ISO13485 Quality Lead Auditor QAI Training LLC
10 N. Van Buren Street Suite 100
P.O. Box 372
Nashville, IN 47448

Print Course Info:   Course Offered:
Course Hours: 32      

About the Course

ISO13485 Lead Auditor training in four days. 

Since redesigning our competency based lead auditor courses in 2005, QAI has taught thousands of people how to be effective auditors, audit  team members, and audit team leaders.  Our succesful pass-fail rate of over 99% proves that point.  Without changing anything but course timing, QAI brings you lead auditor training in 32 hours and students, bosses, and company budgets across the country are loving it. 

About the course:

Led by energetic, enthusiastic, and experienced internationally certified auditors you'll get more than just a pretty face at all QAI training sessions. Designed as a competency based training class, you can forget about the 'boot camp' days of lead auditor training: this class runs 8a-5p each day.  No long nights with mounds of homework.  Come see how competency based training is different.

In this QMS Lead Auditor course, you get real-world, professional know-how partnered with outstanding training materials.  A handsome, durable, and professionally prepared student book will display smartly and unmistakably and will serve you nicely in your reference section for years to come. Finally, you get the support of an ISO9001 registered training company. 

With multiple, progressive learning approaches including hands-on practice auditing, our QMS Lead Auditor training course prepare graduates to become proficient and professional QMS auditors. 

The course includes a complete and thorough review of the QMS standard including a look back at the history of quality leading up to the current QMS system.  Our big picture course section helps cement the financial side of the QMS and helps students to best understand how a QMS really works ($$).

Lecture topics will include implementation and documentation strategies and methods. Workshop activities are designed to strengthen your ability to assess a QMS system and its compliance to the standard.

Group case studies with mock auditing reinforce the learning process and help to familiarize you with process auditing. The course is designed around an actual case study of a facility and its’ Quality Management Systems. Students end the course conducting an assessment of the case study facility and making a recommendation on registration. 

Under the new competency requirements program, we administer examinations throughout the course so that you get feedback right away and throughout the course about how well you are doing.   When you leave this course you will already know if you have passed the course: no more waiting for results of a final examination like the old boot camp days of Lead Auditor training. 

If you're in line to take a lead auditor training class, you're really going to like the new competency based training format used by QAI in all of our Lead Auditor training classes.  This format helps ensure that the entire class is progressing, understanding, and comprehending the material using competency based skills testing at various points throughout the class.  We've taught thousands of persons using this format.  Students like this format because they know if they have passed when they leave the class not weeks later.  Instructors like this format because they get feedback along the way about well they are doing in transferring critical knowledge.  It is a blend that works for everyone.

Course Hours:  Four days 8a- 5p

Course Objectives:

  • Create competent lead auditors of an ISO13485 QMS
  • Help students understand and to interpret the standard from an auditors perspective
  • Help students to design systems and to improve systems such that they fit into the 'big picture' of financial business planning
  • To aid students in developing good auditing work habits so that they can become good, impartial auditors for the workplace
  • Help students become integral members of their management team
  • Help students understand the need for competent audits to be performed in the market
  • Help students help other to continually improve their QMS
  • Help students to competently assess a complete ISO13485 QMS for conformance to requirements
  • Help students to write good, objective audit reports that aid in making effective corrective actions on a system
  • To make students into professionals
  • To make professionals better

You will get great training, a professional and certified auditor as an instructor, an outstanding student reference guide/workbook, and sales and service from an ISO9001 registered company. And ,you get all of this at an unbelievable price if you can plan ahead and pay ahead with QAI.

Successful completion of training:

Students that successfully complete this course will pass a series of competency assessments, evaluations, and examinations that will lead to certification as a competent auditor. 

  • The ISO13485 QMS program manager at the company.
  • Persons interested in gaining information and auditing skills critical to the new revision
  • Any person that is about to lead the effort for system implementation at the company
  • New members of the Management Representative Staff .
  • Those individuals that have inherited the reins for the QMS program at the company.
  •    There are currently 0 upcoming classes for this course.
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    $2,400.00 Cost Per Attendee Before Discount
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    10 N. Van Buren Street Suite 100
    P.O. Box 372
    Nashville, IN 47448



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