ISO 13485 Training 03 (DQMS03)
This advanced 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
- Technical Staff / Engineers
As the Australian Standard ISO 13485-2003 Medical Devices states;
“The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.”
Learning Objectives and Course Description
This course includes:
- understand the foundation processes of the ISO13485-2003 and implement these processes to your business units
- detailed and complete knowledge of the ISO13485-2003 and people’s roles in maintaining compliance with this Standard
- how to practically implement and manage the fundamental processes of the ISO13485-2003 to achieve and maintain compliance
- understand ISO 13485-2003 and the regulations applicable to Design and Development
- know and detail the key differences between ISO 13485-2003 and ISO9001-2000
- detail Continuous Improvement in the context of Quality Management Systems
- Quality Management Systems requirements for raw materials, third party suppliers, complaints and product recall systems
- drive Corrective Action and Preventative Action (CAPA) Systems
- understand Change Management systems and root cause analysis mechanisms
- realise the importance of associated Standards, such as ISO 14971, Risk Management for Medical Devices
- the imperative roles and responsibilities that Managers of Medical Device companies must adhere to
- “Management commitment” and how to demonstrate commitment to your company and the regulators
- 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
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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