ISO 15189 Importance

Highest quality norm in laboratory research field in Europe is international certificate ISO 15189. The validity of the certificate extends to the most popular groups of services: general tests and biochemical blood tests. Now patients of certain medical institutions can not even doubt the reliability of the tests, because experts do not allow any compromise.

Development affected all stages of laboratory diagnostics, because certification in this serious mechanism is comprehensive and requires scrupulous attitude to each part of diagnostic procedure. Careful documentation preparation, which lasted more than a few years, training of employees, calibration of equipment in accredited laboratories – all this is aimed at bringing the work in line with strictest demands.

Main standard points

New standards introduction is a quick fix for transforming an inefficient company into a profitable one. The presence of certificates for companies planning to enter the European market is a mandatory requirement, since without it this process cannot be carried out.

This standard was created on ISO 9001 basis, taking into account the specifics of medicine. By implementing ISO 15189, medical laboratories receive a number of advantages, here are just the main ones:

  • improving staff work, the quality of education and scientific research of employees, and consultation results;
  • improving of services provided;
  • increase of trust level in research results;
  • competitiveness and dynamics of general development are increasing;
  • uniformity in workflow;
  • clear and transparent definition of tasks and responsibilities of staff;
  • improving the quality of customer service;
  • creation of unified communication channels in the laboratory;
  • maintaining a constant level of quality of research services;
  • clear identification of customer needs, both explicit and implicit;
  • reducing the time of adaptation of new employees to the tasks assigned to them;
  • streamlining operating costs

The document details:

  • laboratory responsibilities for work quality;
  • recommendations for development of a quality manual;
  • documentation control;
  • laboratory control of records, etc.

One of main aspects of ISO 15189 is demand for financial and ethical independence of the laboratory. Results of the analyzes carried out must be relevant and reliable in 100% of cases.

The total costs of accreditation obtaining

  • The costs of implementing includes documentation supervision, revision of contracts, subcontracting of research, procurement of services and supplies, consulting services, processing of complaints and complaints, identification and monitoring of nonconformities, preventive actions, continuous betterment, quality and technical records, and management reviews.
  • Accreditation audit.

In all cases where this is permitted by national, regional or local regulations and requests, it is desirable laboratory services provide patients checking during consultations and such services be actively used not only in patients’ treatment but also in disease preclusion. Each establishment should also provide its staff with appropriate opportunities for education and research.

 

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