Abstract
BackgroundThe variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system.ObjectivesThere is a need to compare the characteristics, suitability and applicability of quality documents in view of the increasing efforts to introduce quality management in laboratories, especially in clinical diagnostic laboratories in low income and middle income countries. This may provide valuable insights for policy makers developing national laboratory policies, and for laboratory managers and quality officers in choosing the most appropriate quality document for upgrading their laboratories.MethodWe reviewed the history of quality document development and then selected a subset based on their current use. We analysed these documents following a framework for comparison of quality documents that was adapted from the Clinical Laboratory Standards Institute guideline GP26 Quality management system model for clinical laboratory services.ResultsDifferences were identified between national and international, and non-clinical and clinical quality documents. The most salient findings were the absence of provisions on occurrence management and customer service in almost all non-clinical quality documents, a low number of safety requirements aimed at protecting laboratory personnel in international quality documents and no requirements regarding ethical behaviour in almost all quality documents.ConclusionEach laboratory needs to investigate whether national regulatory standards are present. These are preferred as they most closely suit the needs of laboratories in the country. A laboratory should always use both a standard and a guideline: a standard sums up the requirements to a quality management system, a guideline describes how quality management can be integrated in the laboratory processes.
Highlights
After the development of the plan-do-check-act cycle by Deming in the 1920s,1,2 the principles of quality management (QM) spread and became especially important in private industry
Governments forced the introduction of QM by means of laws and regulatory standards
The quality documents developed for international use included the Organization for Economic Cooperation and Development (OECD)-GLP, International Organization for Standardization (ISO) 17025:2005, ISO 15189:2007, Clinical and Laboratory Standards Institute (CLSI) GP26-A3 and the Joint Commission International (JCI) clinical laboratory standard, 2nd edition
Summary
After the development of the plan-do-check-act cycle by Deming (based on the work of Shewart) in the 1920s,1,2 the principles of quality management (QM) spread and became especially important in private industry. Requirements for regulation of processes are recorded in documents called ‘standards’. National and international quality standards were developed by several organisations. Many national and international quality standards for laboratory practice exist and quality laboratory practice has become the norm. In the case of full compliance with standard requirements a laboratory may be accredited: a formal recognition of competence and compliance to a quality standard. The variety and number of laboratory quality standards, guidelines and regulations (hereafter: quality documents) makes it difficult to choose the most suitable one for establishing and maintaining a laboratory quality management system
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