API Lead Auditor Training (Q1 or Q2)

Overview

In this 3-day intensive course, you will gain a thorough understanding of how to audit a quality management system, at the same time enhancing your knowledge and skills through an interactive and practical approach to auditing. The course offers a hands-on approach that enables you to apply various auditing techniques through real-world scenarios and role-play.

This course uses ISO 19011:2011, “Guidelines for Auditing Management Systems,” as the basis for teaching the auditing techniques discussed throughout the course. To apply these auditing techniques, this course teaches how to audit an API Spec. Q1 quality management system using real-world case studies, developed to hone your understanding and practical application of how to document audit notes and nonconformities.

This course is ideal for those interested in internal auditing and/or lead auditing. For those pursuing an API auditor certification, this course fulfills the training requirement for all API auditor certification schemes

Reserve Your Seat Today

Need more information? View our list of Frequently Asked Questions.

[Note: For those attendees who wish to explore auditor case studies that are specifically tailored to an API Spec. Q2 or ISO 9001:2015 management system,  we will offer a 1-day extension workshop focused on highlighting the relevant areas pertaining to either Q2 or ISO 9001. Please mention your interest in this option when registering for a public course.

If your company would like a private lead auditor training course that focuses on the specs. or standards of your choosing (API Spec. Q1, Q2, or ISO 9001:2015), please complete an Onsite Training Form and detail the specifics of your request.] 

Who Should Attend?

This course is ideal for those already familiar with or working under a management system standard (API Q1, Q2, ISO 9001, etc.).

NOTE: There are no prerequisites for the course; however, it is recommended that you have a working understanding of a management system standard prior to registering for this course. For training in your standard, visit our Training Services page for additional information.

• Quality system auditors
• Personnel involved in managing their organization’s audit program or in leading audits of their organization’s management system
• Professionals seeking certification or continuing education to maintain their certification
• Auditors looking to upgrade their auditing skills
• Personnel responsible for assisting their organization in achieving conformity to API Spec. Q1, Q2, ISO 9001:2015, or other management system standard

Course Material

• Training participant workbook
• Practical exercises
• Case studies
• Copy of API Spec. Q1

Learning Objectives

Upon completion of this course, you will learn gain an understanding of:

✅ ISO 19011, Guidelines for Auditing Management Systems

✅ Process auditing and management system interfaces

✅ Audit schedule, plans, objectives, and scope

✅ How to manage an audit program

✅ Auditing and interviewing techniques

✅ Objective evidence and how to record it

✅ Audit behavior, traps, and what not to say

✅ Documenting audit notes and nonconformances

✅ Conducting audit follow-up and corrective action effectiveness

Course Agenda

• Requirements and Definitions
• Principles of Auditing
• Auditor Behavior and Competency
  • Personal objectives for auditing
• The Audit Program and Structure
  • Process Auditing
  • Management system interfaces
• Responsibilities of the Audit Team
• Beginning the Audit
• Objective Evidence
• The Audit Process
  • Audit plans
• Documenting Audit Nonconformities
• Ending the Audit
  • Preparation for audit exit meeting
  • Conducting the audit exit meeting
• Audit follow-up