A strong understanding of ISO 13485 is an essential requirement for anyone with responsibility for the manufacture, processing and reprocessing of medical devices. Getting to grips with this international standard is key to ensuring that a Sterile Services Department operates safely and effectively. In this course, you will unpack ISO 13485 with a simple, intuitive guide that explains the core concepts behind the standard and lays out the requirements for compliance. As a learner, you will achieve the following objectives:
- Understand how ISO 13485 fits into the wider picture of compliance in the UK
- Learn the building blocks of a Quality Management System and how its various elements interact
- Break down the clauses of ISO 13485 and understand their application to your setting
- Learn your responsibilities and those of others around you in terms of ISO 13485 compliance.
Broken up into multiple sections, this course enables you to learn at your own pace, revisiting key topics and referring back to guidance as often you as wish. Each section culminates in a short quiz. These quiz results combine to help you achieve certification without the need for a single, long assessment.
Ideal for SSD leads, internal auditors and anyone with an interest in quality management. Course duration: 2 hours (approximate)
