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  2. Laboratory quality control - Wikipedia

    en.wikipedia.org/wiki/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 measurement system reproduces the ...

  3. External quality assessment - Wikipedia

    en.wikipedia.org/wiki/External_quality_assessment

    This is because relying solely on the lab-internal quality management can create a false sense of safety. Laboratories are instructed to treat proficiency testing samples in the same way as normal patient samples. [1] For a laboratory, gaining and keeping the ISO 17025 accreditation status is of high commercial importance.

  4. Analytical quality control - Wikipedia

    en.wikipedia.org/wiki/Analytical_quality_control

    Quality control begins with sample collection and ends with the reporting of data. [4] 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.

  5. 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 ...

  6. Westgard rules - Wikipedia

    en.wikipedia.org/wiki/Westgard_Rules

    They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control. [1] They are plotted on Levey–Jennings charts , wherein the X-axis shows each individual sample, and the Y-axis shows how much each one differs from the mean in terms of standard deviation (SD).

  7. Verification and validation - Wikipedia

    en.wikipedia.org/wiki/Verification_and_validation

    Clinical laboratory medicine: ISO 15198:2004 Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer; Engineering. Engineering in general Engineering validation test; Civil engineering. Buildings – Roads – Bridges – Health care: example [67]

  8. Individualized Quality Control Plan - Wikipedia

    en.wikipedia.org/wiki/Individualized_Quality...

    The Individualized Quality Control Plan (IQCP) is a quality management system under the US Clinical Laboratory Improvement Amendments (CLIA) federal regulatory standards. It is designed to enable regulated medical laboratories to manage the frequency of their quality control .

  9. Clinical Laboratory Improvement Amendments - Wikipedia

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

    Quality control records: 5 years [24] Donor and recipient records: 10 years [24] Records of indefinitely deferred donors: Indefinitely [24] Wet tissues Until report is completed [23] or 2 weeks thereafter [24] Proficiency testing records and quality management/quality control records 2 years [23] Discontinued procedures 2 years [23]