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ISO 13485 Lead Auditor Training

Exemplar Global Logo  Certified Lead Auditor Training Course

Updated to reflect the revised ISO 19011:2018 (issued July 2018), the standard for auditing quality management systems

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.

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.

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.

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
San Diego, CA 07/22/2019 5 $2695.00 Add to Cart CONTACT US
Minneapolis, MN 07/29/2019 5 $2695.00 Add to Cart CONTACT US
Raleigh, NC 08/05/2019 5 $2695.00 Add to Cart CONTACT US
Chicago, IL 08/12/2019 5 $2695.00 Add to Cart CONTACT US
San Francisco Area, CA 08/19/2019 5 $2695.00 Add to Cart CONTACT US
Orlando, FL 09/09/2019 5 $2695.00 Add to Cart CONTACT US
Irvine, CA 09/16/2019 5 $2695.00 Add to Cart CONTACT US
Edison, NJ 09/23/2019 5 $2695.00 Add to Cart CONTACT US
Indianapolis, IN 09/30/2019 5 $2695.00 Add to Cart CONTACT US
Boston, MA 10/07/2019 5 $2695.00 Add to Cart CONTACT US
San Diego, CA 10/14/2019 5 $2695.00 Add to Cart CONTACT US
Minneapolis, MN 10/21/2019 5 $2695.00 Add to Cart CONTACT US
San Francisco Area, CA 10/28/2019 5 $2695.00 Add to Cart CONTACT US
San Jose, Costa Rica 11/04/2019 5 $2695.00 Add to Cart CONTACT US
Chicago, IL 11/11/2019 5 $2695.00 Add to Cart CONTACT US
Orlando, FL 11/18/2019 5 $2695.00 Add to Cart CONTACT US
Edison, NJ 12/09/2019 5 $2695.00 Add to Cart CONTACT US
Boston, MA 01/06/2020 5 $2695.00 Add to Cart CONTACT US
Austin, TX 01/13/2020 5 $2695.00 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

Successfully completing this course by passing the course assessments and the final exam satisfies the knowledge requirements for Exemplar Global various auditor personnel certification schemes.  To attain certification from Exemplar Global you must meet prescribed professional requirements and apply to Exemplar Global for recognition. For more details of Exemplar Global personnel certification, please see requirements information at www.exemplarglobal.org.

Number of Days: 5
CEUs: 4.4
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