ISO 13485 (ISO 9001) Certified Lead Auditor Training

This AQS Management System's RABQSA certified course is presented as a two-part blended learning class in association with QualityWBT Center for Education. Part I is web-based training (on-line class) and Part II is instructor-led (face-to-face training). Both parts must be successfully completed to meet RABQSA requirements for QMS auditors. Compared to the 36 hour (5 day) certified lead auditor class, the blending learning class offers cost savings, lower travel expenses and less time away from your home and job.

The class is for managers and auditors who want to: 1) learn about ISO 13485 requirements, 2) interpret the standard, 3) apply QMS requirements to their work situation, and/ or 4) receive RABQSA QMS auditor training. This class provides on-line access to ISO 9000 (vocabulary standard), ISO 13485 Checklist standard, and over 20 downloadable handouts such as:  example documents, a Student Textbook, Study Tips, a before-class assessment and after-class objectives. Students must submit an assignment for grading as part of Part I of the class. Students wanting a copy of the ISO 13485 standard must provide their own (purchase or borrow one). Purchasing recommendations and options are covered in the Introduction to class rules, features and navigation. The subscription period for part I (the on-line part) of the class is 90 days (an RABQSA requirement). The registration fee covers the entire class (both the on-line training (Part I) and instructor-led 2 day class (Part II).

The instructor-led two-day class (Part II) must be started within 1 year of successfully completing Part I (e-learning portion). Part II is presented by AQS Management Systems as a 2 day instructor-led class on the application of specific face-to-face auditing skills. The face-to-face (Part II) class is offered every 90 days. Successful completion of both parts of the class will result in a certificate for 36 contact hours (3.6 CEU's).

Learning Outcomes
Students will be able to:

  • Describe how the ISO 9000 family of documents was developed·
  • Interpret the ISO 9001 and ISO 13485 specific requirements·
  • Analyze audit results·
  • Describe the conformity assessment process·
  • Interpret requirements for auditor certification·
  • Compare roles and responsibilities of audit participants·
  • Evaluate management system documentation·

Technical Requirements

  • Intel Pentium processor/compatible
  • 800x600 resolution color monitor
  • 32 MB of RAM recommended
  • 28.8 kb ps modem okay, high speed access preferred
  • A browser such as Internet Explorer, Netscape, Firefox
  • Acrobat Reader (free plug-in)
  • Flash/Shockwave Player (free plug-in)
  • Java Script (installed on most computers)


Mark Ames has more than 25 years of experience in quality management and instruction. Mark offers his students a wealth of knowledge. He is the author of AQS Management System's RAB Accredited ISO 9000 and ISO 14000 Lead Auditor programs, and has consulted with more than 200 organizations that have successfully registered to these standards. A former faculty member at the University of St. Thomas, Ames is president and founder of AQS Management Systems. Questions? Click here to contact Mark.


J.P. Russell is owner of JP Russell and Associates ( and Managing Director of QualityWBT Center for Education ( Mr. Russell is an ASQ Fellow, an ASQ Certified Quality Auditor, and former RAB QMS Lead Auditor. He is a member of ASQ, Standards Engineering Society, and the US TAG TC176 (Quality Management System standards). Mr. Russell has been a speaker at several national conferences and regional organizational meetings and is an ASQ qualified instructor.

JP is an instructional designer in the areas of auditing, standards, and improvement; has authored over 12 books on process/systems auditing/continual improvement, edited the Quality Audit Handbook 1st and 2nd ed, and the ASQ Auditng Handbook, and is a regular columnist for ASQ's Quality Progress magazine.
Questions? Click here to contact JP.

Course Developer: QualityWBT Center for Education/ J.P. Russell & Associates/ AQS Management Systems, Inc.
Content Provider: AQS Management Systems, Inc. and JP Russell & Associates

International Association for Continuing Education & Training (IACET) Authorized Provider of CEUs