ABSTRACT

Performance evaluation and monitoring are related to defining the laboratory’s ability to produce analytical data of a quality sufficient to meet the requirements of the data’s end use. However, these procedures are usually not fully implemented in conjunction with baseline capability assessments. In order to conduct the in-depth, third-party reviews of data that are appropriate to the purchaser’s use of the data, quality specifications and requirements and the associated data certification criteria must be determined. Third-party organizations can be used to provide both accreditation and certification services. The most critical aspects to be maintained for both inspection of process for capability (accreditation) and inspection of products for conformance to specifications (certification) are competence and integrity. It is incumbent upon the third-party organizations to perform the accreditation and certification processes in the most competent, unbiased manner possible both to ensure the third-party organizations’ credibility and to show the client organizations that the assessments have validity.