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ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor 

  • Offered bySGS

ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor
 at 
SGS 
Overview

Empowering Internal Auditors: Medical Device Quality Focus

Total fee

32,803

Mode of learning

Online

Official Website

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Credential

Certificate

ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor
 at 
SGS 
Highlights

  • Earn a certification after completion
  • Learn from expert faculty
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ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor
 at 
SGS 
Course details

Skills you will learn
What are the course deliverables?
  • Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
  • Know how to conduct internal quality system audits
  • Understand the role of internal audits in the maintenance and improvement of management systems
  • Plan and prepare for an internal audit
  • Learn to gather evidence by observation, questioning and sampling
  • Write factual reports on the compliance of the management system against the audit standards
  • Participate in the corrective action process
More about this course
  • Our training solutions are developed by subject matter experts to help organizations and individuals improve personal competence and skills
  • This intensive training aims to provide delegates with the skills required to conduct internal audits, using interactive training by medical device lead auditors experienced in ISO 13485 and Notified Body audits
  • The training comprises presentations, workshops and interactive role-play exercises with medical device lead auditors experienced in ISO 13485 and Notified Body audits.

ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor
 at 
SGS 
Curriculum

Basic principles of ISO 13485:2016

A step-by-step guide of ISO 13485:2016 requirements

Detailed explanations of each requirement and quality system links between the requirements

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ISO 13485: - Medical Devices Quality Management Systems - Internal Auditor
 at 
SGS 

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