ISO 9001:2008 and ISO 13485:2012 Certification
The entire AO Research Institute Davos is certified according to ISO 9001:2008. We have good reason to be proud! The Institute is one of the very few academic research organizations which has achieved certification.
Additionally, the focus fields Biomechanical Research & Development and Concept Development are certified as medical device manufacturer (PDF, 82 KB ) according to EN ISO 13485:2012, which demands a much higher level of documentation and traceability.
What does this ISO Standard demand of an organization?
First of all, the introduction of a Quality Management System brings about the need to define quality. There is no single definition for "quality" except to know that the "customer" or end-user is satisfied with the "result". Thus the management itself of the certified institution must define its outcome, its customers and determine their satisfaction. In this process, the management has to consider the mission and goals of the institute as well as the environment. In the AO Foundation, this means that a sound scientific basis must be established for new technology and published in the appropriate journals. The depth of research should be such that the result can be related to the original technology and that the actual clinical questions are answered.
Measuring the quality of the work performed is more difficult, because the result of research usually is a somewhat better understanding of a not yet fully unveiled reality, a step forward in the (sometimes uncertain) direction of progress. The measures used in the Research Institute are those of all academic institutions: the number and quality of the publications, patents and book chapters, the number and amount of extramural fundings, the number of dissertations promoted (PhD's, MPhil's, M.Sc's, Diplomas, medical theses), the number of presentations (invited, submitted, oral or poster), the number of scientific awards, the number of reviews made in respected journals or grant agencies, memberships of journal editorial and review boards, memberships of executive committees of national and international societies. Other means to measure academic performance include reviews by external peers. Performance measurement also includes management reviews, which means that not only people, but also the internal processes themselves must be monitored and their function evaluated regularly. This helps to constantly improve or keep the quality of the institute's work at the highest possible level.
GLP (Good Laboratory Practise) certification of ARI Preclinical Facility
High quality work is important for successful research. The AO Research Institute Davos (ARI) is working hard to ensure high quality in our research projects. Therefore, we are very proud that we received the official Statement of GLP Compliance from the Federal Office of Public Health, of the Swiss Confederation through Swissmedic (Swiss Agency for Therapeutic products) together representing the Swiss GLP monitoring authorities this week. The ARI is one of only two academic institutes certified for GLP in Switzerland.
All these accreditations demonstrate ARI's commitment in fulfilling the highest standards in research.
GLP is an internationally recognized quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
We are now able to conduct preclinical studies with potential customers and any partners of the AO Foundation network in the only Swiss GLP and AAALAC accredited institute. This is of special importance, for future approval of medical devices by the FDA, since at the moment FDA has a new guideline in review (General considerations for animal studies for medical devices) for preclinical studies, which will make GLP and AAALAC virtually mandatory for any submission to FDA.
Association for Assessment and Accreditation of Laboratory Animal Care
The Preclinical Facility has been granted AAALAC accreditation. AAALAC International stands for the Association for Assessment and Accreditation of Laboratory Animal Care and is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. We are extremely proud of this accreditation as it clearly defines ARI as having the highest possible animal care ethos.
More than 870 companies, universities, hospitals, government agencies and other research institutions in 36 countries world-wide have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research. The AO Research Institute is one of only three accredited institutions in Switzerland and one of the few academic Research Institutes in Europe, being currently no other in Switzerland. In addition AAALAC has accepted the TVKGR (Tierversuchkommission GR) as the IACUC for the ARI. The Institutional Animal Care and Use Committee (IACUC) is a self-regulating entity that, according to U.S. federal law, must be established by institutions that use laboratory animals for research or instructional purposes to oversee and evaluate all aspects of the institution's animal care and use program.
Ulrich Bentz, Quality Management