Accreditation confirms the formal recognition of our testing competence in selected areas (see Directory of Service) by DAKKS. It represents a tool for our customers to identify a competent laboratory and choose reliable services for testing which meets their specific requirements e.g. in the area of medical devices. To maintain our accreditation we will be re-audited in regular intervals to guarantee the compliance of our tests and services with the norm EN ISO/IEC 17025:2018.

Thus, our accreditation offers, in particular, the following advantages for you as manufacturer, supplier, exporter or customer:

More information to this item is provided under https://ilac.org/about-ilac/

Laboratories may be also audited and certified according to an international QM-standard, called ISO 9001. This standard is widely used by manufacturers and service providers to assess the quality of their products and services. ISO 9001 is a tool to standardize the quality management system but it is not suited to assess the technical competence of a laboratory. This means that the certification according to ISO 9001 does not ensure that data aquired during testing are precise, reproducible and reliable. Thus, the evaluation of competence and data quality of a certified testing laboratory relies solely on own experience of the customer with the laboratory or on information provided by the laboratory itself about its competence.

In contrast, the accreditation process of laboratories is using laboratory specific criteria and procedures to evaluate technical competence. Expert supervisors/auditors and well recognised scientists engaged by DAKKS, often working in similar laboratories, check thoroughly all aspects influencing the generation of scientific data within a laboratory. The criteria are based on the international norm EN ISO/IEC 17025:2018 (a “competence norm”) which is used for the evaluation of laboratories worldwide. This standard addresses, in particular, the most relevant factors involved in generation of precise testing and calibration data. These include:

Also, the accreditation of a laboratory includes the relevant quality management elements addressed in ISO 9001.

Where possible we check our testing methods externally by participation in round robin tests (interlaboratoty tests) of e.g. INSTAND e.V. (Society for Promotion of Quality Assurance in the Medical Laboratories) and RfB (Reference Institute for Bioanalytics). Corresponding certificates on individual parameters are available on request.

Many countries worldwide have an organisation which is responsible for the accreditation of laboratories. Most of the national accreditation bodies use EN ISO/IEC 17025:2018 as the basis of accreditation of testing and calibration laboratories. Accreditation bodies from about 60 countries (including the EU, USA and Japan) signed a contract, to accept accreditaion of a laboratory in one member state as if the accreditation was issued in another country.

The so called ILAC Arrangement fosters the IAFacceptance of accreditation across national borders. For details of the ILAC Arrangement visit the ILAC’s homepage at www.ilac.org.

Also, the FDA recommends accreditation of testing laboratories according to ISO/IEC 17025.