ISO 13485 Basic Training

ISO 13485 Basic Training has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Anyone involved with the implementation of the standard

What will I learn?

On completion of this training, participants will be able to:

  • Compare the requirements between ISO 13485 and ISO 9001
  • Interpret the clauses of ISO 13485
  • Recognize the role and responsibilities of management in ISO 13485
  • Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide.
  • Understand the implementation of a Quality Management System in accordance with ISO 13485
  • Understand the relationship between a Quality Management System and compliance with customer and regulatory requirements
  • Know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Quality Management System as specified in ISO 13485
  • Acquire the necessary knowledge to contribute in implementing a Quality Management System as specified in ISO 13485

How will I benefit?

  • Take the first steps towards ISO 13485 certification
  • Understand how you can better meet customer and regulatory requirements
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices
  • Motivate employees.

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