An overview of ISO 15189

ISO 15189: 2012 Standard " Medical laboratories — Requirements for quality and competence" was published on November 1, 2012, replacing ISO 15189: 2007.
KIS recognizes that "Quality is that give effectiveness for customers". By dint of that, to ensure "the customer rights", KIS commits to customers that "KIS consultancy services completed when customers receive certificates".
I. What is ISO 15189?
1. ISO 15189: 2012 (equivalent to the Vietnam national standard TCVN 15189: 2014) is a standard specifying competent and quality requirements for medical laboratories. This standard is created by basing on the requirements of ISO / IEC 17025 and ISO 9001; besides, it is added specific requirements of quality assurance in the medical testing.
2. This standard is used when medical laboratory needs to establish a quality management system to improve its technical competence for accreditation. If the laboratory wishes improved its service quality and customer’s satisfaction, it is necessary to apply the additional ISO 9001 to integrate both the technical competence and the service quality.
3. ISO 15189 contains 15 management requirements which are similar to ones of ISO / IEC 17025 or management system requirements in ISO 9001 and 08 related technical requirements for quality assurance in testing activities such as: competence and skills of testing staff; control of environmental conditions; control of testing equipments; preparation before testing; control the testing process ...
4. Medical testing is an essential stage in the process of diagnosis and treatment for patients. The application of ISO 15189 will ensure to provide an accurate and reliable test results that seem as a basis for promoting recognition of test results between hospitals or clinics and so on.
II. Subject of application
Laboratory/ Department of laboratory at the hospital;
Authorities used to assess the competence of medical laboratory/ medical testing deparment;
Accreditation bodies use to evaluate and accredit the competence of medical laboratory/ medical testing department.
III. Benefit
Enhance the accuracy and reliability of test results in diagnosis and treatment at hospitals and health clinics;
Improve the quality management capacity of medical laboratories;
Create conditions for hospitals and health clinics to consider and utilize test results of other places;
Is a reliable subject for activities of health assessment, forensic, etc.
As a subject in order to participate in evaluation and accreditation between laboratories in the world; and by the time, create environment to improve the professional skills of the medical staffs, doctors, technicians of the laboratory, etc.
IV. Contact
For full advice on the requirements of ISO 15189: 2012, please contact:
Hotline: 0942 99 66 88;

Translator: KIS Administration

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