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NanoLogix, Inc. Message Board

  • commishfree1 commishfree1 Aug 29, 2010 9:52 AM Flag



    Anybody familiar with this validation process? Seems as if you want to sell test kits for food/water bacterial analysis in Europe, you should have your method validated by this organization.

    AFNOR Certification is a certifying body governed by the European standard EN 45011. AFNOR Validation is a European collective mark owned by the AFNOR Group. It has been registered and is protected in Europe.

    AFNOR VALIDATION certification is managed by a Technical Board of approximately 20 people, consisting of representatives of all the parties concerned, divided into the following groups:

    1 - users (public and private laboratories)
    2- technical organisations (laboratory accreditation organisation, technical centre of industries concerned, health safety agency,…)
    3 - authorities (agriculture, health, environment, …depending on application)
    4 - kit manufacturers worldwide

    All validation applications, without exception, are examined by a board of microbiology experts (the technical board) whose members are divided equally into groups. Thus, from the outline preliminary study to the results of the inter-laboratory study, each application is presented to the technical board and each method is assessed in detail. For each method to be validated, two members of the technical board are appointed to monitor the validation study closely and give their opinion to the board.

    Validation studies are conducted by laboratories called “expert laboratories”. These laboratories, previously accredited for the reference methods they want to implement, are approved by AFNOR Certification, on the basis of criteria set by the technical board. AFNOR Certification has an up-to-date list of approved laboratories.
    For each study, the manufacturer chooses a laboratory from the list, which must be independent from its company.

    Finally, AFNOR Certification has approved a number of auditors whose task is to carry out audits on the production site for the purposes of validating methods or monitoring validated methods.

    The network of experts set up and managed by AFAQ ANOR Certification guarantees a thorough and detailed evaluation of each method applying for validation, both for the initial application and for renewals or extensions. The members of the technical board (including the reviewers and the majority of expert laboratories) examine many applications at every stage each year, consolidating their expertise and therefore guaranteeing the pertinence, consistency and quality of the evaluations carried out.

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