www.isocertificationtrainingcourse.org registrar@isocertificationtrainingcourse.org
ISO 13485 Awareness Training ISO 13485 Awareness Training Course Features ISO 13485 Awareness Training gives delegates a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485 requirements. ISO 13485 Awareness Training includes exercises to provide delegates with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process. What you will learn in ISO 13485 Awareness Training Overview of the ISO 13485 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.