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Operations standards and safety
Successful 2013 renewal audit of AO Research Institute From April 10 to 11, 2013, two external auditors from the SQS (Swiss Association for Quality and Management Systems; www.sqs.ch) visited ARI two full days for the renewal audit of the institute. ARI has received the renewal of the certification for 3 years without any non-conformities requiring immediate actions. Having held several open discussions with staff members and management, the auditors were impressed by the levels of commitment and knowledge. The entire AO Research Institute is certified according to the international standard ISO 9001:2008. The Biomedical Services Program is additionally certified as a medical device manufacturer according to ISO 13485:2003. ARI is one of the very few academic research organizations to have achieved this certification. AAALAC certification of Preclinical facility The Preclinical Facility was accredited by AAALAC in early 2013. The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. AO Research Institute Davos is one of 3 accredited institutions in Switzerland, and the only accredited academic Research Institute in Switzerland. GLP accreditation The aim to get GLP accreditation in 2015 was put on hold, after the first meeting of the ARI Advisory Committee in December 2013. The following main reasons led to this decision. Firstly our main industrial partner has not started any new study in the Preclinical area since 2 years. Secondly all related FDA guidance and regulation documents are only in draft status and not yet binding. Last but not least, most of the studies we conducted until today would not fall under the new regulations. Nevertheless a first study is currently still running and will be finished GLP-like.
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