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    Medical devices

    ISO 13485 Standard Internal Auditing

    In this two-day course, you will gain fundamental knowledge of the concept of auditing, its scope, and procedures, as well as the skills and qualifications to function as an internal auditor in accordance with the ISO 13485:2016 standard within your own organization.

    ISO 13485:2016 is a globally recognized management system standard for manufacturers of healthcare devices and supplies, as well as other operators in the field. The standard ensures that the regulatory and customer requirements for healthcare devices and supplies are fulfilled at every stage of a product’s lifecycle. Internal auditing is utilized as a tool for developing the quality system, and it is also one of the requirements of the ISO 13485 standard.

    In this training, you will gain fundamental knowledge of the concept of auditing, its scope, and procedures, as well as the skills and qualifications to function as an internal auditor in accordance with the ISO 13485:2016 standard within your own organization. The auditing process is based on the ISO 19011 auditing standard for management systems. The training also addresses the additional requirements placed on the quality system by EU legislation (MDR 2017/745, IVDR 2017/746). The training is conducted in two parts. The intermediate assignment involves conducting an audit exercise in your own organization. Basic knowledge of the ISO 13485:2016 standard is required to participate in the training. The training includes small-group discussions and interactive exercises using various tools.

    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
    • Special characteristics of auditing subcontractors
    • EU legislation (MDR 2017/745 and IVDR 2017/746) requirements for the quality management system
    • Review of example cases
    • Internal audit and quality management tools

     

    Trainers

    Leena Raunio
    Leena Raunio
    Quality and Regulatory Affairs Manager
    Leena Raunio is a medical device professional with over 20 years of experience within the industry. She has held senior managerial positions in quality and regulatory management and has hands-on experience in building, running, and auditing quality management systems (ISO 13485, MDR, FDA QSR). She is a certified ISO 13485 and MDSAP lead auditor. 

    Target group

    Professionals working with healthcare devices and supplies; quality managers; those responsible for developing and maintaining the quality management system or interested in these topics. Basic knowledge of the ISO 13485:2016 standard is required to participate.

    Objectives

    • Gain a fundamental knowledge of the concept, scope, and procedures of auditing
    • Understand the significance of auditing as a tool for developing quality management
    • Gain the skills to function as an internal auditor in compliance with ISO 13485:2016 requirements
    • Understand how to incorporate additional quality system requirements imposed by EU legislation (MDR 2017/745, IVDR 2017/746) into internal audits
    • Understand the special characteristics of auditing subcontractors

    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 13485
    This training provides an overview of the ISO 13485:2016 quality management system standard and its requirements. The training includes small-group discussions and interactive exercises using various tools.