The organization of the INAA laboratory at the Interfaculty Reactor Institute at Delft, The Netherlands, has been brought in accordance with the requirements of Euronorm EN45001 and ISO guide 25 for quality systems. Procedures, techniques and instructions involved in routine INAA have been fully described and documented, and compiled in a quality manual. The implementation of such a quality system and of its accreditation for an INAA laboratory in a university environment are discussed.
In the mid 1990s, the National Physical Laboratory (NPL) took the decision to seek external accreditation to the then UK national
accreditation standard (M10, M10 supplement and M11) through the NPL’s National Measurement Accreditation Service (NAMAS).
This paper details the reasoning behind that initial decision and, in particular, how this impinged on the day-to-day activities
of the NPL’s Radioactivity Metrology Group (RMG). In the intervening decade, the accreditation standard has changed considerably;
accreditation is now to the international standards ISO 9001:2000 (Quality Management Systems: Requirements) and ISO 17025:2005
(General Requirements for the Competence of Testing and Calibration Laboratories); accreditation is now carried out by a wholly
separate successor organization to NAMAS, the United Kingdom Accreditation Service (UKAS). To meet the new accreditation requirements
the RMG: realigned it’s scope of work; streamlined and consolidated written procedures, references and appendices; centralized
the collection of written procedures, and clarified the document identification system. Future developments will include efforts
for RMG accreditation for conducting proficiency tests and providing reference materials.
Increasingly govemmental bodies and industry require that supporting analytical laboratories have their quality assurance program implemented in a quality system by international standards such as derived from the ISO-25 guide. Neutron activation analysis (NAA) laboratories may have to deal with this trend too. In universities and research laboratories the need for it, and the implications of total quality management system are sometimes misconceived by unfamiliarity with the issue. The laboratory for INAA in Delft has been accredited for its quality system since 1993. Some of the tangible improvements since the introduction of quality management are presented. Four strategical considerations are given to consider the introduction of quality management at NAA laboratories, viz. with respect to the role of NAA for the validation of other methods, the role of NAA in the certification of reference materials, the preservation of knowledge and the acceptance of NAA as a respectable method.
A melting point measurement facility for the UK has been developed and accredited to ISO/IEC 17025 Calibration status for
the determination of the liquefaction temperature of pure substances from 35 to 250°C.
The facility is based upon a commercial instrument, i.e. an oil bath fitted with an aluminium block (Isotech, model 798 EHT),
a precision multimeter (Isotech TTI-7), a thermocouple directly inserted in the sample under investigation and a platinum
resistance thermometer (PRT) tracking the block temperature. The homogeneity of temperature bath/block was investigated and
the PRT used for the traceability of the measurements was calibrated by NPL and traceable to ITS-90. The process was validated
using four current LGC Certified Reference Materials (CRMs):
Carbazole; material number: LGC2409, batch number: 007; liquefaction point: 245.58±0.07°C
Different approaches were used to identify reproducible features of the melting point (time-temperature) curves of these four
CRMs. Excellent correlation was observed between the certified values for the liquefaction point of the four CRMs and the
temperature at the end of their respective melting point curve plateau, determined using a temperature differential approach.
An uncertainty budget was derived and the expanded uncertainty at the 95% confidence interval (k=2) was found to be
A 2008. évi XXI. genetikai törvény a humángenetikai vizsgálatok és kutatások hazai kodifikálásának mérföldköve. A törvény a nemzetközi jogszabályokkal harmonizál, EU-konform. Garantálja az önrendelkezési jog és a szakma szabályainak teljes körű érvényesülését. A legális működés feltétele az intézményi akkreditáció, a rendszeres auditálás, az állami felügyelet rendeletszintű szabályozása és a koordinált hálózati felépítés lehet. A végrehajtáshoz további kormány- és miniszteri rendeletek szükségesek. Orv. Hetil., 2012, 153, 683–689.
General criteria for the operation of testing laboratories according to standards series EN 45000 and quality assurance under
ISO series 9000 are discussed, and other quality management systems too are presented. The important elements of quality assurance
as concerns measurements, tests and investigations are pointed out.
Morphological identification of larvae and adults of the EU quarantine pest Thrips palmi is one of the routine procedures of the National Reference Laboratory (NRL) of the Dutch Plant Protection Service. The quality of a morphological identification depends on several technical requirements, most important of which are laboratory facilities, literature, reference collection, quality of the available specimen(s) and skills of the specialist. To be able to consistently produce valid identification results, the NRL has implemented a documented quality management system within the laboratory since 2007. ISO/IEC 17025 is used to demonstrate our competence on Thrips palmi identification under a fixed scope, “Morphological identification of T. palmi adults”. The EPPO PM 7/98 guidance for entomology sets specific requirements for this process to enable the validation of morphological identification of T. palmi adults. It is concluded that of the requirements “selectivity” can be applicable for T. palmi samples and “repeatability” is very difficult to measure for the lack of fresh samples with look-alikes. T. palmi is a well-defined species, but for species which are taxonomically “in disdussion” this guidance cannot be used and validation is not an option. The validity of identifications in entomology should be focused more on confirmation of identifications instead on the validity of a work instruction.
Az új kétszintű magyar
felsőoktatási képzési rendszerben is fontos szerepet játszanak a képzési és
kimeneti követelmények. Ezek adják meg az alapot a szakindítások megítéléséhez
és az intézményi tantervek kidolgozásához. A cikkben a követelményeket hierarchikus
rendszerben látjuk jól megvalósíthatónak: az általános és a képzési ágakhoz
tartozó leírásokat követik az intézményi szintű szakleírások. Mindezek lényegi
eleme a kimeneti oldalra történő koncentrálás, a kompetenciákra építés. A cikk
utolsó részében ajánlásokat fogalmazunk meg a képzési és kimeneti követelmények