In January 2003, the International Organization for Standardization (ISO) published the world’s first harmonized clinical laboratory practice standard.
Laboratories wishing to have some verification of their quality and performance have for years used ISO 17025 (which included general requirements for the competence of calibration and testing laboratories).
While this standard provided a generic framework for a laboratory quality management system, essential elements relative to clinical laboratories were missing. Consequently, the laboratory community approached the ISO Secretariat to create a standard specifically for the unique requirements of clinical laboratory practice.
The standard that was published is known as ISO 15189 (Medical laboratories – Particular Requirements for Quality and Competence). Since its publication this standard has gained rapid and widespread acknowledgement and adoption in many countries
In 2007, the second edition of ISO 15189 was published, with the intent to align it further with ISO 17025.
• Laboratories accredited to ISO 15189 are formally recognized to be competent, thus providing a ready means for customers to identify and select medical testing and clinical analysis services.
• Compliance to ISO 15189 aids the laboratories to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence.
• Compliance to ISO 15189 is an effective marketing tool for medical and clinical laboratories and a passport to submit tenders to contractors that require independently verified laboratories.
ISO 15189's main objective is to allow laboratories to organize their operational procedures efficiently, meet the expectations of their clients and improve their service.
The ISO 15189 standard is divided in two major parts:
• Management requirements: generic requirements related to quality management systems.
• Technical requirements: specific requirements related to activities carried out by clinical laboratories. The figure below displays the main activities covered by ISO 15189.
In December 2010, we passed the initial inspection of EGAC and SWEDAC organization for ISO 15189 accreditation. This inspection involved the clinical chemistry area (chemistry, endocrinology), virology unit, hematology unit and general laboratory practice. The inspection team included medical staff from Egypt and Sweden who are highly qualified persons in medical laboratory field.
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