ISO 15189 – Quality Management in Medical Laboratories

ISO 15189 is a global initiative that aims at creating a standard measure of quality in medical laboratories. The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipments and outcomes. ISO 15189 was developed by the International Standards Organizations Technical Committee and has been implemented in over 200 countries. The process involves testing of the effectiveness of laboratory equipments and the impact those particular equipment have on the processes in the labs and their outcomes.

It is an initiative that presents a global concerted approach in creating a standardized measure for management practices in medical laboratories. An ISO 15189 certification has been seen as a critical initiative towards harmonizing global practices in medical laboratories towards a common measure of quality assurance and safety. The approach takes into account a lot of perspectives, including the interpretation of test results, the method patient samples are actually collected as well as the time required for the tests to be carried out.

The following are the basic requirements for ISO 15189 certification:

  • A well documented procedure analysis by the laboratories.
  • Training manual provided by the laboratories.
  • ISO 15189 requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
  • Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
  • A detail audit of management reviews

The ISO 15189 certification has a set of very unique benefits and the main objective of certification is quality assurance.

The benefits are listed here below:

  • An ISO 15189 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
  • Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
  • Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
  • The certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
  • Ultimately promoted the growth of customer satisfaction in organizations involved in medical laboratory testing

Our approach

QSE’s “Ten Step Approach” to Registration is designed and perfected to cost- effectively prepare facilities for successfully passing Certification Audits with minimum or no nonconformities. QSE emphasizes on developing Simplified Documented Management Systems to meet or exceeds the requirements of any ISO Standard requirements. This 10 Step Approach has a built-in discipline to involve all employees including top management right from the beginning to achieve long-term desired results. Our approach is so complete that we have helped over 600 companies obtain certification, of which, majority have obtained certification with zero deficiencies. Please contact us for details…….