What is AABB Accreditation? “A connected community dedicated to advancing transfusion medicine and biotherapies. From donor to patient. From lab to bedside.” This is a tagline adopted by the American Association of Blood Banks (AABB). The AABB is an international, non-profit association that comprises and represents those involved in the fields of cellular therapies and…
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What is the ISO 15189 Accreditation? International Organization for Standardization (ISO) 15189 is an international standard for medical laboratories that is closely based on ISO/IEC 17025 and ISO 9001. The accreditation assists labs in developing quality management systems (QMS), assessing their competence/performance, and ensuring their operations meet industry and legal standards for patient safety. It…
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ISO 13485: Quality Management System for Medical Devices Unscalable and unreliable medical devices can heavily impact work in medical areas, which can affect public health. To mitigate the inherent risks in some medical tools and equipment, there needs to be some sort of quality management system (QMS) in place that’s enforced. This is where the…
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What is an ISO 17025 Accreditation? In 1999, the International Organization for Standardization (ISO) developed and issued ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. Also known as the ISO 17025 accreditation, this ISO standard must be met by labs in order to be deemed “technically competent”. Without the accreditation, regulatory…
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Laboratory Testing Regulations: GMP vs. GLP Do you ask yourself before consuming any packaged food or medicine if they are safe for your health? As the average consumer, we might not always question the safety of what we use or eat. That’s because we trust the Food and Drug Administration (FDA) to ensure quality standards…
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