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ISO 15189:2022– Quality and Competence in Medical Laboratories

ISO 15189:2022 – is an International standard that addresses Quality and Competence in Medical Laboratories. ISO 15189 can be applied by any Medical laboratory in order to develop an efficient Quality Management System (QMS) and to assess its own competence.

ISO 15189:2022 is the latest standard and it was developed with the participation of the medical, scientific, and clinical community, and it contains requirements for diagnostic labs to demonstrate competence to deliver timely, accurate, and reliable results.

ISO 15189 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. 

BENEFITS OF ISO 15189:2022

    • Enables the medical laboratory to drive impressive gains in quality
    • Increases customers/patients trust for safe and competent services and therefore their satisfaction
    • Reduces the cost of mistakes and improves the financial performance of the lab in general
    • Reduces risks and encourages the sharing of best practices
    • Provides competitive advantage
    • ISO 15189 can be a part of an integrated management system (IMS), in combination with other standards such as the ISO 9001, ISO 14001, ISO 45001 etc.
ISO 15189:2022– Quality and Competence in Medical Laboratories

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Contact us for the development of your Clinical Laboratory’s Quality Management System. Our experienced and qualified consultants will help you at each stage of the process in order to get the relevant accreditation.