ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
Medical laboratory services are essential to patient care and therefore have to be avail able to meet the needs of all patients and the clinical personnel responsible for the care of those patients.
This International Standard can be used by medical laboratories in developing their
quality management systems and assessing their own competence. It can also be used
for confirming or recognizing the competence of medical laboratories by laboratory
customers, regulating authorities and accreditation bodies.
1. ISO 15189 Implementation improves laboratories testing outcomes and mitigates risks for both Technical competence & Management system requirements.
2. ISO 15189 Implementation identifies strengths and gaps in your programs and processes.
3. ISO 15189 Implementation promotes communication and staff empowerment across SMC.
4. ISO 15189 Implementation fosters a culture of quality and safety in laboratories.
5. ISO 15189 Implementation demonstrate its ability to consistently provide services that meets customer & applicable statutory and regulatory requirements.
6. ISO 15189 Implementation results in continual improvements by implementing to enhance patient satisfaction which will boost international opportunities for providing services.
7. ISO 15189 Implementation results in Cost-saving, improved team morale, legally compliant, globally recognized by adaption of ISO standards by meeting regulatory requirements.
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