Abstract
A quality management system (QMS) plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Additionally, external quality assurance or assessment (EQA) programs offer multiple benefits to laboratories: method validation, comparing of results with other laboratories, testing problem identification, accreditation requirement compliance, and credibility. In order to control the quality of the procedures, these programs are a tool to keep the laboratory procedures and every variable involved in (staff, equipment, and method) well controlled. In the frame of a quality management system, benefits from external quality assurance programs are discussed, and different available designs are reviewed. On the other hand, previous benefits will be real only if reported results for each program are analyzed in detail. Because additional advantages are achieved when the EQA results are integrated in the quality management system of the laboratory, a procedure is proposed. In addition, results from external quality assurance programs corroborate the usefulness of internal controls implemented by the laboratory as part of its quality management system.
Highlights
A quality management system (QMS) is formed by a series of coordinated activities that are carried out on a set of elements to achieve the quality of the products or services offered to the customer or user
An alternative definition of a QMS is through the meaning of each word separately, according to the ISO 9000:2015 quality management system—fundamentals and vocabulary:
The quality management system model generated by Clinical and Laboratory Standards Institute (CLSI) is based on 12 key elements and is fully compatible with ISO standards for laboratories [1]
Summary
A quality management system (QMS) is formed by a series of coordinated activities that are carried out on a set of elements to achieve the quality of the products or services offered to the customer or user. In the case of a laboratory, the accuracy, reliability, and timeliness of the analytical results reported define its quality, and all aspects of analytical operations should be controlled [1]
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