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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.
It is built to connect systems in a laboratory, such as laboratory information management systems, electronic lab notebooks, chromatography software and laboratory devices such as balances, pipettors and various other analytical instruments. Enhancing the first standard SiLA 1.x by adopting proven concepts and applying already existing open ...
A functional specification is a kind of requirement specification, and may show functional block diagrams. [citation needed] A design or product specification describes the features of the solutions for the Requirement Specification, referring to either a designed solution or final produced solution. It is often used to guide fabrication ...
This category is for articles about technical specifications, or "Specs". Pages in category "Technical specifications" The following 27 pages are in this category, out of 27 total.
Laboratory Data Model (LAB) The Lab standard is used for the exchange of laboratory data between labs and CROs; Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) [6]
The primary types of technical standards are: A standard specification is an explicit set of requirements for an item, material, component, system or service. It is often used to formalize the technical aspects of a procurement agreement or contract. [2]
Starting in 2010, it took four years for the Kenya National HIV Reference Laboratory to gain ISO 15189 accreditation. [ 4 ] In 2015 Plebani et al pointed out that "despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently ...
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.