To address the on-going concerns of Medical Device Directives and Regulations in Australia, organizations must demonstrate their commitment to the safety and quality of their products. An ineffective audit can mean severe consequences, resulting in process failure, customer dissatisfaction and regulatory non-compliance.
This course enables a clause-by-clause understanding of ISO 13485, which outlines the comprehensive requirements of an effective QMS. Develop your understanding of Australian Quality Systems Regulations and what to consider when auditing in conjunction with ISO 13485.
How will I benefit?
This course will help you:
- Prepare, conduct and follow-up on ISO 13485 compliant QMS audit activities
- Gain the skills to assess an organization’s capability to manage its Quality Management System
- Offer confidence to customers and suppliers that a device meets regulatory requirements
- Write factual audit reports and suggest corrective actions
- Enhance customer satisfaction though effective audit application and commitment to continual improvement
Who should attend?
- Quality Managers
- Internal Auditors
- Regulatory Affairs Managers
Note: Existing knowledge of the Australian Quality System Regulations is a pre-requisite for this course.
What will I learn?
You will learn about:
- Australian Therapeutic Goods (Medical Devices) Regulation requirements
- What to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485
What's included?
- Training course notes
- Lunch
