Quality Management System according to EN ISO 13485:2016 - in practice

Establishing an effective Quality Management System (QMS) is crucial for most organizations in the medical device supply chain. For some markets, it is even a must. The harmonized EN ISO 13485:2016 standard offers a structured way to successfully establish such a QMS, fulfilling applicable sections of both Medical Device Regulations (MDR 2017/745 and IVDR 2017/746).

This course explains the requirements of the standard in a clear and coherent way and exemplifies its interpretation and application in different kinds of organizations. The course provides a basic understanding of the requirements and how to design, deploy, and maintain a working QMS.

From the program

• ISO 13485 – History, purpose, scope and future
• QMS – The big picture, CE-marking
• Relationship with ISO 9001 and MDR/IVDR
• Relationship with other Management System Standards and legal requirements
• Details of requirements and interpretation of EN ISO 13485:2016
• Challenges and best practices

Target group

This course is intended for personnel working with quality assurance, product development, production and management, including internal auditors, process owners, and regulatory staff at companies within the medical device supply chain.  

Educational goals

After the course, participants will have a basic understanding of the standard and how to establish and maintain a QMS based on it.  

Prior knowledge

A basic knowledge of management systems and experience from the medical device domain is recommended.  

Course presentation and language

Course material is in English. The course is held in Swedish or English, as specified next to each course date.  

Course leader

Cilla Lundevall Wiberg, Principal Quality & Regulatory Consultant, has 25+ years of experience working with quality assurance in various positions in several medical device organizations with different product types. The course is conducted in collaboration with Aurevia. 

Please note:

Intertek operates under strict standards of independence, impartiality, and integrity. Read more about how we work here: https://www.intertek.com/about/compliance-governance/

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