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ISO 13485:2016 Internal Auditor (TPECS)

BSI America
Training overview
Length: 3 days
Provider: BSI America plus
Training type: Classroom / Public

ISO 13485:2016 Internal Auditor (TPECS)

ISO 13485:2016 Internal Auditor (TPECS)

ISO 13485:2016 Internal Auditor (TPECS) 

A competency-based course, BSI's ISO 13485:2016 Internal Auditor course teaches the general principles and applications of the ISO 13485:2016 standard, as well as the requirements of effective internal auditing in accordance with ISO 19001.

The three day program is intended for quality professionals in the medical devices industry who require a solid foundation and understanding of:

  • The clauses of ISO 13485:2016
  • Internal audits for quality management systems based on ISO 13485
  • The purpose and significance of the ISO 9000 series
  • The duties and responsibilities of the internal auditor

Led by highly experienced instructors, the course combines formal classroom tutorials with role-playing exercises, group workshops and open discussions that favor interaction between the delegates and enhance the learning experience.

Who should attend?

This course is suitable for individuals interested in conducting, managing or participating in internal audits of medical device management systems.

Prerequisites
A prior review of the ISO 13485:2016 standard is required and an understanding of auditing principles is suggested for this course. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class Essentials of ISO 13485:2003 prior to attending the classroom training.

Training Content

On completion of the training, delegates will:

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 13485:2016 standard
  • Understand the roles and responsibilities of the auditor

Costs

The course fee is USD $1550 per person.

Early bird discounts are available for those booking in advance.

Training Locations

This course is offered at multiple locations. Contact BSI for details.

Provider: BSI America

BSI America Training Courses

BSI America - Management systems training for a skilled, competent workforce

With 58 offices serving over 65,000 clients across 150 countries, BSI is a leading global provider of business improvement solutions and training for organizations looking to embed excellence into their daily routines. Through local offices based in the US, BSI...


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