Introducing ISO 13485 Clause by Clause

This two day course explores the requirements of the ISO 13485:2016 Quality Management System standard, clause by clause, and provides a clear understanding of the key principles of the standards as well as the steps needed to implement ISO 13485:2016 within your organisation.

The course will help you:

• Understand the scope and purpose of ISO 13485:2016

• Understand the structure of ISO 13485 and its relationship with other standards and regulations

• Understand the intent and requirements of ISO 13485:2016, clause by clause breakdown of the Standard

• Understand the key differences between ISO 13485:2016 and ISO 9001:2015

• Understand the requirements for ISO 13485 certification

This is an interactive course developed and delivered by our experienced Medical Device Certification team.

Throughout the course, you will have the opportunity to ask questions of our team as well as discuss ideas with other delegates, helping you better understand the next steps in your engagement with ISO 13485:2016

At the end of the course you will:

• Have a clear understanding of the core principals and requirements of the standard

• Understand the next steps you need to take towards ISO 13485:2016 certification

• Understand how you and your organisation can better meet regulatory requirements

• Discover opportunities to improve existing processes and quality management systems

• Understand the next steps in developing safe and effective medical devices

The training will be delivered either in person or on-line.

Course Structure

Day 1

• Welcome & Introductions

• Background & Purpose of the Standard

• Structure of ISO 13485:2016

• Clauses 1, 2 & 3: Scope and Definitions

• Clause 4: Quality Management System

• Clause 5: Management Responsibility

• Review of the Day

Day 2

• Review of Day 1

• Clause 6: Resource Management

• Clause 7: Product Realization

• Clause 8: Measurement, Analysis & Improvement

• Requirements & Expectations for ISO 1348 certification

• Review & Final Quiz

Who should attend?

The course is aimed at anyone involved in the implementation of ISO 13485:2016, including:

• New staff within organisations already certified to ISO 13485

• Anyone new to ISO 13485

• Organisations looking to move from ISO 9001 to ISO 13485

• Manufacturers looking at entering the Medical Device market

For manufacturers who have already implemented ISO 13485, this course is ideal as a refresher for those with knowledge of the standard and for anyone with experience with ISO 9001 but who is now looking to better understand how ISO 13485 differs.

It is also ideal for:

• Senior Management

• Quality & Regulatory Managers

• Internal & External Auditors

• Consultants

Key benefits of this course

This is an interactive course developed and delivered by our experienced Medical Device Certification team.

Throughout the course, you will have the opportunity to ask questions of our team as well as discuss ideas with other delegates, helping you better understand the next steps in your engagement with ISO 13485:2016

At the end of the course you will:

• Have a clear understanding of the core principals and requirements of the standard

• Understand the next steps you need to take towards ISO 13485:2016 certification

• Understand how you and your organisation can better meet regulatory requirements

• Discover opportunities to improve existing processes and quality management systems

• Understand the next steps in developing safe and effective medical devices