Quality management

ISO 9001:2015 and EN ISO 13485:2016 certification

The entire AO Research Institute Davos (ARI) is certified according to ISO 9001:2015 and we have good reason to be proud of this. ARI is one of very few academic research organizations to have achieved this certification.

Additionally, the biomechanical services and concept development focus fields are certified according to EN ISO 13485:2016, which demands a much higher level of documentation and traceability.

 

 

Good Laboratory Practice (GLP) certification for our Preclinical Facility

High-quality work is important for successful research. ARI works hard to ensure the highest quality in all 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 in October 2018. ARI is one of only two academic institutes certified for GLP in Switzerland.

These accreditations demonstrate ARI's commitment to fulfilling the highest standards in research.

The 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 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 the 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 the FDA.

 

Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)

ARI's Preclinical Facility has been granted accreditation from AAALAC international, 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 ethics.

More than 870 companies, universities, hospitals, government agencies, and other research institutions in 36 countries worldwide 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. ARI is one of 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 Institutional Animal Care and Use Committee (IACUC) for ARI. The IACUC is a self-regulating entity that, under US 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.

Contact

Ulrich Bentz

Quality Manager and Purchasing Agent

X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm