ABSTRACT

Accreditation and certification programs are a direct result of the diligent decision maker attempting to determine if laboratory data are of the required quality for the decision making process. The system that one employs to determine if a product or service is of adequate quality is otherwise known as a quality assurance program. The proposed solution, an independent third party approach, represents the consensus of a wide spectrum of individuals and organizations intimately involved in all aspects of the laboratory industry. The proposed procedure incorporates both generic and specific criteria necessary to determine the capability and ability of the evaluated laboratories. Concomitantly, the specifications and criteria are sufficiently flexible to allow an accreditation and certification system to be designed to meet the requirements of any organization requesting a laboratory accreditation evaluation. The proposed approach is capable of being implemented in a tiered fashion and has the flexibility to be designed for any organization that produces data.