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Medical Laboratories Accreditation In the past decade, there is a movement towards the accreditation of medical testing laboratories worldwide. Accreditation is an external audit of an applicant department¡¦s organization and quality assurance program. online university | life experience degrees There is now a trend towards accepting ISO 15189 as the standard for all accreditation bodies in order to provide uniformity of standards and cross-recognition. Examples of accreditation authorities include the CPA (College of American Pathologists) in the U.S., CPA (Clinical Pathology Accreditation) in the UK, NATA in Australia and HOKLAS for Hong Kong.
ISO 15189:2003 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 Standardisations's Technical
Committee 212 (ISO/TC 212). 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
medical laboratory to patient care.
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