Medical Laboratory System and Internal Audit as per ISO 15189: 2022


About ISO 15189:2022

ISO 15189:2022 is an international standard that specifies requirements for quality and competence in medical laboratories. It outlines criteria for the management of quality, personnel, equipment, and the examination process itself, ensuring accurate and reliable results. This standard is designed to help medical laboratories consistently produce valid results, promote confidence in their services, and facilitate the exchange of information among laboratories and other stakeholders.

Compliance with ISO 15189:2022 demonstrates a laboratory's commitment to quality and competence in medical testing, ultimately contributing to improved patient care and safety.

 

Training Shall Broadly Cover

  • A structured and comprehensive interpretation of the requirements of ISO 15189:2022 for implementation in the Medical Laboratory
  • Exercises/Workshops with real-life scenarios and case studies to make the training session interactive and more engaging
  • The course includes planning, managing, conducting, and leading the internal audits of the Medical Laboratory
  • There will be an exclusive session on Internal Audit and Management Review in the Medical Laboratory
  • The requirements of accreditation of a Medical Laboratory by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the International Dimension of Accreditation shall also be covered etc.
  • Dedicated ‘Question and Answer’ sessions to facilitate and provide participants with the opportunity to engage actively, seek clarification, and deepen their understanding through interactive dialogue

 

Prerequisites

There are no formal prerequisites for attending the training ‘Medical Laboratory System and Internal Audit as per ISO 15189: 2022’. However, it is preferred if the participant has a fair knowledge of Medical Laboratory and Accreditation.

 

Who Should Attend?

  • Medical Professionals involved in medical testing and point-of-care testing
  • Owners/Management Personnel of Medical Laboratories
  • Consultants
  • Quality Professional
  • Assessors
  • Regulators, Internal Auditors, etc.

 

What’s Included?

  • Learning materials
  • Copy of ISO 15189:2022 (For Training Purposes only)
  • Certificate of participation (Certificate shall be issued as a ‘Soft Copy’ from our Training Portal. This certificate can be verified anytime from our website tcb.qcin.org by entering its unique ID number or scanning the QR Code)

 

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