ISO 13485 - Medical Devices Management Systems Lead Auditor

This training is given in English.

Context

The success of the quality management of an organization in the medical devices sector ultimately depends on the system designed to improve its operation continuously. In this context, the Lead Auditor, who verifies conformity with the requirements of the ISO 13485 standard, version 2016, plays a key role.

Qualified Lead Auditors are able to further develop the success of a Medical Devices Management System (MDMS). During this intensive training, the emphasis will therefore be on the role and expertise of the Lead Auditor.

Target audience

Managers of audit teams and auditors seeking to broaden and deepen their audit competences when performing external audits of suppliers or for certification purposes. This training is required for auditors to be registered as Lead Auditor of an MDMS.

To get the most out of this training, knowledge of the ISO 13485 standard is necessary. Do you not have any prior knowledge of this standard? Take a look at the training offer of the NBN Academy.

Results

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

5-day ISO 13485 Lead Auditor training:

  • Day 1: 9.00 - 18.00
  • Day 2: 8.30 - 18.00
  • Day 3: 8.30 - 18.00
  • Day 4: 8.30 - 18.00
  • Day 5: 8.00 - 12.15 exam

The Lead Auditor training is intensive. It ends with an exam on the final day of the training. If you pass this exam, you will receive the certificate of qualified Lead Auditor.

The training lasts five days and is in English. The price of the training includes lunches, coffee breaks as well as training materials. Dinner and hotel accommodation are not included. The participants must take into account evening assignments. These assignments take an average of two hours per night.

Advantages

The training is organized in cooperation with the British Standards Institution (BSI). BSI is market leader in the field of auditing and certification, such as ISO certification. During this training BSI uses very recognizable examples from the certification practice. A major advantage!

In-company training

In this type of training your requirements provide the starting point. A preliminary interview will help us adapt the content of the session to your particular needs. In-company training offers a number of specific advantages:

  • The training is tailored to the specific needs of your company. This means that your employees will be able to apply their newly acquired knowledge more rapidly after the training session.
  • Your employees will feel more involved because the exercises and cases will be specific to your company or business sector.
  • Lower cost per participant than for individual trainings.
  • Greater flexibility in the choice of the location, date and language of the training (Dutch, French or English).

 

For further information, please contact us.

NBN Academy

The NBN Academy assists organisations in understanding and applying standards. The NBN Academy is part of NBN (Bureau for Standardisation). It organises open trainings as well as in-company training on management standards. NBN is the single point of contact in Belgium for anyone wishing to develop or buy standards, or to follow training in applying management standards.

General terms and conditions

Click here for the General terms and conditions of the NBN Academy.