Overview
The ISO 13485:2016 standard specifies requirements for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Such medical device 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 such as technical support.
ISO 13485:2016 can also be used by suppliers or external parties that provide products, including QMS-related services to such organisations.
This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved.
Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.
This course will be useful as a refresher or for those new to the medical device industry.
CPD Hours: 6
Course Content
- Day 1
- Overview of ISO 13485:2016
- Defining the Scope and Objectives of Your QMS
- Documentation Requirements
- Workshop Exercise: Writing Quality Policy and Objectives
- Intellectual Property (IP) to CE Marking in a QMS
- Supplier Management
- Direct Processes
- Post Market Surveillance
- Workshop Exercise: Quality Management - Functional Interaction
- Summary and Key Take Aways
