ISO 13485 Kwaliteitsmanagement voor medische hulpmiddelen Lead Auditor training course

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ISO 13485 Kwaliteitsmanagement voor medische hulpmiddelen Lead Auditor training course

BSI Group
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Beschrijving

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.

You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake …

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Nog niet gevonden wat je zocht? Bekijk deze onderwerpen: ISO 13485, Lead Auditor, Auditing (financieel), Medisch en Kwaliteitsmanagement.

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to the quality of medical devices by transforming existing auditor skills to ISO 13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.

You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. Acquire the skills to initiate, plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

Who should attend?

  • Anyone with the need to audit an organization’s ISO 13485:2016 QMS like:
  • Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management Representatives
  • Quality Directors
  • 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 course.

It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits.

Delegates will be able to:

  • identify the purpose and benefits of an ISO 13485:2016 QMS
  • explain the role of an auditor to plan, conduct, report and follow up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
  • plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)

ISO 13485:2016 learning path and combination discount

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

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

1. ISO 13485 Introduction - € 690,-

2. ISO 13485 Implementation - € 1.375,-

3. ISO 13485 Internal Auditor - € 1.375,-

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

Combination training 1 + 2 € 1.965 | € 100 korting
Combination training 1 + 3 € 1.965 | € 100 korting
Combination training 1 + 4 € 3.765 | € 175 korting
Combination training 1 + 2 + 3 € 3.215 | € 225 korting
Combination training 1 + 2 + 3 + 4 € 6.290 | € 400 korting

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

  • The Lead Auditor is an intensive training course and will be completed by an official BSI exam
  • It's a 5-day course (first days at least till 18:00)
  • The training and materials will be provided in English
  • Lunch and drinks are included.
  • There is a requirement for delegates to undertake some evening preparation or assignments on days 1-4 (Approximately 2-3 hours)

For further information regarding reduced rates at the hotel where the training is being conducted please contact us.

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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