Course description:

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Course Aim:

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

How will I benefit?

This course will help you:

• Plan the implementation of ISO 13485 within your organization
• Take the first steps towards ISO 13485 certification
• Understand how you can better meet customer and regulatory requirements
• Find ways to increase efficiency and adding value through quality management
• Monitor supply chains to achieve continuous improvement

What will I learn?

On completion, you should gain the knowledge and skills to:

• Define a quality management system
• Identify the steps for defining, planning, organizing and scheduling necessary activities
• Implement an effective quality management system
• Conduct a base line review of an organization's current position with regard to ISO 13485:2016 

Who should attend?

Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.

Course Duration

2 days

How will I learn?

Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

Prerequisites

You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.

Related Training

You may also be interested in attending our ISO 13485:2016 Introduction, Clause by Clause, Internal Auditor and Lead Auditor courses.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.