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Certifications
Abbott Informatics’ commitment to quality is unprecedented in the field of Laboratory Information Management Systems (LIMS). The approach taken by most of the leading suppliers of LIMS is to attempt to follow the general principles of ISO-9001 compliance guidelines for quality management systems; Abbott Informatics quickly ascended to a leadership role in quality by obtaining actual certification as ISO-9001 compliant from the prestigious BSI certification organization.
Abbott Informatics raised the bar to an unprecedented level by also obtaining ISO-13485 certification from BSI. What this means is that our systems are held to the stringent standards of medical devices, and to our customers, that commitment to quality is manifested in strict adherence to ISO-13485 in our software systems, our management processes, our customer service, our issue resolution processes—virtually every aspect of our company.
Abbott Informatics’ unparalleled investment in quality means that our current and prospective customers can rest assured that quality is our guiding principle.
Accreditations
ISO 13485:2016
Abbott Informatics is ISO 13485:2016 accredited. The scope of our certification is the design, manufacture, distribution, installation and servicing of Laboratory Information Management Systems software for the medical device industry.
Effective date: June 26, 2018
Valid until: June 25, 2021
Certificate number: FM 636367
ISO 9001:2015
Abbott Informatics is ISO 9001:2015 accredited. The scope of our certification is the design, manufacture, distribution, installation and servicing of Laboratory Information Management Systems software for various industries.
Effective date: June 26, 2018
Valid until: June 25, 2021
Certificate number: FM 636368
memberships
GSA IT SCHEDULE 70
Abbott Informatics is GSA Schedule 70-certified for forensics and public health industries. IT Schedule 70 is the largest, most widely used acquisition vehicle in the federal government. Schedule 70 is an indefinite delivery/indefinite quantity (IDIQ) multiple award schedule, providing direct access to products, services, and solutions from more than 5,000 certified industry partners.
Association Of Public Health Laboratories (APHL)
APHL collaborates with laboratory and public health partners to assure effective surveillance, detection and response to health threats. It works closely with federal agencies, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Food and Drug Administration, and the Environmental Protection Agency, to develop and execute national health initiatives. During public health emergencies, APHL operates as a coordinating center for laboratory response.
American society for quality
Abbott Informatics is a member of the world’s leading authority on quality, the American Society for Quality.
International society for pharmaceutical engineering
Abbott Informatics is a member of the International Society for Pharmaceutical Engineering (ISPE). ISPE is a global, not-for-profit membership organization that provides education, training, and technical publications to pharmaceutical manufacturing professionals.
ALLOTROPE FOUNDATION
Abbott Informatics is proud to be an Allotrope Foundation member. The foundation’s vision is to create an intelligent, automated, and integrated analytical laboratory that allows scientists to focus on science rather than searching for assembling, transforming, and reporting data.