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

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

New to TPECS?

For more information, please see our Understanding the TPECS Course Structure page.

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

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. 

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.
• Please bring a picture ID such as a driver's license, passport, or work badge to class for verification purposes.

*Session lengths could vary depending on amount of class discussion.

Full Day Classes - (Live Online and In-person) There are 4 eight hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 2, 3, and 4. Exams range from is 90-120 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s).

Half Day Classes - (Live Online) There are 8 four hour sessions*, one per day. There are online exams at the end of each competency unit, which are in sessions 4, 6, and 8. Exams range from is 90-120 minutes. Detailed exam instructions will be provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each. Certificates of Attendance are provided to those who do not pass the competency exam(s), and students will be given the opportunity to retake the test(s).