ISO 13485 Medical Devices General Employee Training

Training Provided by Online Training Directory ISO 13485:2003 is a Quality Management System (QMS) specific to organizations providing medical devices, regardless of the type or size of the organization. This course provides a basic understanding of ISO 13485: what it is and what it requires from a company. The student has up to 1 year to access the training. However, it must be completed at one sitting, it cannot be saved and restarted later. ISO 13485 Medical Devices General Employee Training ISO 13485:2003 is a quality management system for an organization making medical devices and related services that consistently meet customer (and regulatory) requirements applicable to medical devices and related services. This standard includes unique clauses for medical devices and excludes some of the requirements of ISO 9001 that are not applicable. Therefore, conformance to ISO 9001 does not imply conformance to 13485 and vice versa. They must be independently certified. ISO 13485 is primarily concerned with "quality management". This means what the organization does to: Fulfill the customer's quality requirements Meet applicable regulatory requirements Enhance customer satisfaction Achieve continual improvement of its performance in pursuit of these objectives. After you place your order, you will receive a user name, password and log-in instructions. You will log-in and work through our interactive training for approximately 1/2 hour. The training includes slides, audio and quizzes. You will be able to work at your own pace, and will be required to pass quizzes throughout the training.

ISO 13485 Medical Devices General Employee Training Outcomes
After completion of this course the student will understand

1. What is ISO 13485
2. Why it is important to receive ISO 13485 registration
3. What employees need to do to support an implementation
4. What happens after registration

Assessment
Assessment is based upon satisfactory completion (80%) of each of the three quizzes and the final exam. Upon successful completion of the final exam, the student will be able to print a Training Certificate.
Course Outline:

• What is ISO 13485?
• Requirements of the Standard
  • General Requirements of the Standard
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement & Analysis
• Final Test

This course includes

• 8 chapters
• 3 quizzes
• final test
• Certificate of completion

Contact Hours: 2

About The Training Provider: Online Training Directory

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