Full program description
ISO 13485: 2016 Awareness Training
What's In It For Me
This course is specially designed to equip participants with a comprehensive understanding on the requirements and implementation phases of the ISO 13485: 2016 quality management system for medical devices.
To express your interest for enrolment in this course, please fill up this form at www.surveymonkey.com/r/WSHdemandform. We will contact you when the class schedule is released. Thank you!
ISO 13485:2016 specifies requirements for a quality management system where organisations need to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device; and design and development or provision of associated activities (e.g. technical support).
ISO 13485:2016 can also be used by suppliers or external parties that provide a product, including quality management system-related services to such organisations.
Who Should Attend
- Introduction to ISO 9001: 2015 & ISO 13485: 2016
- Relation between ISO 9001: 2015 to ISO 13485: 2016
- ISO 13485: 2016 requirements
- Cross reference to ISO 14971: 2007 (Application of risk management to medical devices)
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realisation
- Measurement, analysis and improvement
Certification Obtained and Conferred by
Certificate of Participation from NTUC Learninghub
Note: Due date for all companies to transit to ISO 13485 : 2016 is February 2019.