Course Description
BSI’s “Implementing ISO 13485:2003” two day course has been designed to provide participants with the knowledge and process steps to enable them to effectively Implement a quality management system in line with the requirements for ISO 13485:2003 certification.
The course introduces the concepts needed to understand, develop, and implement a quality management system.
Learning Objectives
On completion of the training, participants will be able to:
- Explain the structure and scope of the ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
- Describe the implementation process
- Produce a project plan for implementation
- Identify and justify the resources required for implementation
- Facilitate development of processes, policies, objectives, documentation and measurement techniques
- Prepare for ISO 13485 certification
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
Prerequisites
Designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001:2008, or ISO 13485:2003 would be beneficial.
Further Information
Fee: Two-day course including refreshments, lunch and course notes £1070 + VAT.
Attendance on this course will provide delegates with 16 CPD points.
