ISO 13485:2016 Standard Training PD631843

Topics: Quality, Safety & Maintenance

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.  Estimated to take up to 10-hours to complete, this is a self paced course.

Objectives

By participating in this online course, you will be able to:

  • Identify the clauses within the standard
  • Summarize the high level requirements and intent of this international standard
  • Explain the process approach and its relationship to managing an organization
  • Explain how the requirements can be interpreted and implemented

 

Materials Provided

  • 365 days of online single-user access (from date of purchase) to the approximately 10 hours of instruction
  • Continuous assessment to check knowledge and application of key concepts
  • Follow-up to your content questions

For More Details

Email CustomerService@sae.org, or call 1-877-606-7323 (U.S. and Canada) or 724-776-4970 (outside US and Canada).

  • Introduction to ISO 13485
  • Risk-based thinking
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement
Access Period: 365 Days

Duration: 10 Hours
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