''ISO 15189 Medical laboratories — Requirements for quality and competence'' is an international standard that specifies the

quality management system A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). I ...

requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization'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 medical laboratory users, including specifics on 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 The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO ...

, 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.

History

The first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025. A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management. Starting in 2010, it took four years for the

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National HIV

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to gain ISO 15189 accreditation. In 2015 Plebani ''et al'' pointed out that "despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently accredited" to ISO 15189. In 2019 the question was asked "How Does ISO 15189 Laboratory Accreditation Support the Delivery of

Healthcare Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health pro ...

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?" and answered by a systematic review. In 2021 it became apparent that the

International Health Regulations The International Health Regulations (IHR), first adopted by the World Health Assembly in 1969 and last revised in 2005, are a legally binding rules that only apply to the WHO that is an instrument that aims for international collaboration "to pr ...

was a driver for ISO 15189 accreditation when the

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provided training to EPHI staff.

External links

References

#15189 International Health Regulations {{ISO standards

History

See also

External links

References