ISO 13485 Awareness Training

ISO 13485 Awareness Training provides you with an overview of the purpose and requirements of ISO 13485 and how to improve customer relationships, operations and corporate culture by the effective use of a QMS.

The training is an introduction for anyone involved in the development, implementation and management of a QMS based on ISO 13485. Upon completing the training, you will be able to interpret all clauses of ISO 13485:2003 and recognize the role of management in implementing and maintaining ISO 13485.
If you plan to complete other QMS training, such as internal auditing and the Lead Auditor Training, you will receive during this course the knowledge and understanding of ISO 13485 upon which to build auditing skills.

The course comprises lecture and workshop exercises.

What your team will learn in this intensive ISO 13485 training class:

  • Overview of the ISO13485:2003 standard and the implications to your company.
  • The responsibility of senior management.
  • Why the process approach makes sense.
  • Setting objectives and defining responsibilities.
  • Benefits of adopting the standard and regulatory requirements.
  • Who needs to be involved within the company.
  • Creating the quality policy manual.
  • Role of design and development, purchasing, production, record keeping, customer communications.
  • Continuous improvement, how and why.
  • Process validation, monitoring and traceability, control of measurement devices and data analysis.