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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).
Fundamentally healthcare and hospital accreditation is about improving how care is delivered to patients and the quality of the care they receive. Accreditation has been defined as "A self-assessment and external peer assessment process used by health care organisations to accurately assess their level of performance in relation to established standards and to implement ways to continuously ...
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
CLSI participates in the development of international standards as the Secretariat of ISO Technical Committee (TC) 212, clinical laboratory testing and in vitro diagnostic test systems. This responsibility was delegated to CLSI by the American National Standards Institute (ANSI), an ISO member body. CLSI also serves as the administrator for the ...
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
Healthcare Quality Improvement Partnership (HQIP) Promoting quality for better health services, HQIP is funded by the Department of Health to increase the impact that clinical audit has on healthcare quality in England and Wales. Clinical Audit Tool. PCS Clinical Audit Tool (CAT) is a population reporting enhancement to the leading GP Clinical ...
The International Society for the Quality in Healthcare (ISQua) is the umbrella organization responsible for accrediting the Joint Commission accreditation scheme in the US and Accreditation Canada International, as well as accreditation organizations in the United Kingdom and Australia. [1]
The history of testing, inspection and certification services spans back several centuries. In the late 19th century, following the advent of the Industrial Revolution and the considerable risks involved with high-pressure steam boilers, specialized institutions emerged across Europe which carried out periodical inspections of such vessels to assess their overall condition as a precautionary ...