Accreditation of EXcorLab GmbH
To meet the demands of our customers EXcorLab GmbH has established a quality management system which complies with the requirements of EN ISO/IEC 17025:2005. 2009 our organization has been accredited by DAR (Deutscher Akkreditierungs Rat), the responsible authority in Germany.
Our accreditation covers
- Biocompatibility testing
- Performance testing of membranes in medical devices (Determination of UFR, TMP, clearance of low melecular weight solutes, clearance of plasma proteins e.g. β2-microglobulin, myoglobin, albumin loss, sieving coefficient measurements)
- Optical Detection Techniques (Photometry / Fluorimetry / Light scattering techniques / Flow cytometry)
- Ligand assays (ELISA)
- Chromatographic techniques (HPLC, SDS gel electrophoresis)
- Physico-chemical techniques (determination of blood gases, electrolytes, pH, haematocrit)
- Cell counting using automated cell counters
- in vitro cytotoxicity
Our certificate may be viewed and downloaded here: Accreditation EXcorLab
Our quality management system, our techniques and methods are continuously developed further. 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 a notified body. 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 by the notified body in Germany, the DAKKS, to guarantee the compliance of our services with the norm EN ISO/IEC 17025:2005.
Thus, our accreditation offers, in particular, the following advantages for you as manufacturer, supplier, exporter or customer:
- Minimizing of risks
- Avoiding costly re-examinations
- Enhancing credit of your customers
- Reducing costs and promoting acceptance of your products
More information to this item are provide under
Laboratories may be also audited and certified according to an international 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 standardise 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 and well recognised scientists engaged by the notified body, 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 17025:2005 (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.
More information is available here:
Where possible we check our testing methods externally by participation in interlaboratory tests of e.g. INSTAND e.V. (Society for Promotion of Quality Assurance in the Medical Laboratories). 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 17025:2005 as the basis of accreditation of testing and calibration laboratories. Accreditation bodies from about 50 countries (including the EU, USA and Japan) signed a contract, to accept accreditaion of a laboratory audited by a notified body in one member state as if the accreditation was issued in another country. The so called ILAC Arrangement fosters the acceptance 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. A corresponding guideline is found under http://www.fda.gov/RegulatoryInformation/Guidances/ucm125434.htm