|ISO 15189 is a standard that specifying Quality and
Competence Requirements for Medical Laboratories.
It was originally proposed in 1995 and was first wrote
in November 1999 as an article entitled Quality
Management in the Medical Laboratory and the article
examined the increased use of Quality Systems Management
in Medical (clinical) Laboratories.
The development of the standards was intended to
harmonize Quality Management procedures and regulations
for medical laboratories to help improve the quality of
ISO 15189 outline
This standard, based upon ISO / IEC 17025 and ISO 9001,
provides requirements for competence and quality that
are particular to medical laboratories.
Medical laboratory services are essential to patient
care and therefore have to be available to meet the
needs of all patients and the clinical personnel
responsible for the care of those patients. Such
services include arrangements for requisition, patient
preparation, patient identification, collection samples,
transportation, storage, processing and examination of
clinical samples, together with subsequent validation,
interpretation reporting and advice, in addition to the
considerations of safety and ethics in medical
Who supposed to have ISO 15189
This standard emphasizes on competence requirements to
be used by government agencies and professional
organizations of medical laboratories.
Why medical laboratories need ISO 15189
The progress of scientific medical knowledge has
resulted in the need for increasingly precise and
frequent information on the health status of actual and
potential patients. The ISO 15189 is reflected by the
reliability of medical research and treatment that
depends on the medical laboratory. Hence, medical
laboratories react to these demands by organizing the
operation along Quality Management rules and the needs
are become apparent: -
- Potential and actual patients are increasingly mobile.
The system to collect medical data on these individual
therefore must operate according to the same standards
independent from their geographic location.
- The mobility of modern society allows dangerous
infectious diseases to easily and quickly spread in
different geographic areas. The fast and unequivocal
identification of diseases and of infected individuals
by different laboratories in different areas requires
- Requirements for quality improvements and cost control
are similar in medical laboratories around the world.
The application of common standards will facilitate the
exchange of experiences and the introduction of
- For cost reasons IVD to a large extent are developed and
produced on a global scale. To maximize the safety and
efficiency of these devices, the operations of medical
laboratories should follow equally global standards.
ISO 15189 Vs ISO 9001
ISO 15189 is a standard that brings together the Quality
System requirements of ISO 9001 that emphasized on
Quality Management System, management responsibility,
resource management, product realization, measurement
and analysis and continual improvement. However, some
terminology had been changed to harmonize the full
concept and terms in medical laboratory community. For
example, “product realization?would be a difficult
concept to be use in medical laboratories community
where “product?is the results of the medical test.
Hence the new terminology now was able to develop the
standards to be satisfied the ISO/IEC Directives that
endorse by the philosophy of ISO 9001:2000.
ISO 15189 Vs ISO 17025
ISO 15189 is: -
- Focused on the patient outcome without downgrading the
need for accuracy of measurements;
- Emphasizes not only the quality of the measurement but
of the total service of a medical laboratory
(consultation, turn around time, cost effective etc);
- Uses a language and terms that are familiar in the
- Highlights important features of pre and post
investigational issues; and
- Addresses ethics and information needs of the medical
Effective Records Management Program in ISO 15189
The new ISO 15189, Information and Documentation &
Records Management clearly shows how any organization
can systematically and effectively improve their record
keeping in such a way that the business objectives are
- ISO 15189 identifies the key issues involved in
retaining the information and making it available in a
useable and reliable way as well as how it may be
selectively and securely disposed at the appropriate
- The standard enables organizations to develop policies,
strategies and programs which will ensure that
information assets have the essential characteristics of
accuracy, integrity and reliability. Information thus
presented to knowledge workers will be of the highest
quality, currency and useful.
- IT managers will be able to use the standard to identify
features and functionality that systems must have in
order to meet the organization’s information needs,
including regulatory and audit constraints.