ISO 13485 Awareness Training
ISO 13485 Awareness training course will fulfill your need to know and learn about ISO 13485 standard and the medical devices quality management system. This training course is designed to help participants know what exactly is ISO 13485 standard, where it is applicable and what are the principles on which this standard is based. It helps to understand the relationship between ISO 13485 and ISO 9001 quality management system standards. The course will also help you know ISO 13485 quality management system requirements and the steps need to be taken by medical device companies for ISO 13485 certification. Additionally this course will be helpful to understand the meaning of documented information, the documents and records requirements of ISO 13485 standard and the key points to consider for control of quality management system documented information. All these things will be briefly but effectively covered in the ISO 13485 awareness training course. The training will provide a genuine knowledge of ISO 13485 documented information, certification process steps and ISO 13485 Medical Device Quality Management System requirements. This training will equip you with in-depth knowledge that can be immediately applied to thrive in today’s competitive medical device industry.
What you’ll learn
- Features, applicability and key elements of ISO 13485 standard, including the high-level structure and framework of the ISO 13485 standard..
- The benefits of implementing ISO 13485:2016..
- The quality management principles of ISO 13485 standard..
- The requirements of ISO 13485:2016 standard for system compliance and certification..
- Documentation structure for effective system implementation and ISO 13485 certification..
- The essential steps involved in obtaining ISO 13485 certification for your organization..
Course Content
- Introduction –> 2 lectures • 32min.
- Overview ISO 13485:2016 Requirements –> 1 lecture • 18min.
- Control of Documents and Records for ISO 13485 –> 3 lectures • 46min.
- Steps for ISO 13485:2016 QMS Installation & Certification –> 2 lectures • 34min.
- Final Exam –> 0 lectures • 0min.
Requirements
ISO 13485 Awareness training course will fulfill your need to know and learn about ISO 13485 standard and the medical devices quality management system. This training course is designed to help participants know what exactly is ISO 13485 standard, where it is applicable and what are the principles on which this standard is based. It helps to understand the relationship between ISO 13485 and ISO 9001 quality management system standards. The course will also help you know ISO 13485 quality management system requirements and the steps need to be taken by medical device companies for ISO 13485 certification. Additionally this course will be helpful to understand the meaning of documented information, the documents and records requirements of ISO 13485 standard and the key points to consider for control of quality management system documented information. All these things will be briefly but effectively covered in the ISO 13485 awareness training course. The training will provide a genuine knowledge of ISO 13485 documented information, certification process steps and ISO 13485 Medical Device Quality Management System requirements. This training will equip you with in-depth knowledge that can be immediately applied to thrive in today’s competitive medical device industry.
The ISO 13485 training program includes the following key elements:
- Overview of ISO 13485:2016 Medical Devices Quality Management System
- ISO 13485:2016 Requirements
- Control of Documents and Records
- Steps for ISO 13485:2016 QMS Installation & Certification.