Quality Management Systems – ISO 13485:2003

This introductory course covers the basic requirements of ISO 13485 and its implications within a medical device manufacturing company.

As the ISO Standard 13485-2003 Medical Devices states;

“All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.”

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Understand the definition of a Medical device and what ‘intended use’ actually means for 13485 compliance
  • Understand the intent and scope of the 13485 standard
  • Have a practical, working knowledge of the 13485 and people’s responsibilities in maintaining compliance with this Standard
  • Know how to practically implement the fundamentals of 13485
  • Realize the importance of 13485 compliance
  • Understand the processes that drive the 13485 Standards
  • Implement documentation regulations for procedures, work instructions and records
  • Course materials

    Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

    A certificate of completion will be issued to participants who successfully complete the assessment.

    Assessment

    A written assessment is conducted at the end of the course.

    Course Format

    The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

    Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations or Manufacturing personnel