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ISO 13485 Lead Auditor Training

Can't travel? This class is also available virtually.

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 call, over 5 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. Learn about our virtual delivery.

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.

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.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
VIRTUAL DELIVERY (PM) 05/18/2020 9 $2895.00 Call to Register CONTACT US
VIRTUAL DELIVERY (AM) 05/18/2020 9 $2895.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 06/01/2020 9 $2895.00 Add to Cart CONTACT US
Orlando, FL 06/01/2020 5 $2895.00 Add to Cart CONTACT US
San Diego, CA 06/08/2020 5 $2895.00 Add to Cart CONTACT US
Chicago, IL 06/15/2020 5 $2895.00 Add to Cart CONTACT US
Boston, MA 06/22/2020 5 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 07/13/2020 5 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 07/20/2020 5 $2895.00 Add to Cart CONTACT US
Austin, TX 07/27/2020 5 $2895.00 Add to Cart CONTACT US
Orlando, FL 08/03/2020 5 $2895.00 Add to Cart CONTACT US
Salt Lake City, UT 08/10/2020 5 $2895.00 Add to Cart CONTACT US
San Diego, CA 08/10/2020 5 $2895.00 Add to Cart CONTACT US
Edison, NJ 08/17/2020 5 $2895.00 Add to Cart CONTACT US
Ann Arbor, MI 08/24/2020 5 $2895.00 Add to Cart CONTACT US
San Jose, Costa Rica 09/07/2020 5 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 09/14/2020 5 $2895.00 Add to Cart CONTACT US
Chicago, IL 09/21/2020 5 $2895.00 Add to Cart CONTACT US
Boston, MA 09/28/2020 5 $2895.00 Add to Cart CONTACT US
Denver, CO 10/05/2020 5 $2895.00 Add to Cart CONTACT US

Course Objectives

  • 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 Instuctor-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.

Number of 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.

Training Schedule

This training is delivered across 9 days. Each session except for the final session is 3.5 hours per day. The final class is extended by 2 hours in order to administer the final exam.

Public seminars class times are either "Virtual (AM)" or "Virtual (PM)."

  • AM classes run 8:30 a.m.-12:00 p.m. EST for the first 8 days, and from 8:30 a.m. - 2:00 p.m on the final day.
  • PM classes run 1:30-5:00 p.m. EST for the first 8 days, and from 11:30 a.m. - 5:00 p.m. on the final day.

A typical public Virtual seminar schedule for this class would run:

Week 1

  • Monday -- AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Tuesday -- AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Wednesday -- AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Thursday - AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Friday - AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM

Week 2

  • Monday - AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Tuesday - AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Wednesday - AM Session: 8:30 - 12:00 PM, PM Session: 1:30 – 5:00 PM
  • Thursday - AM Session: 8:30 - 2:00 PM, PM Session: 11:30 – 5:00 PM 

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

Technical /Logistical Requirements

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

  • A computer with reliable, high-speed Internet connection. Broadband is preferable to WiFi.
  • Latest version of browser Firefox, Chrome, Microsoft Edge or Safari.
  • A USB-connected or built-in web cam.
  • A headset with microphone (USB connection recommended).
  • If possible, two monitors; one for the virtual classroom and the other for viewing training materials.
  • A comfortable workstation and a quiet environment.
  • To close your email browsers and refrain from using your phone during the training.
  • Tablets and mobile devices may lack some essential functionalities and are not recommended.

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

On-Site Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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