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    Medical devices

    Introduction to ISO 15189:2022

    This training provides an overview of the ISO 15189:2022 standard and its requirements.

    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

    • 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

    Trainers

    Ullastiina Hakala
    Ullastiina Hakala
    Quality and Regulatory Expert
    Ullastiina is an experienced quality professional with strong organic and analytical chemistry background, and deep understanding in IVD Medical Device Assays, Laboratory Management, Scientific Research and Training. She also has specific experience in IVDR and in-house IVD products.

    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.

    Objectives

    • 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

    Additional information

    The course is held online. Course material is in English, with verbal presentation and discussions in English or Finnish depending on the participants.

    Cancellations must always be communicated to academy@aurevia.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 2-4 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended. Aurevia reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course. Aurevia reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.

    Related courses

    ISO 15189 standard internal auditing
    In this two-day course, you will gain basic knowledge of the concept, objects and procedures of auditing, as well as the skills to act as an internal auditor in your own organization in context of the ISO 15189 standard.