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Term: design requirements
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New CSA Group Standard Z316.8-18 on Requirements for the Design, Development and Validation of Laboratory-Developed Tests

By Editor on 1/15/2019
In April 2018 CSA group published a new National Standard of Canada developed by the Canadian Standards Association (CSA) Technical Committee, Medical Laboratory Quality Systems (Z252), which also serves as the Standards Council of Canada (SCC) Mirror Committee (SMC) for ISO Technical Committee ISO/TC212 Clinical Laboratory Testing and In Vitro Diagnostic Test Systems. IQMH expects to incorporate important details from the first edition of CSA Z316.8  Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions. into the IQMH Accreditation Requirements, which is due for full review in 2019.
Centre for Accreditation
CSA
CSA Group
design requirements
National Standard
validation of laboratory-developed tests

 

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