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 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.
Software solutions designed specifically for medical
laboratories can aid in achieving ISO15189 certification. In particular,
document control software can help by improving turnaround time (TAT) for
document reviews, increasing efficiency of staff and improving overall quality.
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