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ISO 15189
ISO 15189 (Medical laboratories — Particular requirements for quality and competence) specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardizations’s Technical Committee 212 (ISO/TC 212).
ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.
The International Organization for Standardization has released three versions of the standard. The first two were released in 2003 and 2007. In 2012, the organization released a revised and updated version of the standard, ISO 15189: 2012 (Medical laboratories – Requirements for quality and competence). The standard is often referred to without the version, simply as “ISO 15189.”
ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab’s role in the education and training of health care staff.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the clinical laboratory to patient care.
ISO 15189 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.
Software solutions designed specifically for medical laboratories can aid in achieving ISO 15189 accreditation. In particular, document control software can help by improving turnaround time (TAT) for document reviews, increasing efficiency of staff and improving overall quality.
ISO 15189 is one of the fastest growing international quality standards in the world. Twenty-three countries around the world adopted the standard within a year of publication, and by 2013, the standard was adopted by medical laboratories in over 60 countries.
Lean Used to Lay Groundwork for Lab’s 15189 Accreditation
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Ohio Lab Offers Lessons Learned from CAP 15189
CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohi…
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”
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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…
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