ISO 9001 Lead Auditor Class (Exemplar Global) 5-day
(Plexus International)
Learn the full range of auditing skills that will help you become a strong advocate in your healthcare organization’s effort to obtain maximum value from your commitment to ISO 9001. Participants will acquire the necessary skills to become a leader in preparing and conducting audits through interactive methods and avoiding lecture based learning. This course is designed for healthcare participants and is accredited by Exemplar Global.
 
Prerequisites: A series of questions to be answered by the student and turned in prior to or at the beginning of the course to demonstrate understanding of the ISO 9001 Standard

Learning Objectives:
  • Perform audits based on ISO 19011 Standard 
  • Demonstrate an understanding of ISO 9001 
  • Apply Exemplar Global Auditor Certification Handbook 
  • Link to Quality Management Principles 
  • Form an audit team 
  • Conduct an audit meeting 
  • Determine needed documentation and organize to the standard 
  • Classify, record and resolve non-conformities 
  • Implement preventive measures to avoid future non-conformities

Who should attend:

  • Any member of an ISO 9001 implementation team 
  • Trainers who want an effective method of explaining ISO 9001 to employees 
  • Representatives from key functional groups involved in an organization’s quality management system

Course Agenda:

Day 1 
  • Introduction 
  • Review Student Requirements 
  • Review Course Agenda 
  • Review Written Examination and Continual Evaluation Information
  • Understanding ISO 9001 Standard, specifically as related to healthcare

Day 2 
  • Understanding ISO 9001 Standard, specifically as related to healthcare

Day 3 
  • Linkages to Quality Management Principles Activity 
  • Review Auditor Certification Handbook 
  • Auditing Skills 

Day 4 
  • Auditing Skills 
  • Audit Applications 

Day 5 
  • Audit Applications 
  • Written Examination

Certificates Awarded
  • Those who pass will receive a certificate of successful completion, which satisfies the training requirement for individual QMS auditor certification by Exemplar Global (formerly RAB-QSA). 
  • Those who do not pass will receive a certificate of attendance.

Materials include copies of the following standards:
ISO 9000: Fundamentals and Vocabulary                                                                                                                
ISO 9001: Management System Requirements
ISO 9004: Managing for Sustained Success in an Organization
ISO 19011: Guidelines for Audit Management
ISO 17021: Requirements for Certification Bodies