ABSTRACT

Laboratory accreditation demonstrates a laboratory’s competency to perform certain processes and tasks consistently. Unfortunately there are many different accreditation programs. Each type of lab-research, testing, or manufacturing-must comply with certain quality assurance regulations. A Laboratory Information Management System (LIMS) must meet the requirements of the laboratory’s quality assurance programs. Some of the better-known regulations and standards for ensuring quality are International Standards Organization (ISO) Standards, US Environmental Protection Agency (EPA) Standards, and US Food and Drug Administration (FDA) Standards.