Accreditation

Accreditation of eXcorLab GmbH

Our test reports bear the logo of the accreditation body and our registration numbers D-PL-19275-01-00 and D-PL-19275-02-00.

Our accreditation covers

Biological and physical testing of medical devices; Environmental monitoring (D-PL-19275-02-00)

  • Hemocompatibility of medical devices acc. to DIN EN ISO 10993-4
  • Physical and performance characterization according to DIN EN ISO 8637-1 and DIN EN ISO 7199
  • Determination of damage, retention and activation of blood and blood components by transfusion devices/sets according to DIN EN ISO 1135-4, 1135-5
  • MAT test (monocyte activation test by pyrogens) according to Ph. Eur. 2.6.30
  • Bacterial endotoxin testing (LAL test) according to Ph. Eur. 2.6.14

Our certificate may be viewed and downloaded here:

Certificate of accreditation

Healthcare, medical laboratory testing within the context of clinical studies (flexible scope of accreditation D-PL-19275-01-00)

Testing field: Clinical chemistry, including (but not limited to) the following methods:

  • Optical Detection Techniques (photometry, nephelometry, flow cytometry, potentiometry)
  • Ligand assays (ELISA)
  • Chromatographic techniques (HPLC, SDS gel electrophoresis)
  • Electro-chemical techniques (determination of blood gases, electrolytes, pH)
  • Cell counting using automated cell counters

Our certificate and list of the flexible scope of our accreditation (D-PL-19275-01-00) may be viewed and downloaded here:

Certificate of accreditation

List of the flexible scope of our accreditation

Our quality management system, our techniques and methods are constantly evolving. We encourage all our employees to actively participate in this ongoing improvement process.

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:

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:

  • Technical competence of the employees
  • Validity and adequacy of the methods
  • Traceability of tests and calibrations to national standards
  • Adequate use of measurement uncertainty
  • Adequacy, calibration and maintenance of testing equipment
  • Testing environment
  • Sampling, handling, transport and storing of test specimen
  • Quality management of data and statistics

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.

nach ISO/IEC 17025.