ISO 13485 Lead Auditor Training Course

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ISO 13485 Lead Auditor Training Course

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Learn how to conduct effective audits of quality management systems for medical devices. Expert instruction, engaging class discussions, and workshops use ISO 13485:2016 as the primary audit criteria. Workshops reinforce key topics with hands-on practice opportunities. Our course teaches the audit discipline according to ISO 19011:2018 while providing a sector-focused learning experience for professionals in the medical device industry.

During our in-person class, over five rigorous days, you will go through every phase of an audit, so you will be able to lead audits against the ISO 13485 standard efficiently and effectively. Our instructor-led virtual class (nine half-day sessions) achieves the same objective through an interactive online delivery.

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Course Date

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location	Start Date	Days	Cost	Public	Private
San Jose, Costa Rica	12/05/2022	5	$2895.00	Add to Cart	Contact Us
VIRTUAL DELIVERY (Eastern Time)	12/05/2022	9	$2895.00	Add to Cart	Contact Us
VIRTUAL DELIVERY (Eastern Time)	01/09/2023	9	$2895.00	Add to Cart	Contact Us
San Diego, CA	01/30/2023	5	$2895.00	Add to Cart	Contact Us
VIRTUAL DELIVERY (Eastern Time)	02/06/2023	9	$2895.00	Add to Cart	Contact Us
VIRTUAL DELIVERY (Central European Time)	02/13/2023	9	$2895.00	Add to Cart	Contact Us
Chicago, IL	03/20/2023	5	$2895.00	Add to Cart	Contact Us
VIRTUAL DELIVERY (Eastern Time)	03/27/2023	9	$2895.00	Add to Cart	Contact Us
San Jose, Costa Rica	03/27/2023	5	$2895.00	Add to Cart	Contact Us
Edison, NJ	03/27/2023	5	$2895.00	Add to Cart	Contact Us

Course Detail

Course Objectives

Note: All attendees must study the current published version of ISO 13485 before attending class. Evening study recommended. A 2-hour final exam is required.

Quality Management System (QMS) Basics – Describe the core components of an effective QMS.
QMS Requirements – Describe the ISO 9000 standard series as well as analyze requirements of and relationship between ISO 9001:2015 and ISO 13485:2016.
Auditing Basics – Describe the audit cycle, auditor responsibilities, and identification of audit-related risks and opportunities.
Process- and Risk-Based Approach to Auditing – Describe how to use a process- and risk-based approach to increase the value of your audits.
Audit Planning – Learn how to plan all aspects of an audit, including creating working documents.
Performing the Audit – Learn how to conduct the opening meeting, collect and verify information (including sampling concepts), listen/question effectively, and generate audit findings.
Recording and Following Up on the Audit – Learn how to present audit results, conduct a closing meeting, and do needed follow-up.
QMS Certification – Describe the third-party QMS certification process.

Course Topics

Interpretation and use of ISO 13485:2016 as audit criteria
The audit cycle and ISO 19011:2018
Audit planning activities
Process and risk-based auditing techniques
Interviewing and listening techniques
Evidence collection techniques and sampling
Nonconformity reporting
Audit follow-up and corrective action

Who Should Attend

This course was originally designed to train third-party auditors, but most attendees lead their company’s QMS implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program who has auditing experience and/or has completed an internal auditor course.

Exemplar Global-Certification

Oriel STAT A MATRIX is a registered training provider with Exemplar Global and this virtual instructor-led ISO 13485 Lead Auditor training course provides evidence of knowledge and skills aligned with their auditor personnel certification schemes. To successfully complete the course, you must earn a passing grade in the course assessments and pass the final online examination. To enroll in an Exemplar Global auditor personnel certification program, you will need to register with Exemplar Global and may need to complete additional requirements such providing an audit log.

Course Pre-Work

All participants must read – and be familiar with the contents of – the ISO 13485:2016 standard before attending this course.
We strongly encourage participants to bring a personal copy of the ISO 13485:2016 standard that you can mark up during the class. We can provide the standard electronically for your use during the training (if needed), but due to copyright restrictions we cannot give out a downloadable file.

Virtual Half-Days

9
In-Person Full-Days

5
CEUs

4.4

Virtual Session Details

The learning objectives and topics covered during virtual instructor-led training (VILT) are the same as those for the in-person version of the course. As well, all VILT classes are taught by the same experienced team of instructors you’ve come to expect from Oriel STAT A MATRIX. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment. Each virtual session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

This class is delivered across 9 consecutive business days.
Unless otherwise noted, the first 8 days run daily 1:00 - 5:00 p.m.; the final session runs 11:30 a.m. - 5:00 p.m. to allow time for administering the final exam.
- Classes run either on Eastern time or Central European time as indicated in the virtual class "Location" field
This convenient half-day format allows you to balance your other responsibilities while still getting the training you need.