ISO 13485 Training Courses
Overview
Medical device industries need to demonstrate their ability to provide products and services that consistently meet customer and regulatory requirements. Participants in this 13485 ISO quality training course will learn the specific requirements for establishing and maintaining an effective quality management system within their organisation.
We offer traditional training delivered in-the-city or on-your-site, however pride ourselves on providing flexible customised options to meet your training needs.
We also offer eLearning or web based training GMP e-learning or GMP on-line training modules.
Traditional Classroom Training
Option 1: In-The-City training in Australia
We have a schedule of training classes in each major Australian capital city.
Why choose this training option?
These offsite training courses are ideal when you have one or two people that need training and would like them to cross pollinate ideas across businesses.
Option 2: Tailored GMP Training Courses - On site anywhere in the world
These training courses are held on your site, to groups of up to 15 people. They include assessment and electronic student handbooks. These courses can be highly customised to suit your specific requirements and can be delivered anywhere in Australia, New Zealand, and for a small extra fee to cover travelling costs in South East Asia.
Why choose this training option?
Training teams together allows them to consider real-life issues during the session and reach a common understanding. It's also a cheaper way to train more than 10 people.
The ISO 13485 Courses
Click one of the links below to get detailed information on the course / module of interest.
ISO 13485 Training 01 - DQMS01
Detailed Schedule
Click on the link below to get detailed schedule.
Who should attend
- Quality personnel
- Operations and manufacturing personnel
- Management personnel
Expected outcomes
After completing this ISO 13485 training course, participants should be able to:
- Understand the intent and scope of AS ISO 13485-2003
- Understand who enforces AS ISO 13485-2003 and it’s importance
- Understand their actions and roles in order to comply with AS ISO 13485-2003
- Know how to practically implement the fundamentals of AS ISO 13485-2003 within their organisation
Topics covered
The following topics will be covered during the course:
- Establishing and documenting a quality management system
- Maintaining and monitoring the effectiveness of a quality management system
- Controlling a quality management system, including definition of responsibilities and controlling documentation
- The importance of quality and the need to support the development of a quality management system within an organisation
- How to effectively implement a quality management system and define a quality policy
- The need to periodically review the effectiveness of a quality management system
- Identification of resource requirements and provision of quality personnel
- The need to identify and maintain a quality infrastructure and environment
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