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An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Most Laboratory Developed Tests have been regulated under this program. [3] In 2014 the FDA started a public discussion about regulating some LDTs. [4]
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1) [1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line.
Reliability: This is a key element for users who need the product to work without fail. Conformance: Is the product made exactly as the designer intended. Customers usually associate high quality with a product that exactly meets its requirements. Durability: Durability measures the length of a product’s life. When the product can be repaired ...
Reliability-centered maintenance (RCM) is a concept of maintenance planning to ensure that systems continue to do what their users require in their present operating context. [1] Successful implementation of RCM will lead to increase in cost effectiveness, reliability, machine uptime, and a greater understanding of the level of risk that the ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
The American Society for Quality (ASQ) is a professional institute that examines the professional competency of candidates and, if found to be acceptable, awards them with official certification. This process helps to establish and maintain a minimum body of knowledge and skill level among certified engineers.
The PRISMA flow diagram, depicting the flow of information through the different phases of a systematic review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care ...