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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 patient testing.

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 laboratory work.

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 common standards.
  • 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 improvements.
  • 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 profession;
  • Highlights important features of pre and post investigational issues; and
  • Addresses ethics and information needs of the medical laboratory.

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 supported.

  • 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 time.
  • 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.



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