NordVal International / Apply for certificate
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Address
NMKL NordVal International
c/o Institute of Marine Research
P.O. box 1870 Nordnes
5817 Bergen, Norway
NordVal International / Apply for certificate
The experts involved in NordVal International Technical Committees and in the Steering Group are independent, i.e., they sign not to have any economic gain in any alternative method development or sale. NordVal International keeps the communication with customers confidential. NordVal International can describe the principle of the method and the results of the validation studies in the certificate. Please see Privacy Policy for further details.
Our customers are normally the producer and/or vendor of the alternative method applied for. The customer signs the agreement directly with NordVal International as well as directly with the independent expert laboratory they appoint.
The NMKL secretariat handles the invoicing, assisted by our host institute Institute of Marine Research (NO), and forwards inquiries from customers and expert laboratories to NordVal International. See the purchasing process table at the end of this page.
If the study followed the workflow and results are satisfactory NordVal International issues a certificate and the customer pays the whole fee.
If the results are not satisfactory, a NordVal certificate cannot be issued.
If NordVal International finds that
The customer can terminate the certification process at any time. As technical experts have to be called upon for reviews of study plan, comparison study and interlaboratory validation study, the customer has to pay 1/3, 2/3 or 3/3, respectively, of the fee, depending on at which stage the process is terminated.
A NordVal International certificate proves the fact that the alternative method performs equivalent, or better, to a reference method.
The certificate shall include certification number, approval date and expiry date, name and address of the applicant, a reference to the reference method, the principle of the alternative method, and the results of the validation studies.
The customer must always, and without delay, inform NordVal International of any changes that affect its ability to conform with the certification requirements. The customer must keep record of all complaints made known to the customer and any deficiencies found in products that affect compliance with the requirements for certification and take appropriate action. The production must be certified according to a quality management system, e.g. ISO 9001.
The certificate is valid for two years. The secretariat sends a renewal form 4-6 months before the certificate expires. The customer shall specify in the form whether or not the method and the package insert have been changed since last approval, and inform about any other changes. NordVal International evaluates these changes – if any – and decides to which extent new comparative and collaborative studies should be carried out.
If the reference method used for the validation has been changed since last approval NordVal International evaluates these changes and decides to which extent new comparative and collaborative studies should be carried out.
Purchasing Step | Customer (Applicant) | NordVal International |
---|---|---|
1 – Requirement | Contacts NordVal for information about the service. | Informs about the reviewing process referring to the workflow. Emails application form including terms and conditions. Prices are communicated and protocols for expert laboratories presented. |
2 – Procurement | Fills in application form with information about the method and appointed independent expert laboratory (IEL) and emails to post@nmkl.org | Reviews the application form, emails a quotation for customer to place order, asks for customer PO# for invoicing. |
3 – Placing order | Reviews quotation and places order with customer PO#. Signs the application (contract). | Reviews the final application (contract) and archives together with the quotation including PO#. |
4 – Service a) Method study plan b) Method comparison study c) Interlaboratory study d) Method certificate | a) IEL creates a MCS plan and reports to NordVal.
b) When approved, IEL performs MCS and reports to NordVal. c) When approved, IEL performs ILS and emails the report and package inserts to NordVal. d) When approved, the customer/IEL review the certificate and reports to NordVal. | a) TC and SG review MCS plan.
b) TC and SG review MCS report. c) TC and SG review ILS report and package inserts. If approved, NordVal drafts the certificate. d) Drafts and issues the certificate when reviewed by the customer and quality assured by NordVal. |
5 – Payment | Receives invoice (pdf) in accordance with the quotation, the PO# and service conducted. | Issues invoice with 30 d due. The NMKL host institute, Institute of Marine Research, handles the invoicing. |
Table abbreviations: IEL, Independent Expert Laboratory; SG, Steering Group; TC, Technical Committee; MCS, Method Comparison Study; ILS, Interlaboratory Study.