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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.
New ISO 15189 Book Published to Help Clinical Lab Managers
THERE IS NOW A COMPREHENSIVE GUIDE for lab executives and lab managers interested in learning more about ISO 15189:2012, the latest version of the quality management system (QMS) for medical laboratories. It is a book titled: “A Practical Guide to ISO 15189 in Laboratory Medicine” and was publis…
Caris Life Sciences Achieves Accreditation to ISO 15189
IN DECIDING TO PURSUE ACCREDITATION TO ISO 15189: Medical Laboratories, Caris Life Sciences considered the international benefits of this designation. It was December when Caris Life Sciences of Irving, Texas, announced that it had earned accreditation to ISO 15189 from the …
Lean Used to Lay Groundwork for Lab’s 15189 Accreditation
CEO SUMMARY: Henry Ford Health System’s laboratory organization has become first in the nation to have all its laboratory sites “standardized under one source of leadership” and accredited to the standards of ISO 15189: Medical Laboratories. The journey to achieve this current state…
Labs Push to Cut Costs As Budgets, Prices Shrink
CEO SUMMARY: Cost-cutting is now the prime directive at progressive labs because nearly every laboratory organization in the United States is under sustained financial pressure. This is due to shrinking budgets for hospital labs and more aggressive price-cutting by private payers. Even Ob…
First-Mover Labs Reveal Success with Lean & QMS
CEO SUMMARY: There is good news for those clinical labs and pathology groups currently operating robust Lean, Six Sigma, and process improvement programs. The Institute of Medicine’s new report calls for all healthcare providers to rapidly transform themselves into ‘continuously learn…
QMS Helps Ontario Labs Cut Errors, Improve TAT
CEO SUMMARY: In Brampton and Etobicoke, Ontario, the hospital laboratories of William Osler Health System are using the quality management system of ISO 15189 to stay ahead of two powerful trends. Combining the QMS with Lean methods allows the labs’ management and staff to continuously …
January 30, 2012 “Intelligence: Late Breaking Lab News”
It’s a sign of the times and a warning to clinical labs and lab industry vendors. Money is short at some community hospitals— meaning bills are going unpaid. In Birmingham, Alabama, the Birmingham News reported that Cooper Green Mercy Hospital is $1 million behind in its…
Spectra Lab in Milpitas Accredits to ISO 15189
CEO SUMMARY: Spectra Laboratories, Inc., a renal-specific testing services company with labs in New Jersey and California, announced earlier this month that the American Association for Laboratory Accreditation awarded accreditation to ISO 1589 to its laboratory in Milpitas, California. I…
Pennsylvania Lab Earns ISO 15189 Accreditation
CEO SUMMARY: Clinical laboratories often promote themselves as being able to deliver quality results. But simply saying so is not the same as having an outside organization audit the laboratory to accredit its analytical processes and its other operational activities. NMS Labs in Willow G…
Our Top Ten Lab Stories Highlight Major Changes
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
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