ISO 13485 Requirements from A to Z 20[M] Ed.

Group: Standards
Length: 180 days
CEUs*: 2
Tuition: $429.00
*CEU = Continuing Education Unit

This class is for auditors, supervisors and managers in the medical device industry who want to 1) learn about ISO 13485 and ISO 9001 requirements, 2) interpret the standard, and 3) apply requirements to their work situation. The class is based on a portion of an Exemplar Global approved ISO 13485 Certified Lead Auditor class. This class provides on-line access to ISO 9000 (vocabulary standard) and over 20 downloadable handouts such as: an ISO 13485 checklist, a Student Textbook, Study Tips, a before-class assessment and after-class objectives, and so on. Students must apply what they learned by completion of an assignment for marking by an instructor, and successfully passing it. If students want a copy of the ISO 13485 standard, they must provide their own, however, the standard is not a material requirement for the class. The class consists of a series of lessons, illustrations, diagrams, interactive exercises and quizzes. Successful completion of the class will result in a certificate for 20 contact hours (2.0 CEU’s). The subscription period for the class is 180 days (plus one free 30-day subscription extension, if needed).

Learning Outcomes
Students will be able to:

  • Describe how the ISO 9000 family of documents was developed
  • Interpret the ISO 13485 (ISO 9001) requirements clause-by-clause
  • Describe the conformity assessment process
  • Compare the differences between ISO 13485 and ISO 9001
  • Analyze the QMS for potential nonconformities
  • Explain QMS terminology

IACET

As an IACET Authorized Provider, JP Russell Learning Center offers CEUs for its programs that qualify under the ANSI/IACET Standard. Note: IACET is the International Association for Continuing Education & Training and CEUs are Continuing Education Units.