Assessment is an important element of the quality system essentials. It is the means for determining the effectiveness of a laboratory’s quality management system through internal and external audits, and evaluation of performance in an external quality assessment (EQA) programme. This chapter is focused on descriptions of internal and external audits
An assessment can be defi ned as the systematic examination of some part (or sometimes all) of the quality management system to demonstrate to all concerned that the laboratory is meeting regulatory, accreditation and customer requirements. Central-level laboratories are generally familiar with assessment processes, as most will have had some kind of assessment by an external group
Why perform an
Assessments are performed in a variety of ways and under a number of different circumstances. The International Organization for Standardization (ISO) standards are very specific about assessment requirements, and the term “audit” is used instead of “assessment”. The terms may be considered interchangeable, and local usage will determine the actual terminology required. The ISO definition for audit is a “systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which required criteria are
An assessment, or audit, allows the laboratory to understand how well it is performing when compared to a benchmark or standard. Any gaps or nonconformities in performance can show if the policies and procedures that the laboratory has set require revision or are not being followed. A laboratory needs this information about its performance for:
planning and implementing the quality system
monitoring effectiveness of the quality system
correcting any deficiencies that are identified
working toward continuous improvement.
Assessments conducted by groups or agencies from outside the laboratories are called external audits. They can include assessments for the purpose of accreditation, certification or licensure. Another type of assessment that laboratories can utilize is the internal audit, where staff working in one area of the laboratory conduct assessments on another area of the same laboratory. This provides information quickly and easily on how the laboratory is performing and whether it is in compliance with policy requirements.