To address the requirements of Medical Device Directives, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. Learn to apply your knowledge to the development of an ISO 13485:2016 compliant QMS and maintain the on-going certification of your organization.

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.

This course teaches the principles and practices of effective quality management system audits against ISO 13485, in accordance with ISO 19011, “Guidelines for auditing management systems” and ISO 17021, as applicable. Experienced BSI tutors will guide delegates through the entire audit process, from initiating the audit through to conducting audit follow-up.