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ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212).
The Department of Trade and Industry (DTI) had recognised the need to create a single national accreditation system as long ago as 1993, and the establishment of such a system was approved by Cabinet in late 1994. During 1995 the newly independent NLA was contracted to create the South African National Accreditation System (SANAS).
ISO 15188:2001 Project management guidelines for terminology standardization; ISO 15189:2012 Medical laboratories – Particular requirements for quality and competence; ISO/IEC 15200:1996 Information technology - Adaptive Lossless Data Compression algorithm (ALDC) ISO/IEC 15205:2000 SBus - Chip and module interconnect bus
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1]
Instead of being able to calmly focus on her chemotherapy treatment, Arete Tsoukalas had to spend hours on the phone arguing with her insurer while receiving infusions in the hospital.
Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration have been added to many LIMS, enabling the realization of translational medicine completely within a single software solution. Additionally, the distinction between LIMS and LIS has blurred, as many LIMS now also fully support comprehensive ...
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related to: iso 15189 quality management system