Competency Assessments

Intellect’s Competency application schedules the competency event, records the results, and determines whether the regulatory or ISO requirements have been met. If the competency results do not meet the requirements, the system allows the event to be rescheduled and can trigger a nonconformance or CAPA to determine the cause of the failure.

Overall, our competency assessment app, because it’s integral to our QMS, ensures the assessment process and compliance with regulatory standards and helps labs maintain high quality and efficiency in their operations.

The workflow automates and streamlines the process, adding controls to ensure the results are completed and reviewed as required and that questionable results are investigated.

Evaluating and documenting the competency of laboratory staff is required by ISO 15189, ISO 17025, and US 42 CFR 493. Competence is defined as the ability to apply knowledge and skills to achieve intended results. Competency assessments include requirements for education, qualification, training, technical knowledge, skills and experience.

Competency is important to laboratories because it shows the staff can perform the required analysis correctly. This means is that the individuals in the laboratory are providing high quality testing. Competency assessment must be completed for every test a person performs on a predetermined schedule.