Course  Overview

This Certified ISO 9001Lead Auditor Training Course is based on assisting and verifying the competencies/capabilities of the Learner to be able to effectively audit a complete QMS based on ISO 9001:2015 requirements with specific emphasis of 2nd Party auditing [Customer/Supplier audits] and 3rd Party auditing [Certification Bodies].

During the delivery, the Learner will complete a Consultant facilitated complete systematic audit of a QMS. The facilitated audit of the QMS will cover the full audit life cycle as defined by ISO 19011and the Learner will have to demonstrate and be assessed on the effective application of audit tools and techniques.

Learning Outcomes

We cover new and additional topics in more depth. We focus on auditing that provides Assurance that the Quality Management System meets the needs of the interested parties & our Learners are equipped to make higher quality insights for improved organizational performance.

Course Basics

·         This is a 5-days (30hr) learning event.

·         Start/Finish Times: 04:00pm – 10:00pm (each day)

·         Prior Learning Requirement: Learners are required to be familiar with ISO 9001:2015 requirements or have completed a recognized QMS Fundamentals course based on ISO 9001:2015 prior to registering for this course.

Learning Topics

Course Introduction

·         The Business/Societal Case for ISO 9001:2015

·         Purpose and Impact of Annex SL

·         New and Revised Terminology

·         The Relationship between External & Internal Issues, Interested Party Requirements

·         Risks and Opportunities

·         Leadership

·         Effective Communication and Life Cycle Thinking

Introduction to Auditing

·         Audit Terminology, Principles, QMS Audits

·         Auditor Code of Ethics

·         Management of an Audit Program

·         Audit Terminology, Principles, QMS Audits

·         Audit Life Cycle (On-site & Off-site Audit Activities)

·         Auditor/Auditee Roles, Responsibilities*

·         Desired Auditor Behaviors

·         Process Terminology

·         Process Models/Methodology & Categories

·         Evaluation of the effectiveness of a Process

·         Processes and the application of POCA & Risk

·         The QMS Certification Cycle & 3rd Party Certification

·         Special Conformity Audits

·         Audit Planning

·         Initiating & Preparing for the Audit

·         Audit Trails

·         Purpose and benefits for establishing initial contact and forms of contact

·         Case Study: Document Review

·         Audit Plan

·         Audit Checklist

·         Audit Protocol

Opening Meeting

·         Purpose, process and benefit of an Opening Meeting

·         Case Study - Opening Meeting

Onsite Activities

·         Lead Auditor Leadership and Supervision

·         Responsibilities of the Lead Auditor

·         Communication throughout the Audit Life Cycle

·         Monitoring Audit Progress

·         Consensus and Resolution Conflicts

·         Lead Auditor Leadership

·         Audit Reporting

·         Audit Follow-Up

·         Auditor{Technical  Expert Coaching, Mentoring and Evaluation

·         Collecting and Verifying Information

·         Introduction to Audit Findings

Audit Reporting

·         Audit Findings

·         Case Study: Writing Audit Findings

·         Case Study: Writing the Audit Report

Completing the Audit

·         Evaluating Correction & Corrective Action including Root Cause Analysis and Audit Finding Closure

·         Audit Follow Up Strategies

·         Final Audit Team Meeting Closing/Exit Meeting & Role Play

Course Certification

This course is conducted under the license of Quality Academy QA

How Will I be assessed?

The delegate is assessed based on participation and performance

Throughout the duration of the course, this includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

There is a 2 hour written examination at the end of the course. The exam is closed book in that a delegate is entitled to use only their copy of the International Standard (s) in question or dictionary if delivery language is not their native language. The minimum pass rate for the examination is 70%.

Who Should Attend?

·         Quality Managers

·         Quality Professionals/Technicians

·         Quality Engineers

·         Procurement Personnel

·         Financial Personnel

·         Document Controllers

·         Internal Auditors

·         Owner Managers

·         Implementation Members