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    Introduction to ISO 15189:2022

    To support quality management in medical laboratories, it is possible to adopt the ISO 15189:2022 standard, which is based on the requirements of the ISO 9001:2015 standard. ISO 15189 outlines the requirements for the operation of medical laboratories. Alongside management requirements, the standard places particular emphasis on technical requirements across various stages of the laboratory process, as well as the management of risks related to operations.

    Topics of this session

    • Benefits of a Quality Management System in developing and evaluating operations
    • Structure and content of the SFS-EN ISO 15189 standard
    • Terms and definitions in the SFS-EN ISO 15189 standard
    • Quality requirements and characteristics in healthcare from the perspective of ISO 15189
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    Trainers

    Nina Vartiainen
    Nina Vartiainen
    Senior Specialist
    nina.vartiainen@aurevia.com

    Nina Vartiainen is a biochemist with a PhD in molecular neurobiology. She has over a decade of experience in multinational teamwork and project management in R&D projects. Most recently, she has worked with medical device and laboratory quality management systems. She also has hands-on experience in business development by integrating product development projects with quality and regulatory frameworks.

    Nina Vartiainen on molekulaarisesta neurobiologiasta väitellyt biokemisti. Hänellä on yli vuosikymmenen kokemus monikansallisesta tiimiyhteistyöstä ja projektinhallinnasta T&K-projekteissa. Viimeisen 10 vuoden ajan hän on työskennellyt lääkinnällisten laitteiden ja laboratorioiden laadunhallintajärjestelmien parissa, ja hänellä on omakohtaista kokemusta liiketoiminnan kehittämisestä yhdistämällä tuotekehitysprojekteja laatu- ja sääntelykehykseen.

    Target group

    This training is intended for individuals working with quality processes in their organization and those responsible for quality management. It is also suitable for anyone interested in quality work and the SFS-EN ISO 15189:2022 standard.

    After this session, you

    • Understand the benefits of a quality management system in developing and evaluating operations
    • Interpret the requirements of the SFS-EN ISO 15189:2022 standard
    • Identify and describe the key processes in your own operating environment

    What next?

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    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here. Participation in the other trainings can be cancelled two weeks (14 days) before the event free of charge.

    Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

    Cancellations are always made in writing to: info@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  info@aurevia.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Aurevia reserves the right to cancel the training session due to a small number of participants.