At Assured Bio, we know that data from our analyses will be used to inform major decisions affecting healthcare facilities, homes, businesses, and new product development. Because these decisions often involve human health and potentially high-cost remediation procedures, ensuring the quality of the data we produce is our top priority. In addition to strict adherence to our own quality management system, Assured Bio is an accredited laboratory with certifications spanning a wide range of environmental microbiology analyses.
Being accredited means that we have demonstrated compliance to certain quality requirements and are recognized by an accrediting body. These requirements typically involve standards for traceability, control of documents and records, personnel training, instrument verification and calibration, sample handling, and quality control procedures, to name a few. In recent years, ISO 17025 has adopted a “risk-based thinking” approach to quality management. For Assured Bio, this means we shape our quality system within a framework of continually seeking for opportunities for improvement while minimizing risks that would negatively impact the quality of our results.
In order to demonstrate compliance to third party accrediting bodies, we participate in regular assessments of our quality system. Recently, Assured Bio completed one of the regular biennial assessments to the ISO/IEC 17025:2017 international standard by AIHA Laboratory Accrediting Programs, LLC. For the first time, due to Covid-19 precautions, the assessment was completely remote and performed via a video conferencing platform. The assessment took place over a 3-day period and involved a rigorous audit of Assured Bio’s quality management system.
In addition to ensuring all of our required documentation is current, the site assessor chose a number of reports published by Assured Bio and performed a detailed traceability assessment. This means that datasheets for each project analyzed at Assured Bio must include references to all personnel, equipment, media, reagents, and reference cultures involved which then must be traceable to training documentation, verification and calibration records, quality control logs, and certificates of analysis.
After the assessment was complete, the site assessor discussed with management potential areas for improvement. Assured Bio received high marks on our quality system with only minor nonconformities to address before receiving full approval. Regular assessments like this one allow Assured Bio to not only maintain our accreditation status, but to find opportunities to improve to provide the best quality services possible for our clients.
To learn more about Assured Bio’s full list of certifications, please see our Accreditations and Certifications page.