Medical device manufacturers and sponsors need to understand and comply with the current Quality Management System (QMS) standard ISO 13485:2016.
This 2-day training course will provide you with the knowledge, skills and tools to implement a QMS in compliance with the ISO 13485:2016 standard.
At the end of this course you will be able to:
- Know your legal obligations as a sponsor or manufacturer
- Understand the success factors for an effective QMS, and the benefits it delivers
- Develop risk management strategies for products and processes
- Determine if your organisation is ISO 13485 audit-ready
- Develop plans to streamline your QMS and maintain practical compliance
The course will provide a short introduction to the regulatory landscape of Quality for medical device companies followed by practical advice to help you implement a QMS across the following four (4) key business areas of ISO 13485. It will cover:
- The Regulatory Environment
- The ISO model for an effective process-based Quality Management System (QMS)
- The application and integration of a Quality Risk Management (QRM) framework
- Key areas of ISO 13485 and changes in the 2016 standard
- Management responsibility
- Resource management
- Product realisation
- Measurement, analysis and improvement
This course will assist organisations preparing for ISO 13485 certification (or re-certification to the 2016 standard). It will also be of interest to businesses that supply to ISO 13485 regulated companies. Business types that have benefited from ISO 13485 training include:
- Medical device design and manufacturing groups
- Medical device sponsors whose products are manufactured in other regions and then distributed in Australia and Europe
- Pathology companies
- Suppliers to medical device companies looking to gain a competitive edge
Format and Course Length:
The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Contact us and register your interest in a public session or having this course delivered on-site.