ISO 13485 Training
Quality Management Systems provide the organizational structure for the policies, procedures, processes and resources required to manage the quality of your product/service and meet customer requirements.
ISO 13485 is the the world’s most established and utilized standard for medical device quality management. The BRC’s full suite of courses covers understanding requirements, implementing them within the organization, and conducting internal audits of an ISO 13485 quality management system.
Understanding & Implementing ISO 13485:2016
This 2 day course delivers a solid understanding of the ISO 13485:2016 requirements and practical guidance on tools and approaches to implement an ISO 13485 quality management system within an organization.
Learn the standard through immersive, hands-on exercises and discussion, and review approaches and techniques for implementing the key concepts.
ISO 13485:2016 Internal Auditor
A review of the ISO 13485:2016 standard, followed by in-depth instruction on the skills and techniques required to participate as a member of an auditing team.
Course combines presentations and case studies with individual and group exercises to teach the skills required to perform internal quality audits, and adheres to ISO 19011:2018 auditing guidelines with an emphasis on the Process Approach to auditing.
ISO 13485:2016 Management Overview
A high-level overview of the ISO 13485:2016 standard, key concepts relating to management activities, and the ways in which an ISO 13485:2016 quality management system is aligned and integrated with the organization’s strategic goals and objectives.
Ideal for those who do not need a detailed understanding of the specific requirements, but who will be involved in high-level, strategic decision making and leadership roles.
