ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor Course - Complying with Requirements

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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.

ISO 14971 is unique risk management for medical device industry. It provides a systematic approach for whole process on risk management, for design to post production phases. To demonstrate that we have an established system to eliminate, reduce and manage risks to our medical devices. COURSE OUTLINE:What is Risk? ISO 14971 Standard briefing Relationship between different countries WorkshopsTest PROFESSIONAL TRAINER: Tutor with more than 10 years of working experiences in auditing the medical device and electronic appliance industry. Experiences across R&D, Production Technique, Quality Assurance & Quality Management System. (SGS Hong Kong Ltd. reserves the right of final tutor arrangement.) CERTIFICATION (Attendance: 100%): Delegates who successfully completed the course and passed the test will be issued a certificate by SGS Hong Kong Limited. GENERAL INFORMATION: Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / HKSTP/ TBC Medium: Cantonese supplemented with English materials * Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking **Discount will be offered to HKMHDIA members