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.
DurationThis 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
Why Choose Us
A trusted partner helping you solve problems, deliver safe and reliable products and achieve a competitive edge.
Eurofins E&E UK has over 25 years’ experience providing CE marking and regulatory compliance solutions and services. We act as the trusted provider of regulatory compliance solutions for leading brands and companies in the UK, Europe and worldwide.
Reasons to choose Eurofins E&E UK
We are committed to providing the highest quality services and to deliver them professionally and in an accessible and friendly way
We provide ongoing guidance and assistance and add value to your products
We strive to be your trusted regulatory compliance partner
Our rates are very competitive
Our range of testing services include diagnostic to fully accredited
Staff at Eurofins E&E UK are experts; highly knowledgeable and experienced to cater to your needs
Fast turnaround times to enable you to get your product to market quickly
Flexible service as we understand that even your best laid plans will sometimes need to change
All of our services are within the scope of our quality system, either ISO 17025 or ISO 9001.
Why our customers use us
Reliable service
You can rely on our technically competent professionals to make the process of attaining compliance as painless as possible; from initial test identification to our rapid report delivery.
Added value
Our staff are experts in both testing and finding cost effective solutions should remedial work be required.
Flexible solutions
We provide full advice and guidance while you meet regulatory compliance standards and help to minimise your business risk in the process.
The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.
This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.
The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to ...
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
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