ISO 13485 Training 01 (DQMS01)
This introductory one day course covers the basic requirements of ISO 13485 and the implications thereof to staff working in medical device manufacturing companies.
For example;
- Operations / Manufacturing personnel
- Quality Assurance personnel
- Quality Control personnel
As the Australian Standard ISO 13485-2003 Medical Devices states; “All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.” – 1.2 Application
Learning Objectives and Course Description
This course includes:
- understand the definition of a Medical device
- understand the intent and scope of the ISO13485-2003
- a practical, working knowledge of the ISO13485-2003 and people’s responsibilities in maintaining compliance with this Standard
- how to practically implement the fundamentals of the ISO13485-2003
- realise the importance of ISO13485-2003 compliance
- understand the processes that drive the ISO 13485-2003 Standards
- documentation regulations that apply to procedures, work instructions and records
- medical device Classifications, and what intended use actually means for ISO13485-2003 compliance
- understand the intent and scope of the AS ISO13485-2003
- have a practical, working knowledge of the AS ISO13485-2003 and their roles in maintaining compliance with this Standard
- know how to practically implement the fundamentals of the AS ISO13485-2003
- realise the importance of AS ISO13485-2003 compliance
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
Benefits include
- learning from experienced professional trainers
- understanding ISO 13485 and its applications for shop floor personnel
- one on one tuition during the course as the classes and are small and intimate
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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