ISO 9001 Lead Auditor Course

ISO 9001 Lead Auditor Course Outline

Module 1: Definition and Fundamentals

• International Organisation for Standardisation (ISO)

• Introduction to ISO 9001

• Basic Terminology of Quality Management System (QMS)

• Principles of Quality Management System (QMS)

• ISO 9001 Family of Standards and Versions

• ISO 19011:2018

• Fundamentals of ISO 9001:2015
   

Module 2: Structure

• ISO 9001:2015 and its Clauses

• Process Approach

• PDCA Cycle

• Layout Standards that Follow the PDCA

• Scope and Limitations

• Limitations of ISO 9001

• Benefits of ISO 9001
   

Module 3: Internal Audit Structure

• Auditing Types, Procedures, and Planning

• Auditing Techniques

• Phases of an Audit

• Assessment of Audit Reports and Documents
   

Module 4: Internal Auditor

• Roles

• Responsibilities

• Leadership Skills
   

Module 5: Audit Programme

• Audit Programme

• Process Audit Checklist
   

Module 6: Audit Report

• Audit Reports

• Audit Findings

• Follow-Ups
   

Module 7: Procedures

• Procedures in Reference to the 9001:2015

• Scope of QMS

• Objectives of a QMS

• Policies of a QMS
   

Module 8: Methods to Operate a QMS Efficiently

• Challenges Faced During Implementation

• Methods to Operate a QMS Efficiently

• Implementation Process
   

Module 9: Risk Management

• Risk and Opportunity

• Risk-Based Thinking

• Conducting Risk Assessments

• Risk Assessment Methodology

• Risk Assessment Implementation

• Risk Register
   

Module 10: Roles and Responsibilities of a Lead Implementer and Quality Team

• Roles and Responsibilities of a Lead Implementer and Quality Team

• How to Maintain QMS Structure?

• Corrective Actions

• Records

• Sequential Operation Process

• Measurement and Monitoring of Processes

• Controlling of Errors
   

Module 11: Lead Auditor Training

• Roles and Responsibilities of a Lead Auditor

• Team Selection and Planning

• Lead Auditor Requirements, Scope, and Procedures

• Design and Development

• Tips for Lead Auditors

• Report Preparation, Findings, Reconciliation, and Conclusions
   

Module 12: Audit Activities and Techniques

• Opening Meetings

• Daily Discussion Meetings

• Closing Meeting

• Presentation of Reports

• Non-Conformance Report

• Tools and Techniques
   

Module 13: Methods of Collecting Information

• Visual Observation

• Examination of Records

• Employee Interviews
   

Module 14: Certification

• Certification Process for Organisations

• Selecting an ISO 9001 Registrar

• Steps to Certification

• Prepare for the Certification Audits

• Stage 1 Audit

• Stage 2 Audit

• Re-Certification Audit

What You’ll Learn in this Course

This course takes you from understanding ISO 9001 requirements to mastering advanced auditing practices. Each stage of the journey builds the expertise needed to lead successful QMS audits.
 

• Learn the structure and requirements of ISO 9001 standards

• Learn how to plan and prepare for internal and external audits

• Learn to lead audit teams with confidence and professionalism

• Learn techniques for gathering, verifying, and analysing audit evidence

• Learn to report audit findings and recommend improvements

• Learn how to drive continual improvement within organisations through effective auditing

ISO 9001 Lead Auditor Exam Information

To earn the ISO 9001 Lead Auditor Certification, candidates must successfully pass an examination. The exam structure is outlined below:

• Question Type: Multiple Choice 

• Total Questions: 30 

• Total Marks: 30 Marks 

• Pass Mark: 50%, or 15/30 Marks 

• Duration: 40 Minutes

• Open Book/ Closed Book: Closed Book