Basic seminar ISO 13485

During this seminar you will learn to understand the ISO 13485 standard, to implement its requirements and to create the conditions for successful audits and certifications.

Objective

The seminar gives participants a solid overview of ISO 13485:2016. During the seminar, you will work out the essential content of this standard and derive the required tasks and documents from it.

The seminar empowers the participants

• to understand the standard and its requirements,
• to have an overview of the necessary processes and to check their implementation in the company,
• to create a list of necessary documents and ensure their existence,
• understand and prepare for the process of audits and certifications.

The seminar participants also learn how they benefit outside the EU when they implement the requirements of ISO 13485.

Content of the seminar

• Benefits of ISO 13485

Why should a manufacturer use ISO 13485?

• Creation of a norm

How is a norm created? Who writes them? What variants are there?

• Structure of the standard

What are the chapters/contents of the standard? Which interfaces to other standards exist?

• Compulsory ToDos

What must necessarily be implemented from the standard? What is optional?

• Audits of the standard

How does an audit work? What certificates do successful organizations receive?

• The ISO 13485 seen globally

How do users also benefit outside of Europe? Are there additional requirements there?

Specialities and process

The participants themselves actively develop the learning material in several sprints under the guidance of the trainer. Therefore, we do not send any documents ahead of the seminar. After the seminar, you will receive a summary of the content you have worked out so that you can store the knowledge you have acquired and look it up at any time.

This not only results in more sustainable learning, you also benefit from the specific results because you can use and implement them directly in your company. This makes the seminar an investment that pays off immediately.

Target group

The seminar is aimed at employees of medical device manufacturers and their service providers who are new to quality management in their company. The seminar is also aimed at people who want to establish ISO 13485 in their company and have had little or no experience with it.

The seminar is particularly suitable for:

• New employees in quality management
• Quality management representative
• Future internal auditors

All interested parties