In-house training: ISO 13485 - Medical devices

Safety and quality are literally of vital importance when it comes to medical devices. That’s why experts from all over the world gathered their expertise and know-how in an international standard: ISO 13485.

The standard establishes the requirements for an effective quality management system and does so for all relevant parties: from suppliers to producers to distributors. The goal? To guarantee optimal quality throughout the whole lifecycle of medical devices.

Last but not least, also internal and external auditors of quality management systems based on ISO 13485 need to be up to date all the time. Therefore, the NBN Academy organises in-house training programmes for different target groups.

The NBN Academy: your training partner for the use of standards

  • As the only Belgian member of ISO and CEN, NBN is at the source of everything concerning standardisation. Your benefit? You’re always the first to know about new developments.
  • The trainers at the NBN Academy are experienced experts. They are also active in standardisation commissions for management standards, so they share first-hand information.

Why choose an in-house training programme?

You’re in control. You choose the location, time and language (English, French or Dutch) of the training. After the intake meeting, during which we assess your objectives and the profile of all participants, we draw up a tailor-made programme.

 

Just getting started with ISO 13485? Sign up for a basic training

Is your team not entirely familiar with the ‘how’ and ‘why’ of a quality management system for medical devices, then this is the first step towards success:

Basic training ISO 13485

A two-day course on the most important requirements and how you correctly implement them in your organisation. Risk management is at the heart of this course.

Expand your expertise on ISO 13485? Sign up for an advanced audit training

For more experienced standard users who want to fully grasp the concept of a quality management system for medical devices, the NBN Academy offers two options:

Training Internal lead auditor ISO 13485

An intensive, five-day course on risk-based auditing (ISO 19011) and managing audit teams. At the end, you present an exam to become a qualified lead auditor.

Training Lead Auditor ISO 13485

This intensive training highlights the role and competence of the Lead Auditor. Participants are presented with tools and methods used to assess the conformity of the MDMS.

At the end of this 5 day training:

  • you will be able to interpret the ISO 19011 standard for management systems audits
  • you will know how to apply the ISO 19011 standard for performing audits according to ISO 13485:2016
  • you will understand the objectives and content of the standards ISO 19011, ISO 9001 and ISO 13485, as well as their interrelationships
  • you will be able to initiate, prepare, perform, finalize and follow up an audit
  • you will be able to draw up and discuss an audit report
  • you will know how to collect audit evidence according to ISO 19011
  • you will know how to lead an audit team
  • you will be able to assess the conformity of the MDMS with ISO 13485:2016