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Language: English

National Laboratory Quality Policy Manual for South Sudan

[Quality Management Policy Manual for South Sudan]

This laboratory quality policy manual guides the implementation of the requirements of ISO-15189:2012 in South Sudan to provide a comprehensive reference on Laboratory Quality Management Systems for all stake-holders in the health laboratory process.

SUMMARY

The National Laboratory Quality Policy Manual for South Sudan aims to improve and maintain accuracy, timeliness, and reliability of laboratory results and products nationwide. The manual contains policy on all components required to ensure effective planning, operation, and control of key QMS processes in all laboratories. Overall, this accreditation process aims to provide objective documentation to confirm that each laboratory has the ability to detect, identify, and promptly report diseases of clinical and public health significance.

The Ministry of Health of the Republic of South Sudan developed this manual in collaboration with numerous partners, including ICAP, along with funding from the Centers for Disease Control and Prevention (CDC). This manual is based on requirements from ISO-15189:2012—the International Organization for Standardization’s requirements for quality and competence in medical laboratories—along with the Clinical and Laboratory Standards Institute (CLSI)’s GP26-A3, the Maputo Declaration of 2008, and general requirements for competency in testing and calibrating laboratories. The document is available in English as a PDF.