Avram supported CDC in its goal to obtain ISO 17025 accreditation for all US laboratories.
PROJECT MANAGEMENT AND EVALUATION FOR INTERNATIONAL STANDARDS ORGANIZATION (ISO) 17025 ACCREDITATION OF CDC LABORATORIES
Program Management, Laboratory Expertise, Quality Systems, Technical Writing
Centers for Disease Control
The Office of the Associate Director for Laboratory Safety and Science (OADLSS) was established by the Center for Disease Control and Prevention (CDC) as a provider of agency-level oversight of safety and quality for all CDC laboratories. To ensure the highest level of safety and standards, the CDC sought external accreditation in the International Standards Organization (ISO) in five infectious disease laboratories. As a proven source of technical assistance and operational support, Avram lent its experience and expertise in support of implementing the internationally recognized standards of quality assurance. This initiative highlights Avram Corporation’s effective project management, understanding of quality systems, technical support and program evaluation.
What we accomplished:
Project planning and monitoring: tracked all tasks and activities relating to the external accreditation process for targeted pilot CDC laboratories. These activities included initial gap assessments, creation of a central quality management system (QMS) compliant with ISO and Clinical Laboratory Improvement Amendments (CLIA), evaluations at every stage of implementation, and the development of technical manuals and guides.
Technical Support: Avram provided subject matter expertise in ISO/IEC 17025 and CLIA compliance throughout the CDC external accreditation process. Avram deliverables on this project included the development of process documents, standard operating procedures, and work instructions for CDC laboratories, maintaining all document inventory associated with the external accreditation process, and providing technical consultations for the pilot laboratory facilities.
Quality Control: As part of the program management support executed by Avram, template procedures and best practice process documents for ISO compliance were created. This included creation of systems forfeedback, non-conformance management, investigation management, document control, record control, and uncertainty budget. These systems were applicable for future state assessments of quality management systems for each laboratory branch. Avram provided evaluations of the project pilot process, needs assessments, strategic planning support, and program reviews.