ISO 13485:2016

• Introduction and Background
• Key Differences to ISO 13485: 2016
• 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:DraftingQuality 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)
• Team Exercises on both days

Programme overview

The ISO 13485 standard “Quality Management Systems. Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc.

This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions

Some of the key changes to ISO 13485:2016 include:

Inclusion of risk management across all process activities

Additional requirements for design activities

Additional requirements for process validation and verification activities

Improvement in supplier control processes using a risk-based approach

Increased emphasis on feedback methodologies

Explicit requirements for quality system software

For outsourced processes control based on risk and ability to meet specifications and requirements

Detailed requirements in Technical file

Management Review frequency determination

Learning outcomes

Understand regulatory requirements around ISO13485:2016

Understand key changes from 2003/2012

Who is the course for

Validation Engineers

Quality Engineers Personnel planning ISO13485:2016 introduction

This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.