ISO 13485:2016 Lead Auditor (TPECS) Connected Learning Live

BSI America
Training overview
Professional Course
10 days

Course description

ISO 13485:2016 Lead Auditor (TPECS) Connected Learning Live

BSI Connected Learning is a live,online training that combines premier skills development technologies with our expert instructors to deliver an engaging, interactive learning experience to you, regardless of location. This is an ideal alternative to the typical classroom setting for quality professionals who do not have the budget or time for travel, or just prefer the convenience of attending a class without having to leave their own personal environment.

BSI's “ISO 13485:2016 Lead Auditor” competency-based course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of leading management systems and process audits in accordance with ISO 19011:2018, “Guidelines on Auditing Management Systems”. Experienced instructors explain the clauses of ISO 13485:2016 in detail and guide students through the entire audit process, from managing an audit program to reporting on audit results. Qualified instructors will help you to boost your audit capabilities with the latest developments of the new 19011 standard.  Students gain necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions.

This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD - Medical Device Systems
  • AU - Management Systems Auditing
  • TL - Leading Management Systems Audit Teams

Virtual delivery options may also be available for this course. Get in touch to learn more!

Want to find out more?

COVID-19 Update

In light of COVID-19, this provider is now delivering some or all of their courses online. Contact them for more information!

Who should attend?

Who Should Attend:

  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Management Representatives
  • Quality Directors in Medical Device
  • Managers
  • Engineers
  • Consultants

Prerequisite:

A prior review of the ISO 13485:2016 standard is required and internal audit experience is suggested for this course. 

Training content

Learning Objectives:

  • 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
  • Apply ISO 19011:2018 concepts, new terminology and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an audit adopting a risk-based approach
  • Prepare and present effective reports
  • Understand Exemplar Global's certification scheme
  • Understand the role of objectives, scope and criteria in the audit process
  • How to plan audits
  • Conduct audit team selection
  • Initiate the audit and conducting opening meetings
  • Understand audit team leader responsibilities
  • Communicate effectively during the audit
  • Apply the latest auditor techniques and identify appropriate use
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Certification / Credits

Attendees successfully completing this course receive a Certificate of Competency for each of Exemplar Global Competency Units listed above.

Why choose BSI?

Leading provider of business improvement solutions

Base of 65,000+ clients across the globe

Training services available in 150+ countries

About BSI

BSI America

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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Contact info

BSI America

12950 Worldgate Drive, Suite 800
20170 Herndon, VA

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bsi.learncentral.com

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