ISO 13485:2016 Medical Device - Quality Management Systems Requirement and Interpretation (Live Online Training)

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.

*** SGS also provide e-certificate and e-document (e-document will be provided for In-house training only). This enables leaners to be free from certificate loss, to reduce storage space, and ultimately to be environmental-friendly to which SGS’s current policy is attached.***The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of to ISO 13485:2016 and to contribute to their continual improvement. This intensive training aims to provide delegates with the skills required to conduct internal audits, using interactive training by medical device lead auditors experienced in ISO 13485 and Notified Body audits.

- This training course includes the lecturing and practical workshop to encourage all attendant learn the principle risk assessment applicable for medical device manufacturing operation compliance ISO 14971:2019:- The delegate will also learn and practice the interpretation of standard requirement and the application of all standard clause applicable all standard requirement.- These also include key issue and technical consideration related to product and process characterization, risk involve in design and manufacturing phases, where all risk will be identified, minimized and control through the development of the related manufacturing management system.- At the end of this training course the attendant will equip with knowledge and practical approach to be able to plan, prepare and implement Medical device – application of risk management to medical devices.