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Quality Management Updates

Understanding ISO 13485:2003 - AIAG Training

AIAG Training Services

Understanding ISO 13485:2003

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  • In this two-day course, learn the concepts of ISO 13485:2003 and obtain invaluable insight into the benefits the process approach of ISO 13485 can deliver to your business management system. You will engage in activities that create an understanding of each standard element and the benefits of each element for your organization and for you as a participant in a business management system. Additionally, you will create a basic business model for elements of the standard, with inputs, transformations, and outputs.

    NOTE: Attendance to the entire course is required to receive a Certificate of Attendance with CEUs.
     

    CEU credit: 1.50

  • Dates Location Course Time Member List Status Seats Available Language

    On Demand*  

    Southfield, MI USA  

    8:00 AM - 5:00 PM  

    Contact: trainingcontact@aiag.org for registration and pricing information.  

    25

    English  

    * Courses are scheduled based on demand. If you are interested in attending this course, please provide us with your information and
      we will contact you when a course date is scheduled.

  • Who Should Attend

    Recommended for anyone who wants/needs to learn about ISO 13485, trainers who want a simple, effective method of explaining ISO 13485 to employees, potential internal auditors, and risk and quality managers.

    Course Outline

    • Apply invaluable insights into the benefits the process approach of ISO 13485:2003 can deliver to any business management system.
    • Assimilate purpose and intent of the ISO 13485 standard
    • Define the process approach and how it impacts the use of ISO 13485:2003.
    • Identify and understand the process within your organization.
    • Apply the 8 quality management principles upon which the ISO 9000 family of standards were based.
    • Define Terminology and exclusion requirements in ISO 13485:2003
    • Apply the standard's clauses and relate the intent of the standard
    • Create a basic business model for elements of the standard - with inputs, transformations, and outputs as any business would have.
    • Use "Reflect and Connect" exercises and compare the model to your organization's model - and confirm insights gained into the process.
    • Relate key elements of the standard to your own company. Clause-by-clause review of the standard ensures understanding - and each clause is applied to your own company.

  • Related Courses

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For onsite training information and a price quote please call (248) 358-3570.

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Via Email: trainingcontact@aiag.org
Customer Service: (248) 358-3003 | Fax: (248) 358-3570

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