Fundamentals of ISO 13485:2016 – Medical Device Quality Management Systems

Course Overview

This is a foundation course which is ideal for anyone interested in learning the intent of 13485:2016 as well as how to apply its principles and requirements to establish, implement and operate a quality management system based on 13485:2016.

This course can be delivered on-line or on-site, and is usually a precursor module to the Auditor, Lead Auditor, Consultant and/or Coach courses for 13485:2016.

Main Topics

Introduction to 13485:2016
Medical Device Quality Management System Principles associated with 13485:2016
Workshop on the Medical Device Quality Management System Principles related to 13485:2016
Improvement tools and methodologies
The requirements of 13485:2016
Workshop for applying the requirements of 13485:2016

Learning Objectives

Understand the Medical Device Quality Management Principles upon which 13485:2016 is based
Learn the requirements and intent of 13485:2016
Learn how to apply the requirements of 13485:2016
Learn how to identify Medical Device quality-related risks and opportunities
Obtain the tools needed to achieve your organization’s Medical Device Quality Objectives

Teaching Methodology

Our methodology is practical and is based on the analysis of actual cases allowing the participant to obtain an appropriate balance of theory and practice, thereby facilitating learning and performance.

Workshops

This course includes support materials and interactive workshops that help students achieve the learning objectives.

Duration

This course is 8 hours in duration and can be taken on-line delivered onsite.

Requirements for attaining the certificate of successful completion

Complete the theory lectures online or onsite.
Complete two application workshops

ALL STANDARDS AND TRAINING COURSES OFFERED

Fundamentals of ISO 9001:2015 – Quality Management Systems
Fundamentals of ISO 13485:2016 – Medical Device Quality Management Systems
Fundamentals of ISO 14001 – Environmental Management Systems
Fundamentals of FSSC/ISO 22000:2018 – Food Safety Management Systems
Fundamentals of ISO 18788 :2016– Security Operations Management Systems
Fundamentals of ISO 27001:2013 – Information Security Management Systems
Fundamentals of ISO 45001:2018 – Occupational Health & Safety Management Systems
Fundamentals of ISO 50001:2018 – Energy Efficiency Management Systems
Fundamentals of ISO 22301:2012 Business Continuity Management Systems
ISO 37001:2016 Anti-bribery Management Systems
ISO 22301:2012 Business Continuity Management Systems
AS 9100:2016 Quality Management Systems for Aerospace Industry
TL 9000:2016 Quality Management Systems for Telecommunications Industry
ISO 14298:2013 – Management of Security Printing Processes
ISO/IEC 19770-1:2017 IT Asset Management
Fundamentals of ISO 20121:2012 Event Sustainability Management Systems
ISO 21101:2014 Safety Management System for Adventure Tourism Organization
ISO 30301:2011 Information and Documentation Management Systems for records
ISO 37101:2016 –Sustainable Development Management System
ISO 39001:2012 –Road traffic Safety Management Systems
ISO 41001:2018 –Facility Management System
ISO 44001:2017 –Collaborative business relationship Management System
ISO 55001:2014 –Asset Management Systems

CERTIFICATE PROGRAMS FOR THE ABOVE STANDARDS

ISO Management Systems AUDITOR – Based on ISO 19011:2018
ISO Management Systems LEAD AUDITOR – Based on ISO 19011:2018
ISO Management Systems CONSULTANT
ISO Management Systems COACH