ISO 13485 Medical Devices Internal Auditor Training BSI Singapore
Price: 900 SGD

    Course details

    Who should attend?

    Medical device quality professionals with knowledge of quality management systems and ISO 13485
    Individuals interested in conducting first-party or second-party audits
    Management representatives
    Internal auditors
    Managers
    Consultants
    This course does not detail the requirements of ISO 13485:2003 so some previous knowledge is required
    "Very good to learn more on ISO 13485 clauses and internal auditor roles & responsibilities. Thanks for the course." Mohankumar, Becton Dickinson Medical Products Pte Ltd
    What will I learn?

    On completion of this training, participants will be able to:
    Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
    Identify the principles of auditing and auditor responsibilities
    Plan an internal audit
    Conduct informal opening and closing meetings
    Conduct an audit based on process identification, sampling and questioning
    Provide verbal and written feedback
    Document concise nonconformities
    Effectively report on an audit
    Follow-up on corrective actions
    What are the benefits?

    Be better able to continue compliance with ISO 13485
    Maintain and improve a global benchmark in quality standards
    Be confident that your organization can rely on ISO certified internal auditors
    Motivate colleagues through CPD and build customer confidence.
    What is included?

    Training course notes
    Lunch
    Refreshmensts
    Pen

    Updated on 08 November, 2015

    About BSI Singapore

    BSI is the business standards company that helps organisations all over the world make excellence a habit. For more than a century BSI have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organisations improve, BSI's clients range from high profile brands to small, local companies in 150 countries worldwide. See all BSI Singapore courses
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