ISO 15189 accreditation
ISO 15189 accreditation is the gateway to the effective use of the quality management system (QMS) that is an integral part of all ISO standards. These standards range from the basic ISO 9001 to ISO 15189–Medical Laboratories and ISO 17025–Competence of Testing and Calibration Laboratories.
ISO 15189 specifies the quality management system requirements particular to medical laboratories. ISO 15189 is one of the fastest growing international quality standards in the world.
Clinical laboratories and pathology groups experience many benefits by achieving ISO 15189 accreditation. Use of quality management systems by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.
As explained by MedLab, ISO 15189 accreditation also reduces risks, encourages the sharing of best practices and stimulates innovation. For payers and healthcare providers, accreditation is a tool that provides assurance that clinical lab services are safe, reliable and good value for patients. It also provides a mechanism for measuring quality improvements and supporting consistency.
For patients, accreditation gives confidence that the services they receive are competent and safe, which can be a significant selling point for a medical laboratory.
One of the main benefits of ISO 15189 accreditation is that it is globally recognized. A series of Mulitlateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 different economies across the world, representing 95% of global GDP.
The accreditation to ISO 15189 is in addition to CLIA ‘88 accreditation and does not replace it.
Anyone can self‐declare competence in offering ISO 15189 accreditations. However, organizations such as the American Association of Laboratory Accreditation (A2LA), the College of American Pathologists (CAP) are among the leading accreditors for ISO 15189 in the U.S.
Accreditation is also done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies.
A2LA offers accreditation to clinical testing laboratories in 34 specialties and subspecialties. A2LA is also the only accreditor in the United States that is recognized internationally.
The CAP says it is the largest and most experienced accreditor in the world in the specialty of medical laboratory accreditation, leading and enhancing laboratory accreditation for more than 50 years. Pathologists from CAP have been instrumental in crafting the ISO 15189 standard.
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