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Medical audit later evolved into clinical audit and a revised definition was announced by the NHS Executive: "Clinical audit is the systematic analysis of the quality of healthcare, including the procedures used for diagnosis, treatment and care, the use of resources and the resulting outcome and quality of life for the patient."
ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
NABL being a governmental body conducts integrated assessments with regulators such as FSSAI, EIC, APEDA, etc. Integrated assessments simplify the process of recognition, as the laboratory can get accredited and recognized by the regulator in one combined assessment instead of the separate multiple assessments which are usually needed.
EQA or proficiency testing is different from quality assurance which, in a laboratory setting, is the total process whereby the quality of laboratory results can be guaranteed. This is because relying solely on the lab-internal quality management can create a false sense of safety.
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001 .
During the review process, the submitted data undergoes verification to ensure compliance with Good Laboratory Practice (GLP) standards. Additionally, the GLP compliance status of the testing facility where the study was conducted is assessed by referring to inspection information from national GLP compliance monitoring programs.
AQC is achieved through laboratory control of analytical performance. Initial control of the complete system can be achieved through specification of laboratory services, instrumentation, glassware, reagents, solvents, and gases. However, evaluation of daily performance must be documented to ensure continual production of valid data.