ISO 13485:2016 Implementation Training Course 

Agenda

This three-day training course will introduce the architecture of ISO 13485:2016  Quality System and will outline the process steps  for implementing an effective ISO 13485:2016 Quality Management System (QMS). 

This course incorporates our Introduction to ISO 13485:2016 training course meaning no prior knowledge is necessary. Key topics include:

Module 1: Scope

Module 2: Normative References

Module 3: Terms and Definitions

Module 4: Quality Management System

Module5:Management Responsibility

Module 6: Resource Management

Module 7: Product Realization

Module8:Measurement, Analysis, and Improvement

Module9:Key - Plant Senior Management "buy in"

Module10:Drafting Quality Manual and Policy Procedures

Module11: Process Maps

Module12: Exclusions to scope

Module 13 CMDAS Linkage

Module14: Linkage to Medical Device Regulation (2017/745)  and In Vitro Medical Device Regulation (2017/746)

Module 15: Introducing gap analysis

Module 16: Understanding the process for developing objectives and implementation plans

Module 17:  How to review an ISO 13486 QMS, including developing an audit programme

Module 18:  The route to certification

Module 15: Quality Management Principles and the key components of a QMS

Module 16:  Risks and opportunities

Module 17:  Agree Action Plan and pathway to successful certification of an ISO 13485 QMS

Learning Objectives

Delegates attending this ISO 13485 implementation training course will be able to:

• Understand the architecture  and benefits of ISO 13485
• Understand the process for a gap analysis and what is required to implement ISO 13485
• Support others in applying and integrating ISO 13485 into existing business operations
• Understand regulatory requirements around ISO13485:2016