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.
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.
"The course has been included in the list of registered public courses under the New Industrialisation and Technology Training Programme."
Each company is subject to a funding ceiling of HK$500,000 in each financial year at the course commencement date.
Please click "here" for the details of NITTP.
Who will benefit
This course will help you:
- Understand how to implement a QMS as required by medical device directives
- Plan the implementation of ISO 13485:2016 within your organization
- Take the first steps towards ISO 13485:2016 certification
- Identify how you can better meet regulatory requirements
- Find ways to increase efficiency and add value through quality management
- Monitor supply chains to achieve continuous improvement
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
On completion, you should gain the knowledge and skills to:
- Define a quality management system
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
Conduct a base line review of an organization's current position with regard to ISO 13485:2016
Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.
What is included
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
NITTP reimbursement
HK$ 1,820 ONLY (after NITTP reimbursement)
