Li, X.MLZ* ; Hutanu, V.MLZ* ; Jeschke, F. ; Pichlmaier, A.MLZ*

2023

Abstract: More and more industrial customers require quality management (QM) systemimplementation and certification for their entire supply chain of the irradiation serviceat research reactors. In addition, users from the nuclear medicine and materialscience desire also such QM certificates for the isotope production or analysis.Neutron irradiation procedures aiming isotope production and the activation ofsamples for analytical purposes, including the Silicon doping, have been certificatedaccording to the ISO 9001:2015 at the research reactor FRM II since years.Additionally, the procedures for the gamma-irradiation in the spent fuel elements andthe instrumental neutron activation analysis (INAA) will get certified soon. In thisreport, the main working model “Plan-Do-Check-Act” and the QM manual as amaster tool for the implementation of ISO 9001 for industrial applications at FRM IIare described.1. IntroductionNowadays, research reactors provide worldwide services for the whole society, not only for theeducation and research works, but also more and more for the industry, medicine or otherfields. In some sectors, the research reactors as an indispensable service provider havealready become an integral part of the supply and production chain, e. g. neutron transmutationdoping of Silicon (NTD) for the semi-conductor industry or production of radiopharmaceuticalsfor the clinical use.With the continuous expansion of the scale of services, more and more industrial customersrequire quality management (QM) system implementation and certification for their entiresupply chain including the irradiation service at the research reactors. For this reason, someresearch reactors like SAFARI in South Africa and BR2 of the SCK CEN in Belgium havealready obtained certification of ISO 9001 for their production of isotopes [1, 2].The FRM II reactor of the Technical University of Munich (TUM) followed this trend. As a high-performance neutron source, many possibilities for providing services to industry were takeninto account already at the design stage of the FRM II. After the successful commissioning ofthe first prototype of silicon doping system in 2006, which was a facility facing to the industryfrom the beginning only, the preparation of a certification started. The first valid certificateaccording to ISO 9001:2000 at FRM II was already issued in the next year 2007.Later, neutron irradiation procedures aiming isotope production and the activation of samplesfor analytical purposes on the other irradiation facilities were certified to the following editionof ISO 9001:2015. Furthermore, the gamma-irradiation facility in spent fuel elements and thewhole procedure of the neutron activation analysis, including the counting system for thegamma-ray spectrometry, are also currently prepared for the upcoming certification. (PDF) ISO-certification of the irradiation facilities for commercial applications at FRM II. Available from: https://www.researchgate.net/publication/370270935_ISO-certification_of_the_irradiation_facilities_for_commercial_applications_at_FRM_II [accessed Feb 25 2026].

Keyword(s): Engineering, Industrial Materials and Processing (1st) ; Industrial Application (2nd)

1. IRRAD (IRRAD)

1. Irradiation facility