ISO 15189:2012

Gain International compliance for Medical Laboratory competence and quality with ISO 15189

Medical Test

ISO 15189:2012 Medical Laboratories

ISO 15189:2012 is an International Standard for medical laboratories. Its criteria help labs develop quality management systems and appraise their competence.

An accredited laboratory is required to have a quality management system that consists of a quality manual, explaining how the laboratory will conform to each requirement of the ISO15189:2012 International Standard. A collection of quality procedures that provide instructions for performing the tasks must be carried out to conform to the standards’ requirements.

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Why ISO 15189?

Laboratory testing is playing an increasingly important role in the delivery of information-based healthcare outcomes. As the ultimate recipients of such testing are patients whose systems are compromised by disease, it is critical that such testing is only carried out by competent personnel and those who work to the highest ethical standards. The results delivered by such testing must be both clinically relevant and conform to the highest quality standards.

Achieving accreditation to the ISO15189:2012 International Standard demonstrates a laboratory’s commitment to delivering results that meet internationally recognised standards for quality and competence. Achieving this accreditation is a significant undertaking. It will often require skills not routinely used by the laboratory, and it may not be economical to retain such expertise on the permanent staff.

IMSM can provide consultancy services to assist you in implementing the ISO15189: 2012 International Standard; for further information, please click below.

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ISO 15189 Business Benefits

  • Reduction in risk by using well structured best practices.
  • Recognises and promotes the technical competence of staff.
  • Assures client results are technically valid and saves costs associated with retesting.
  • Conveys trust and a level of recognition to stakeholders and decision-makers.
  • Improves staff motivation and reduces staff mistakes.
  • Ensures support in the event of a legal challenge.
  • Assists in the development of additional programmes.
  • Assures that clinical laboratory services are safe, reliable, and of good value.
  • Provides a tool for measuring quality improvements and supporting consistency.

One of the main benefits of ISO 15189 accreditation is that it is globally recognised. A series of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the world.

Committed to Quality

Achieving accreditation to an International Standard demonstrates that your laboratory is serious about delivering quality systems through externally accredited processes. Internally International Standards provide focus and discipline, and externally you will achieve credibility, authority, and recognition.

Increase confidence in your proficiency; call IMSM now for an informal discussion on how your medical laboratory can become ISO 15189 accredited.


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