(Team Leader and Auditor Modules RABQSA Certified)

Every organization needs key people to lead, coordinate and follow through on audits. The lead auditor courses have been designed with these people in mind. This course is set up to prepare students to look at their management systems like your certified body auditors (registrars). This course is competency based.

The ISO 13485 Lead Auditor modules of Team Leader and Auditor have been certified by RABQSA International.

Students are taught the standard requirements in detail and how to view objectively a complete system. The course walks them through how to plan, manage and perform audits from a process approach. Please note in the ISO 13485 Lead Auditor Course it includes the map back to the Quality System Reguirements for CFR 820 medical device.

Students will actually perform process audits in a “safe environment” to learn proper techniques in questioning and digging for information. Also, write an audit report with non-conformances. Finally, as a Lead Auditor you will learn group and team dynamics and leadership skills. Be prepared to learn, work and have fun. Please anticipate homework every night for 1 to 2 hours.
Successful Completion satisfies the attainment requirements for that specific module(s) and can be used to apply for auditor status with RABQSA International.

Course Agenda

Day One
Agenda, Objectives/Introductions – Terms, Definitions, Concepts – Purpose of the Standards – Clauses – Case Studies

Day Two
Clauses – Case Studies – Documentation – Work Sheet -Roles/Responsibilities – Facts/Inferences Activity – Audit Concepts and Types – Process Audits/Plans – Audit Plan and Agenda Activity – Homework Assignment – Desktop Audit and Report

Day Three
Checklist Development and Interview Techniques – Positive Audits and Lead in Questions – Self-Assessment Audit – Process Audit Mechanics – Audit Preparation Activity – Process Audit Activity – Closing Meeting/Compiling Audit Findings – Audit Report Writing – Wrap Up Meeting Activity – Homework Assignment – Audit Report

Day Four
Follow Up Action – Audit Preparation #2 – Process Audit
Activity #2 – Closing Meeting/Conclusion Activity – Work Sheet – Course Closure

Included with the class is the course book, materials and a certificate of completion.

Training Location:
Country Inn and Suites
320 Oak Avenue
Menomonie, WI 54751
715-235-5664

Click Here for a printable map.

If the course is shown as full, call River Systems at 715-235-0329 to inquire about possible openings.

September 26-29, 2011 – Country Inn & Suites, Menomonie, WI
Price: $1045 per person – Order On-Line through PalPal or with major credit card.