ISO 13485 Internal Auditor training course

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Beschrijving

An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2018.

Delegates learn how to…

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An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2018.

Delegates learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS

Who should attend?

Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.

Prerequisites:

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

Delegates will be able to:

  • explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
  • identify the key principles of auditing and auditor responsibilities
  • plan an internal audit
  • conduct an effective audit based on process identification, sampling and questioning
  • determine if corrective action has been effectively implemented

ISO 13485:2016 learning path and combination discount

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

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

1. ISO 13485 Introduction - € 690,-

2. ISO 13485 Implementation - € 1375,-

4. ISO 13485 Lead Auditor - € 3250,-

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
If more employees need to understand, implement, audit, your management system, training can be delivered at your location. Based on your learning needs we could provide a customized in-house training course for your team.

For more information about the learning path or in-house training courses, please contact our training team.

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 our training team.

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.

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