Manufacturer Laboratory Authorization

Overview of main requirements:

• Quality system according to the relevant parts of ISO/IEC 17025
• Qualified testing personnel with knowledge of standards and test methods, (IEC/EN, CISPR, ETSI, national etc.)
• Necessary test facilities and equipment with proper characteristics and tolerances
• Calibration procedures traceable to national or international reference standards with regular calibration intervals

Authorization Process

Application

Together with the application documents with basic description of the company, the following is requested.

• Description of the Quality System
• List of personnel and their brief CVs
• List of testing equipment/instruments, including power supply and other relevant site data
• List of testing standards including experience data (number of test reports conducted last 2 years)
• Reference to other authorizations/accreditations, if any

Initial Assessment

• To evaluate the ability of the candidate laboratory to perform testing, Nemko will make an initial site assessment which will include (as applicable):
• Audit of the testing facilities, equipment and instruments
• Evaluation of the competence of testing personnel, including knowledge of current standards and supervision of performed testing
• Evaluation of the quality system of the laboratory

Verification of tests

Prior to issuing an Authorization, Nemko will conduct a careful verification of the laboratories testing capability (normally 3 test reports). Depending on the experience of the laboratory this may include comparative measurements and evaluation by another laboratory, selected by Nemko.

Authorization

When the candidate laboratory has successfully passed the initial assessment, the verification of testing capability and fulfills the other conditions for Nemko’s Laboratory Authorization, an attestation of the Authorization is issued to the laboratory.

Follow up

In order to ensure that the conditions of the Authorization are further satisfied, Nemko staff will re-assess the laboratory normally on an annual basis, unless the laboratory is nationally accredited to ISO/IEC 17025, in which case the assessment is normally conducted every third year.

These re-assessment visits may be combined with exchange of relevant information and training activities in regard to the ongoing testing and certification activities. More frequent visits may also be considered appropriate, subject to agreement between Nemko and the laboratory.

Costs

The applicable rates at any time are provided by Nemko on request.

Withdrawal of Authorization

The Authorization is valid until cancelled by the laboratory, or withdrawn by Nemko based on lack of compliance with the conditions involved or if the lab neglects to notify Nemko on relevant changes or otherwise misuse the Authorization.

Supporting Documents

Application forms, check lists, templates for assessment reports and certificates as well as cost indications are available on request to info [at] nemko [dot] com or from your regular contact at Nemko.