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Medical Devices
Our ISO 13485 quality management training will help you to understand the QMS requirements for medical devices,
so you can ensure that you maintain compliance By attending training on ISO 14971 you can understand how to improve your business through risk management efforts and understand how ISO 14971 applies to ISO 13485
ISO 13485
Introduction to ISO 13485:2016
This course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers
Duration 1 day
ISO 13485:2016 Clause by Clause
This course has been designed to provide an in depth understanding of ISO 13485:2016 by reviewing the requirements of each clause in turn, allowing you to maintain a compliant QMS
Duration 2 days includes optional online exam Implementing ISO 13485:2016
ISO 13485:2016 Lead Auditor
This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems” Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance
Duration 5 days
Once you’ve successfully completed Internal or Lead Auditor training,
you can follow our BSI Auditor Qualification pathway.
ISO 14971
Introduction to Risk Management for Medical Devices
This course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts You’ll also understand how ISO 14971 applies to ISO 13485 The training includes exercises, and you’ll have the chance to ask questions about ISO 14971 and risk management, so you can apply what you learn to your organization
ISO 13485 and ISO 14971
This course has been designed to provide you with the knowledge
and process steps to enable you to effectively implement a quality management system in line with the requirements for ISO 13485:2016 The course introduces the concepts needed to understand, develop and implement a quality management system
Duration 2 days includes optional online exam ISO 13485:2016 Internal Auditor
This intensive course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization
Duration 2 days includes optional online exam In-house training
ISO 13485:2016 Senior Management Briefing
Duration
1 day
As a leader, your commitment and support is crucial to the success of your organization’s ISO 13485:2016 Medical Devices Quality Management System (QMS) This interactive briefing, delivered online, highlights your responsibilities in terms of leadership and commitment
Duration 2 hours
16 bsigroup.com/training I 0345 086 9000 I training@bsigroup.com
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