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Laboratory Quality Standards and Their Implementation
The objektive of this document on Laboratory Quality Standards is for it to be used as a guidline for evaluation,development and implementation of quality systems and standards for health laboratory servies. The internationally accepted standards of the International Standards Organization (ISO) 15189 and ISO 17025 have stringent requirements and can usually be met only by laboratoies either at the national level or by spcialized reference laboratories. They are often very resqurce-intensive and many countries find it difficult to implement them. Since laboratories in developing Member States are at different levels with respect to quality,the standards outlined in this document,while based on the ISO standards,have beensimplified to encourage member States to follow them. A flexible step-wise approachis encouraged so thatthese guidelines become a stepping-stone to achieving the ISO standards. Establishing and maitaining Laboratory quality standards are essential. This document presents a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. Suggestions are also provided on ways to implement them. They are important for several reasons,including ensuring the quality and traceability of patients' results supporting clinical and public health decision-making procuring equipment use of standard techniques and reagents for sharing documentation training programes quality assurance meeting requirements for reimbursement for national insurance schemes and compliance with national or intenational accreditation and licensing systems. This document will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requrirements set,and it is hoped that eventually laboratories can improve their systems and aspire to meet ISO 1589 ina logical and step-bay-step manner.
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