Page 22 - BSI Training Brochure 2021
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Medical Devices
ISO 14971
Implementing ISO 13485:2016* ISO 13485:2016 Lead Auditor* Introduction to Risk Management for
Medical Devices
This course has been designed to provide you with This course teaches the key principles and
the knowledge and process steps to enable you to practices of effective quality management system This course helps medical device professionals
effectively implement a quality management audits in accordance with ISO 13485:2016 and ISO gain an understanding of how ISO 14971 can
system in line with the requirements for ISO 19011, “Guidelines for auditing management improve their business and risk management
13485:2016. The course introduces the concepts systems”. Participants will gain the knowledge and efforts. You’ll also understand how ISO 14971
needed to understand, develop and implement a skills to plan, conduct, report and follow up a QMS applies to ISO 13485. The training includes
quality management system. audit that establishes conformity and enhances exercises, and you’ll have the chance to ask
overall organizational performance. questions about ISO 14971 and risk management,
Duration 2 days
includes optional online exam Duration 5 days so you can apply what you learn to your
organization.
Duration 1 day
In-house training
ISO 13485:2016 Internal Auditor ISO 13485:2016 Senior Management
Briefing
This intensive course is intended for medical
device quality professionals aiming to build on As a leader, your commitment and support is
their knowledge of ISO 13485:2016 and evaluate crucial to the success of your organization’s ISO
the effectiveness of the quality management 13485:2016 Medical Devices Quality Management
system in their organization. System (QMS). This interactive briefing, delivered
online, highlights your responsibilities in terms of
Duration 2 days leadership and commitment.
includes optional online exam
Duration 2 hours
To become a qualified Internal or
Lead Auditor, you can follow our
BSI Auditor Qualification pathway.
bsigroup.com/en-ZA I +27(0)12 004 0279 I bsi.za@bsigroup.com 22
