ISO 13485 Requirements from A to Z

This course helps you understand ISO 13485 requirements. You’ll apply and interpret ISO 13485 clause-by-clause and know what’s different about this standard from ISO 9001. The course is especially designed for auditors, supervisors, and managers in the medical device industry.

Self-Paced
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Web-Based
List: $389.00
Member: $349.00
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Learn about ISO 13485 and ISO 9001 requirements, interpret the ISO 13485 standard, and apply these requirements to your work would by completing a series of lessons, illustrations, diagrams, interactive exercises and quizzes.

  • Learning Objectives
    • Describe how the ISO 9000 family of documents was developed.
    • Interpret ISO 9001 and ISO 13485 requirements clause-by-clause.
    • Describe the conformity assessment process.
    • Analyze the quality management systems for nonconformities.
    • Explain quality management system terminology.
  • Who Should Attend

    Auditors, supervisors and managers in the medical device industry

  • More Information

    Prerequisites

    Medical device industry experience is helpful.

    Materials:
    A handy Desk Reference (student textbook), QualityWBT Glossary, and other resources
    More than 20 downloadable handouts such as: an ISO 13485 checklist, study tips, a before-class assessment, and after-class objective.
    Online access to ISO 9000 (vocabulary standard) granted with the purchase of this course.
    Certificate of Completion

    Course Data

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