooprofilacttico dell'Abbruzzo e del Molise||Mrs. dr. R. Lelli||Via Campo Boario, Teramo, 64100||Italy|
|Q Laboratories, Inc.||Mr. D. Goins||1400 Harrison Ave, Cincinnati, Ohio, 45214||USA|
|Qlip||Mr H v.d. Bijgaart||Kastanjelaan 7, 3833 AN Leusden||The Netherlands|
|RIVM, LZO||Mrs. W. Jacobs||PO Box 1, 3720 BA Bilthoven||The Netherlands|
* Foedevaregion Nord is an approved MicroVal Expert lab, but will momentarily only accept collaborative work.
Update: October 2012
Requirements to become MicroVal Expert Laboratory(From MicroVal Rules and Certification Scheme, version 7, October 2012)
4.5.1 Expert laboratory
The expert laboratory is in charge of the co-ordination and supervision of the studies within the certification procedure.
The expert laboratory shall have an accreditation according to the EN-ISO 17025 requirements for the reference methods in the field of the expertise claimed. The accreditation shall be granted by an organisation that is a full member of ILAC (International Laboratory Accreditation Cooperation). The field of expertise is described as the types of micro-organisms to be tested within the validation study according to EN-ISO 16140.
Sufficient experienced staff (managerial and technical) for the method validation study must be available. The organisation should not be involved in development and/or marketing of a proprietary method that they will be validating. The expert laboratories staff shall have experience in:
- preparation and checks (stability and homogeneity) of samples containing sub lethally injured micro-organisms to be used in method comparison study and collaborative study.
- organisation of collaborative studies (preferably at international level).
- statistical analysis of the data using the procedures described in EN-ISO 16140 (when the expert laboratory does not have the statistical expertise in house, it must demonstrate the competence of external statisticians involved in the validation studies)
- writing scientific reports and/or publications.
Additionally, the expert laboratory should be able to show that it will be fully trained in the use of the alternative method, and that its staff is considered technically competent to operate the alternative method, before validation work begins.
Note: If not all of the areas of expertise are available at the moment of application it must be demonstrated how the organisation would become acquainted with this area of expertise.
The procedure for the selection of an expert laboratory is defined in Annex D. This annex is divided in 2 parts, D-1 for becoming an expert laboratory and D-2 for selecting an expert laboratory for a validation study.
A contract shall be signed between the expert laboratory and the Certification Body involved in the certification procedure. The clauses that must be integrated in this contract are described in Annex E.
4.5.2 Co-operative laboratory
If necessary, the expert laboratory may ask for the assistance of a co-operative laboratory. The co-operative laboratory shall comply with the same requirements as the expert laboratory (see 4.5.1). The work of the co-operative laboratory shall be clearly identified in the final report of the expert laboratory.
4.5.3 Collaborative laboratories
The collaborative laboratories participate in the interlaboratory study and are selected by the expert laboratory on the basis of their capability.
The collaborative laboratories must be representative of the users of the method. If they are not EN-ISO17025 accredited, the collaborative laboratories must at a minimum have written instructions and quality control data, for the calibration of equipment, report on error and temperature abuse during incubation. Written documentation is normally sufficient for the expert laboratory, but in addition it can visit the collaborative laboratory.
The number of laboratories, from 3 different countries, involved in the interlaboratory study must be in accordance with the EN-ISO 16140.
The MicroVal General Committee will only consider exceptions on a case-by-case basis.
Annex D - Procedure for the selection of an expert laboratory
D.1 Becoming an expert laboratory.
To become an expert laboratory included in the MicroVal expert laboratory database an application form (MicroVal questionnaire for expert and collaborative microbiology laboratories) must be filled in. The questionnaire must be updated every 4 years. The expert laboratory has to fulfill the requirements described in 4.5. The evaluation of the application will be done by the Expert Committee that will give a recommendation for (dis)approval to the MicroVal General Committee (MGC). The MGC decides on the suitability of the applicant to become an expert laboratory in the area of expertise claimed.
D.2 Selection of an expert laboratory for a validation study
The laboratory must be selected from the database of laboratories, which is held by the Secretariat.
This selection is made by the supplier or by the MicroVal Certification Body, when the supplier requests MicroVal certification of a method.
The expert laboratory qualification is appraised by the MicroVal Certification Body for each separate request for MicroVal certification.
A specific contract is signed between expert laboratory and MicroVal Certification Body (see Annex E).Information given in the database is:
- name of organization
- type of organization
- R&D within the organization, if yes how many persons
- subdivision, if yes national/international
- R&D, if yes what type
- involvement of proficiency testing or ring testing
- accreditation or certification of the laboratory
- field of competence, reference methods used in the laboratory.