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  2. Clinical Laboratory Improvement Amendments - Wikipedia

    en.wikipedia.org/wiki/Clinical_Laboratory...

    Jeremy Gruber, Council for Responsible Genetics In the US, newborn screening (NBS) is mandated in all states, though parents may decline the screening process based on religious beliefs or philosophical reasons in some states. Few parents opt of the program due to health concerns, and a lack of awareness of the ability to opt-out. After the initial testing is complete, the residual dried blood ...

  3. ISO 15189 - Wikipedia

    en.wikipedia.org/wiki/ISO_15189

    ISO 15189. ISO 15189 Medical laboratoriesRequirements 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).

  4. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.

  5. Laboratory quality control - Wikipedia

    en.wikipedia.org/wiki/Laboratory_quality_control

    Laboratory quality control. Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory. Quality control (QC) is a measure of precision, or how well the ...

  6. ISO/IEC 17025 - Wikipedia

    en.wikipedia.org/wiki/ISO/IEC_17025

    ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method. In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant ...

  7. Clinical and Laboratory Standards Institute - Wikipedia

    en.wikipedia.org/wiki/Clinical_and_Laboratory...

    The Clinical and Laboratory Standards Institute(CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community. History.

  8. Clinical quality management system - Wikipedia

    en.wikipedia.org/wiki/Clinical_Quality...

    Clinical quality management systems ( CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...

  9. Analytical quality control - Wikipedia

    en.wikipedia.org/wiki/Analytical_quality_control

    Analytical quality control. Analytical quality control ( AQC) refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits of precision. [1] Constituents submitted to the analytical laboratory must be accurately described to avoid faulty ...