NordVal International / Apply for certificate

Workflow overview

NordVal International

The NMKL secretariat handles the communication between the customer (applicant) and NordVal International and between the expert laboratory and NordVal International. Formalities are explained in our terms and conditions.

  1. Customer files an application

The customer fills in and emails the new application form to the NMKL secretariat. This gives the Steering Group (SG) of NordVal International information about the applicant, the method, the required certified quality management system for production, and the expert laboratory to be assigned. The application will be evaluated and should be approved by NordVal International before proceeding. A quotation will be sent to the customer and the customer signs the application form which is the formal agreement with NordVal International.

  1. Customer appoints an independent expert laboratory

The customer appoints an independent expert laboratory fulfilling the requirements that must be named in the application and approved by NordVal International. The customer signs an agreement directly with the expert laboratory.

  1. Expert laboratory makes a study plan

The expert laboratory forwards a study plan for method comparison study (MCS), and interlaboratory study (ILS) if applicable at this stage, for approval by NordVal International. The study plan and the validations must be according to our validation protocols. For microbiology studies, matrix lists are available. NordVal International can, upon request, assist the expert laboratories in the elaboration of the study plan and statistical calculations of results.

  1. Expert laboratory carries out the method comparison study

The MCS is an extensive study testing the selectivity and the reliability of the method. The expert laboratory reports the results to NordVal International.

  1. NordVal International reviews the method comparison study report

A Technical Committee (TC) is appointed by the NordVal International SG. The TC might have questions to the expert laboratory. The TC presents a report of recommendation to SG. SG evaluates the TC report and makes the final decision of approval.

  1. Expert laboratory carries out the interlaboratory validation study when/if the MCS is approved

The ILS is organized by the expert laboratory and results reported to NordVal International. Only one matrix is required.

  1. NordVal International reviews the interlaboratory validation study report and package inserts

The ILS and package inserts are reviewed as explained in point 5.

  1. NordVal International drafts a certificate when/if the interlaboratory validation study is approved

The customer will get a draft certificate to review and comment. See our terms and conditions for handling of aborted studies.

  1. NordVal International issues and publishes the final certificate

The issued certificate is valid for 2 years and will be freely available from our web page and the method announced in the NMKL newsletter. See our issued certificates here.

  1. Customer files a renewal application

A notification will be sent to the customer 4-6 months before the certificate is to expire. To renew the certificate, or extend the method, fill in, sign, and email the application form.

Reviewed by NordVal International

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– Application
– Independent expert laboratory
– Study plan
– Method comparison study report
– Interlaboratory study report
– Package inserts