ISO 15189:2012 Medical laboratories — Requirements for quality and competence

What is ISO 15189:2012?

The ISO 15189:2012 is a regulatory standard for medical laboratories. Its criteria help the labs to develop quality management systems, assess their own competence, and generate technically valid results. It can also be used by laboratory clients, regulating authorities, and accreditation bodies to confirm or recognize the competence of medical laboratories.

The ISO 15189:2012 provides formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services. To maintain this recognition, laboratories are re-evaluated regularly by the certification body to ensure their continued compliance with the requirements, and to check that their standard of operation is being maintained.

The Importance of ISO 15189:2012

Many laboratories operate in isolation to their peers, and rarely, if ever, receive any independent technical evaluation as a measure of their performance. A regular assessment by a the certification body checks all the aspects of a facility’s operations related to consistently producing accurate and dependable data. Areas for improvement are identified and discussed, and a detailed report is prepared at the end of each visit. Where necessary, follow-up actions are monitored by the certification body so the facility is confident that it has taken the appropriate corrective actions.

The certified laboratories are required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence. Hereby, the ISO 15189:2012 provides a bench- mark for performance, a range of marketing advantages, and international recognition of technical competence.

The benefits of ISO 15189:2012 certification

  • Improvement in the national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • A predefined basis for all the major quality systems, related to the laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) in several different countries where test report is acceptable without repetition of analysis.
  • Customer satisfaction is achieved through the introduction of a Quality Management System which is part of the ISO 15189.

Our ISO certification service helps our clients get the certification for ISO 15189:2012 standard. To be certified on ISO 15189:2012, contact us.

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