ISO 9001 accreditation in an R&D environment - is it possible?
International Atomic Energy Agency
The Australian Nuclear Science and Technology Organisation (ANSTO) is Australia's national nuclear organisation and its centre of Australian nuclear expertise. ANSTO is in the process of replacing its 1950’s, 15 MW, high flux (up to 1015 n cm-2 s-1) reactor with a new reactor which will allow it to continue its cutting edge nuclear science and radiopharmaceutical production well into the 21st century. A ministerial requirement for licensing the facility is ISO 9001 accreditation of its quality management system. The accreditation process has been staggered at ANSTO. Individual divisions are attaining ISO 9001 accreditation separately, leading up to site-wide accreditation of an overarching ANSTO Business Management System. ANSTO Environment is the largest multidisciplinary environmental research group in Australia and the largest R & D unit at ANSTO, comprising around 150 biologists, chemists, engineers, geophysicists, meteorologists, microbiologists, oceanographers, physicists, and technicians (Fig. 1). ANSTO Environment operates and maintains a wide range of advanced nuclear and analytical facilities including three particle accelerators, a 10 MV Tandem accelerator, a 3 MV Van de Graaff accelerator and a newly acquired 2MV HVEE tandetron; a high current 50 kV Metal Vapour Vacuum Arc Ion Implantation (MEVVA) Facility; a Secondary Ion Mass Spectrometer (SIMS); and many other laboratory and field-based facilities. The objective of ANSTO Environment is to carry out a problem-focused, balanced program of strategic and applied research and development, using its nuclear science-based core expertise and closely-related techniques, to: · assist the Commonwealth Government to further its national and international initiatives, and to protect and conserve the natural environment through sustainable development; · assist industry in advancing Australia's competitive position in the world economy; · ensure that environmental monitoring of nuclear facilities is effective in assuring operational adherence to sound environmental protection principles. “Make everything as simple as possible, but not simpler” Albert Einstein In February 2000 ANSTO Environment successfully acquired ISO 9001:2000 accreditation of its quality management system and was amongst the first organisations to adopt the new 2000 revision of the international ISO 9001 standard. The new standard allows a much more flexible and less prescriptive format for quality management systems however, in the absence of examples of accreditation in the R & D area, presented a challenge in concept, definition of process, buy-in by staff and subsequent maintenance of the successful certification. The ANSTO Environment Manual of Good Management Practice  outlines our identity, our vision, our core values, our responsibilities, our operational processes and our commitment to continual improvement via internal and external review. This paper is a description and discussion of the elements, concepts and process for achieving staff buy-in in the face of initial opposition. This included identifying those necessary elements of a good management system, rejection of pejorative dogma associated with ‘Quality’ and ownership of the process by all the staff.
ANSTO, Research programs, Certification, Quality assurance, Standards, HIFAR Reactor, OPAL Reactor, Accelerators
Szymczak, R., Henderson-Sellers, A., Lowson, R. T., & Chisari, R. (2006). ISO 9001 accreditation in an R&D environment - is it possible? In Proccedings of an international conference held held in Monaco, 25–29 October 2004 organized by the International Atomic Energy Agency and co-sponsored by the Abdus Salam International Centre for Theoretical Physics, International Hydrological Programme of UNESCO, Intergovernmental Oceanographic Commission of UNESCO and the Commission Internationale pour l’Exploration Scientifique de la Mer Méditerranée, "Isotopes in Environmental Studies Aquatic Forum 2004", (pp. 613-614). Retrieved from https://www-pub.iaea.org/MTCD/Publications/PDF/CSP_26_web.pdf