ISO 13485:2016 Standard Training

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.

Every member of your workforce who participates in planning, leading, and conducting your company‚Äôs QMS audit activities and managing its environmental program will benefit from taking ISO 13485:2016 training. Estimated to take up to 10-hours to complete, this online, on-demand ISO 13485 course is particularly adapted for training all levels of the organization on all the requirements of this standard.

What Will You Learn

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

Course Information

COURSE LENGTH
10.00 Hours
ACCESS PERIOD
365 Days

Is This Course For You

This course is for you if you want to:
  • Quickly and efficiently get a comprehensive training on ISO 13485:2016
  • Improve your curriculum vitae and career opportunities with qualifications in ISO 13485:2016
  • Upgrade your expertise from internally auditing with ISO 13485:2003 to ISO 13485:2016
  • Train staff on all of the requirements and areas of ISO 13485:2016

Find answers to FAQs.

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

Course Requirements

  • Windows 7, 8, 10 (other operating systems and mobile platforms are not supported but may work)
  • Internet Explorer 11, Mozilla Firefox 37, Google Chrome 42 (other browsers are not supported but may work)
  • Broadband-1Mbps minimum

Topics

  • Introduction
  • Risk-based thinking
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement

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