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Manufacturer Laboratory Authorization

image/jpeg iconManufacturer Laboratory Authorization

Nemko’s laboratory authorization program is established with the purpose of allowing test results from competent external laboratories to be used as basis for Nemko Certifications / Attestations. The program is offered for both manufacturers’ laboratories and independent laboratories and may cover one or more testing areas, such as Safety, EMC, Telecom or Ecology according to relevant standards.

For Nemko’s N-mark certification, attestation for CE-marking etc., the authorization program is applicable for manufacturers’ laboratories as well as independent partner laboratories. For the multi-national services (like the international IECEE CB scheme and the European CCA/ENEC), the use of such program is, however, restricted to manufacturers’ testing laboratories (MTL).

Nemko’s own Testing By Manufacturer (TBM) program was established already in 1975. Since that time, similar multi-national programs have been developed within the international IECEE and the European Certification System (ECS) in which Nemko takes active part. The TBM program has therefore been gradually merged into the program structure within these schemes.

Thus, the basic terms of reference are now the relevant rules and procedures of the IECEE, i.e. the Operational Documents CB-2027-2031 and OD-2032, which are accessible on www.iecee.com.

Options

For manufacturers’ testing laboratories, after initial assessment and acceptance of the laboratory, the testing may be performed by Nemko personnel at the manufacturer’s premises (TMP), or the manufacturer’s testing may be witnessed by Nemko personnel (WMT) or subject to periodical supervision by Nemko personnel (SMT). The latter also entails periodical assessment of the maintained capabilities of the laboratory.

The acceptance of a laboratory is based upon mutual understanding of product testing and certification practice, verified through audits and reviews of test projects. After initial assessment of the laboratory’s capabilities and the relevant parts of its quality system, follow-up audits are carried out periodically by Nemko staff to ensure continuous technical knowledge and understanding of relevant administrative routines.

The main benefits for the authorised laboratories:

  • Streamlined handling of certification projects at Nemko
  • Predictable outcome of projects due to common practice and understanding
  • Opportunity to be updated on current and coming product standards and up-to-date knowledge of testing practices due to close contact between the personnel involved
  • Access to organised proficiency/comparative test programs
  • Gives the manufacturers maximum flexibility and control over introduction of their products to the market.
  • Quick response to questions arising during the product development phase.
  • Reduced testing/certification fees.
  • Avoiding shipments of samples for testing.

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

Annual Fee To cover maintenance of the program, updates, ad-hoc consultancy etc
Audit Fee To cover maintenance of the program, updates, ad-hoc consultancy etc
Certification This will vary depending on product and Attestation / Certification requested
Travelling Charged at cost

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.

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