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Certifications
Abbott Informatics’ Quality mission is to develop, support and continually improve a Quality System that is flexible, accessible, compliant, executable, and simple. Our Quality Management System enables us to improve health care and laboratory workflow processes by providing high-quality, safe, and effective informatics solutions.
Abbott Informatics’ Quality Management System is established to meet the requirements of ISO 9001:2015 and ISO 13485:2016 from the prestigious BSI certification organization for the design, development, realization and implementation of laboratory information management products and medical devices. We also operate an Information Security Management System which complies with the requirements of ISO/IEC 27001:2013.
Our 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, 2021
Valid until: June 25, 2024
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, 2021
Valid until: June 25, 2024
Certificate number: FM 636368
ISO 27001:2013
Abbott Informatics is ISO 27001:2013 accredited. The scope of our certification is the information security management system for the protection of proprietary information stored within the STARLIMS platform to include procedures, records, source codes and customer PII and PHI.
Effective date: May 06, 2020
Valid until: May 05, 2023
Certificate number: IS 702430
memberships
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.
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.