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ISO 13485 Lead Auditor Training

Our virtual instructor-led version of this class runs as 9 half day sessions.  See virtual delivery details here.

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 several 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 achieves the same objective through an interactive online delivery.  

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 Course Private
VIRTUAL DELIVERY (PM) 08/10/2020 9 $2895.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 08/31/2020 9 $2895.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 09/21/2020 9 $2895.00 Add to Cart CONTACT US
Boston, MA 09/28/2020 5 $2895.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 10/12/2020 9 $2895.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 11/02/2020 9 $2895.00 Add to Cart CONTACT US

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.

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.

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 Schedule

Virtual Class Days: The first 8 days run daily 1:30-5:00 p.m. EST; the final session runs 11:30 a.m.-5:00 p.m. EST to allow time for administering the final exam.

In-Person 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.
  • The first 8 days run daily 1:30-5:00 p.m. EST; the final session runs 11:30 a.m.-5:00 p.m. EST to allow time for administering the final exam.
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

See course dates to find / register for a virtual session of this course.

VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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