This training course will prepare you for designing and controlling a QMS for the medical device industry in accordance with the ISO 13485 standard, and for auditing a quality management system as per ISO 13485. On completing the training, you will be able to:
- design and control a QMS for the medical device industry in accordance with the ISO 13485 standard,
- audit quality management systems in accordance with ISO 13485.
Who is concerned?
There are no prerequisites for this training course.
Defining the scope of the quality management system
Understanding the context of ISO 13485 and the regulations
Familiarization with the ISO 13485 standard specific to medical devices
Understanding and analyzing the ISO 13485 standard
Implementing the quality system in accordance with the ISO 13485 standard
Acquiring the quality audit methodology in accordance with the ISO 13485 standard
Audit methodology applied to medical devices
Monitoring and measuring the system and process performances
Putting improvements in place
• Improvement tools
• Enhancing customer satisfaction
Using the vocabulary judiciously
• Vocabulary associated with each stage of the training
Understanding the stages in the certification project
• Coordination of the certification project
• Positioning certification amongst the company’s issues
We are committed to support you in the success of your training.
40 years of experience in trainings
12 training centers worldwide
A large range of e-learning training courses
10 000 students per year
Certified training courses (ICA, IRCA, …)
40 offices worldwide
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