ISO 13485 Kwaliteitsmanagement voor medische hulpmiddelen Implementation training course

Type product

ISO 13485 Kwaliteitsmanagement voor medische hulpmiddelen Implementation training course

BSI Group
Logo van BSI Group

Tip: meer info over het programma, prijs, en inschrijven? Download de brochure!

Beschrijving

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Delegates develop knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connec…

Lees de volledige beschrijving

Veelgestelde vragen

Er zijn nog geen veelgestelde vragen over dit product. Als je een vraag hebt, neem dan contact op met onze klantenservice.

Nog niet gevonden wat je zocht? Bekijk deze onderwerpen: ISO 13485, Medisch, Kwaliteitsmanagement, Medische Apparatuur en Biomedische.

You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

Delegates develop knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.

This course forms part of our Auditor Qualification programme. To find out more, please visit our training auditor qualification page here.

Gain a Certificate of Achievement for this course

You can now qualify for a Certificate of Achievement, by passing the assessment requirements, including an end-of-course online exam, you’ll improve your professional profile and be able to:

  • Provide evidence of your learning
  • Demonstrate your competence

We will email your exam log-in details when you’ve finished the course. The exam is done online which means you can choose when and where to complete it. You are strongly advised to choose a time and a place where you will not be disturbed, and where you have access to a reliable internet connection. The exam takes approximately 80 minutes, is comprised with 40 multiple choice questions and you have up to 30 days to complete it – including one opportunity for a re-take.

Upon successful completion of this exam you will be awarded a Certificate of Achievement alongside your Certificate of Attendance. If, however, you decide not to complete the exam, you will still be awarded with a Certificate of Attendance. 

Please talk to a member of our training team on +31 (0)20 346 0780 or via training.nl@bsigroup.com if you have any questions in regards to the online exam and your training course.

Who should attend?

Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.

Prerequisites:

You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction training course.

Delegates will be able to:

  • define a quality management system
  • identify the steps for defining, planning, organizing and scheduling necessary activities
  • implement an effective quality management system
  • conduct a base line review of an organization's current position with regard to ISO 13485:2016

ISO 13485:2016 learning path and combination discount

The ISO 13485:2016 Implementation learning path is modular. You can follow the training in all combinations. We recommend the following order:

Besides this implementation course, are the following training courses also part of the ISO 13485 learning path: 

1. Introduction ISO 13485 - € 690,-

2. Implementation ISO 13485 - € 1.375,-

3. Internal Auditor ISO 13485 - € 1.375,-

4. Lead Auditor ISO 13485 - € 3.250,-

Attending several training courses of a learning path is associated with special discounts. 

Combination training 1 + 2 | € 1.965 | € 100 discount

Combination training 1 + 3 | € 1.965 | € 100 discount

Combination training 1 + 4 | € 3.765 | € 175 discount

Combination training 1 + 2 + 3 | € 3.215 | € 225 discount

Combination training 1 + 2 + 3 + 4 | € 6.290 | € 400 discount

In-house training course
For more information about the learning path or in-house training courses, please contact our training team via +31 20 346 0780 or send an email to training.nl@bsigroup.com. 

Practical information

  • It's a 2-day course
  • The training and materials will be provided in English
  • Lunch and drinks are included

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-346 0780.

BSI biedt een grote diversiteit aan praktijkgerichte trainingen. Door onze centrale rol in de commissies waarin de normen tot stand komen, kennen wij de inhoud van een norm tot in detail en zijn wij in staat om u informatie uit de eerste hand te leveren.

Daarnaast weten wij als wereldwijde certificatie-instelling precies hoe organisaties met de normen in hun eigen organisatie om kunnen gaan. Het onderscheidend vermogen van de trainingen wordt o.a. gekenmerkt door de focus op praktijkgericht en effectief leren middels interactieve opdrachten.

Blijf op de hoogte van nieuwe ervaringen

Er zijn nog geen ervaringen.

Deel je ervaring

Heb je ervaring met deze cursus? Deel je ervaring en help anderen kiezen. Als dank voor de moeite doneert Springest € 1,- aan Stichting Edukans.

Er zijn nog geen veelgestelde vragen over dit product. Als je een vraag hebt, neem dan contact op met onze klantenservice.

Vraag nu gratis en vrijblijvend informatie aan:

Aanhef
(optioneel)
(optioneel)
(optioneel)
(optioneel)
(optioneel)