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This intensive course is designed to provide participants with an in-depth understanding of the ISO 13485:2016 standard, focusing on the requirements for a medical device quality management system and the skills needed to lead audit teams effectively. The course combines comprehensive theoretical knowledge with practical auditing exercises, role-playing, and group discussions to ensure participants are well-equipped to conduct and lead internal and external audits.SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsAU – Auditing Management SystemsTL – Leading Management Systems Audit TeamsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.

The purpose of this course is to equip learners with an understanding of the concept of Medical Device Quality Management Systems (MD QMS) and provides an overview of the purpose and requirements of ISO 13485:2016 as a tool for business improvement.The course covers the following content:Introduction and Structure of ISO 13485:2016, Clauses 1 to 3Clauses 4 (Quality Management System) and 5 (Management Responsibility)Clauses 6 (Resource Management) and 7 (Product Realisation)Clause 8 (Measurement Analysis and Improvement)

This course will provide learners with the knowledge and skills required to perform an internal audit, based on the Medical Devices Quality Management System (MD QMS) requirements of ISO 13485:2016.The course covers the following content:Introduction to Medical Device QMS and ISO 13485:2016; Clause 4 (Quality Management System), Clause 5 (Management Responsibility), Clause 6 (Resource Management), Clause 7 (Product Realisation) and Clause 8 (Measurement Analysis and Improvement)Audit: Definition, Principles and TypesRoles and Responsibilities of AuditorsPlanning and Preparation for the Audit, including On-site ActivitiesAudit Reporting and Follow-up

The objective of this course is to provide learners with the knowledge and skills required to perform an internal audit of part of a WHO GDP requirement as well as in accordance with ISO 19011:2018 as applicable and contribute to the continual improvement of the management systems.The course covers the following content:Introduction to GDPGDP basic requirements - hardwaresGDP basic requirements - softwaresValidation and qualificationOther good practicesAudit definitions, types and principlesRoles and responsibilities of auditorsPreparing for the internal audit, conducting the audit and audit review

Through a series of interactive sessions and hands-on workshops, become familiar with the World Health Organisation (WHO) Good Distribution Practices (GDP) for Pharmaceutical and Medical Device Products, in order to help you ensure compliance.

The purpose of this course is to familiarise learners with an overview of ISO 14971:2019 Medical Devices Application of risk management to medical devices and the differences between the 2012 and 2019 version.Course ContentIntroduction to ISO 14971:2019Planning for risk managementRisk analysis and evaluationRisk controlUsability and risk managementReport and post-production informationOn completion of this course Learners will be issued with a "Certificate of Attendance"

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