ISO 13485 – Medical Devices courses

ISO 19011:2026 provides the current guidelines for auditing management systems and serves as the foundation for conducting professional internal and supplier audits (1st- and 2nd-party audits).In this three-day auditor training course, you will gain the practical knowledge and competencies required to systematically plan, conduct, and follow up on audits. You will learn how to use audits effectively as a tool to evaluate the effectiveness of management systems, identify opportunities for improvement, and support the continuous development of your organization.A strong emphasis is placed on practical application. Through hands-on exercises, case studies, and audit simulations, you will build confidence in handling real-world audit situations—from preparation and execution to the evaluation and follow-up of audit results.The course content is designed to be applicable across management system standards and can be transferred to all management systems based on the High Level Structure (HLS), including ISO 9001 and ISO 14001.

This training introduces you to management responsibilities under ISO Management System Standards.COURSE CONTENTOverview of ISO Standards, Annex SL standardization, and the PDCA process for continual improvement.Key management responsibilities in Clause 5 (Leadership) and Clause 9 (Performance Evaluation).COURSE CERTIFICATION:On completion of this course:The SGS certificate is available to download once you have achieved a pass mark of 80% or more in the final assessment which completes this course.You have 12 months access to this course, effective from the date of purchase.

This eLearning course aims to familiarise you with the auditing management systems guidelines in accordance with ISO 19011:2018.

This course will provide participants with an overview of the critical changes in relation to EU In Vitro Diagnostic Regulation, along with the implementation timescales.