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    Medical devices

    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.
    ISO 15189 is a globally used standard that contains qualification and quality requirements for medical laboratories. The standard is used to ensure, among other things, that medical laboratories meet the requirements of the authorities and customers at different stages of the processes.

    Internal auditing is used as a tool for the development of the quality system, and it is also one of the requirements of the standard. In the training, 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.

    Topics

    Training Day 1
    • Introductions and training objectives
    • Basic concepts and procedures of quality and auditing
    • ISO standard concepts and documentation requirements
    • Internal audit process and requirements
    • Planning, executing, and reporting internal audits
    • Review of example cases
    • Instructions for the intermediate assignment (audit exercise)

    Training Day 2
    • Review of intermediate assignments
    • Observations, nonconformities, and evidence in internal audits
    • Defining corrective actions and verifying effectiveness
    • Internal audit and quality management tools

    Target group

    Professionals working with quality processes in a clinical laboratory and those responsible for quality management and internal audits. It is also suitable for anyone interested in quality work and the SFS-EN ISO 15189:2022 standard.

    Objectives

    • Basic understanding of the concept, objects and procedures of auditing. 
    • Understanding of the importance and benefits of auditing as a tool for evaluating and developing a quality management system.
    • Able to act as an internal auditor of a quality management system that meets the requirements of the ISO 15189 standard.

    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

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