ISO 13485:2016 Auditor Training

Kód kurzu: PD631844

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ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system, and how to demonstrate compliance to meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.  Estimated to take up to 15-hours to complete.

Objectives

By participating in this online course, you will be able to:

  • Explain the high level requirements and intent of this international standard
  • Explain how the requirements can be interpreted/should be implemented in various industries
  • Identify the requirements for managing an organization’s QMS in compliance with ISO 13485:2016
  • Interpret how the requirements can be interpreted/should be implemented within an organization
  • Assume a productive role in an audit of your organization’s quality management system as outlined in ISO 13485 and ISO 19011

Odborní
certifikovaní lektori

Mezinárodne
uznávané certifikácie

Široká ponuka technických
a soft skills kurzov

Skvelý zákaznicky
servis

Prispôsobenie kurzov
presne na mieru

Termíny kurzov

Počiatočný dátum: Na vyžiadanie

Forma: TOD

Dĺžka kurzu: 365 dní

Jazyk: en

Cena bez DPH: 340 EUR

Registrovať

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dátum
Miesto
konania
Forma Dĺžka
kurzu
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Na vyžiadanie TOD 365 dní en 340 EUR Registrovať
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Kontakt

Štruktúra kurzu

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  • ISO 13485
  • Introduction to ISO 19011:2018
  • Managing an audit program
  • Planning and conducting an audit
  • Competence and evaluation of auditors
  • Additional guidelines for planning and conducting audits
  • Case studies on auditing to ISO 13485
Materials Provided
  • 365 days of online single-user access (from date of purchase) to the approximately 15 hours of instruction
  • Continuous assessment to check knowledge and application of key concepts
  • Follow-up to your content questions