CEN/TC 140/WG 9 - Use of external quality assessment schemes
To elaborate standards for WI 00140045.
Use of external quality assessment schemes
To elaborate standards for WI 00140045.
General Information
Frequently Asked Questions
CEN/TC 140/WG 9 is a Working Group within the European Committee for Standardization (CEN). It is named "Use of external quality assessment schemes" and is responsible for: To elaborate standards for WI 00140045. This committee has published 1 standards.
CEN/TC 140/WG 9 develops CEN standards. The scope of work includes: To elaborate standards for WI 00140045. Currently, there are 1 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
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