Maximize your learning and your time when you take advantage of an additional day of insight through ISO 13485:2016 Appreciation and Interpretation part of this select course package. This course package combines...ISO 13485:2016 Appreciation and Interpretation (Day 1) & ISO 13485:2016 Internal Auditor (Day 2 & 3) - An Appreciation courses provides you with the foundational information to understand quality management systems and how process effectiveness directly links with business performance and in an Internal Audit course, you’ll learn how to audit processes for effectiveness and efficiency.
You will learn the structure of ISO 13485:2016 and how it interrelates with the Plan Do Check Act cycle. The differences between EN ISO 13485:2012 and ISO 13485:2016, and how the principal changes defined in the new standard may be accommodated by an organization that already has ISO 13485 certification and the transition timelines that apply.
Learn the principal changes introduced in ISO 13485:2016, together with the new and enhanced requirements, in order to recognize to what extent your Quality Management System requires adapting, as well as the differences between ISO 13485:2003 / EN ISO 13485:2012 and ISO 13485:2016.
Understand the best practices to conduct an effective internal quality management system (QMS) audit in accordance with the requirements of ISO 13485:2016 and ISO 19011:2011, and how to add value to your organization and improve the effectiveness of the QMS.
Learn how to design and implement an effective quality management system (QMS) based on ISO 13485:2016. Recommended if you are preparing for ISO 13485 certification, or if you want to improve the effectiveness of your existing QMS.
This five day course is designed to give you a detailed understanding of the role and responsibilities of an Auditor or Lead Auditor, covering topics including audit processes and planning, gathering objective evidence and evaluation of audit findings.
Learn the differences between ISO 13485:2003, EN ISO 13485:2012 and ISO 13485:2016, as well as the essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements