Accredited quality management system expanded at Fraunhofer IPA

Tests for in-vitro cytotoxicity. © Fraunhofer IPA / Photo: Rainer Bez

Determination of scratch resistance using a linear displacement device (Crockmeter). © Fraunhofer IPA/Photo: Rainer Bez

© Fraunhofer IPA

The Departments of Coating Systems and Paint Technology and Pure and Micro Production at the Fraunhofer IPA have received new accreditation certificates from the German Accreditation Body. Other specialized areas are thus accredited according to DIN EN ISO/IEC 17025 for testing research, industrial, and medical products.

The internationally recognized standard for laboratory accreditation in testing and calibration is set by DIN EN ISO/IEC 17025. The standard includes general requirements for competence, impartiality, and consistent working methods of laboratories. As the national accreditation body of the Federal Republic of Germany, the German Accreditation Body (DAkkS) has authorized additional specialized areas at the Fraunhofer Institute for Production Technology and Automation IPA.

For the entire accredited scope, the consistent implementation of the requirements of DIN EN ISO/IEC 17025 is pursued with the goal of achieving valid, reproducible, and comparable test results. The accredited testing laboratory at Fraunhofer IPA regularly demonstrates both technical competence for the norm-compliant implementation of the requirements of the respective testing standards and the fulfillment of the requirements of the overarching quality management system according to DIN EN ISO/IEC 17025, to the German Accreditation Body.

Pure Testing Technology and In-Vitro Cytotoxicity Testing Accredited

The Pure Technology unit from the Pure and Micro Production department is now newly represented with procedures from pure testing technology for evaluating the technical cleanliness of components (according to VDA Volume 19 Part 1 and ISO 16232) using light optical analysis and testing for particulate contamination (microscopy) of medical devices (VDI 2083 Sheet 21) within the scope accredited according to DIN EN ISO/IEC 17025.

Also new and located within the same organizational unit is the procedure for in-vitro cytotoxicity testing, accredited according to DIN EN ISO 10993-5. Experts from Fraunhofer IPA examine whether chemical substances can damage cells and tissues. The assessment of cytotoxic potential provides important insights into the biocompatibility of materials. Here, too, the accreditation now covers testing research and industrial products as well as medical devices – additionally confirmed by the Central Office of the Federal States for Health Protection concerning Medicines and Medical Devices (ZLG). For both testing areas, further testing procedures are in preparation for inclusion as accredited methods.

Accredited Testing Procedures in Coating Systems and Paint Technology

The testing procedures accredited for many years in the Department of Coating Systems and Paint Technology include corrosion and climate testing, physical-technical tests, coating thickness measurements, and durability tests on coated materials. Selected analytical tests and the determination of the so-called fogging behavior are also part of the scope. Fogging refers here to the condensation of evaporated volatile components from automotive interior equipment on glass surfaces, especially the windshield. The accredited procedures also include testing the burn and odor behavior of materials used in automotive interiors. The accredited testing procedures are divided among the organizational units of Analytics and Material Testing, Paint Chemical Application Technology, Paint Process Development, and Wet Application and Simulation Technology.

New Accreditation Certificates for Flexible Scope

In the new accreditation certificates, all accredited testing procedures are now based on a normative document (e.g., DIN EN ISO) recognized by the German Accreditation Body for the flexible scope. Consequently, factory testing specifications are no longer listed in the accreditation certificate.

An additional innovation in the accredited scope, which has also been incorporated into the accreditation certificate, is the change to the previously mentioned flexible scope. For all currently approved material tests (excluding testing of medical devices), the accredited testing laboratory could introduce the "Flexible Scope Category I." This flexible scope allows new testing procedures to be incorporated into the accredited scope quickly and flexibly within the approved and proven accreditation areas, based on a recognized normative document.

The accreditation certificates and the current scope of accreditation for each approved testing procedure can be viewed on the Fraunhofer IPA website.