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    ISO 13485 Standard Internal Auditing

    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.

    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).

    Inhalt

    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
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    Trainer

    Leena Raunio
    Leena Raunio
    Quality and Regulatory Affairs Manager
    leena.raunio@aurevia.com
    ”I’m an experienced regulatory affairs and quality assurance professional who has worked for a number of Medical Device manufacturers, ranging from biodegradable orthopaedic implants to medical software for the US, EU and many other markets. I hold experience from senior managerial roles in multinational regulatory and quality-related positions and I have supported many Medical Device manufacturers and other economic operators as a regulatory consultant throughout my career that spans two decades.”

    Zielgruppe

    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.

    Nach diesem Training

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

    Hinweis

    • 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 (e.g., Socrative, Kahoot, Mentimeter).

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